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- 2026-03-10 22:25:31
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- Nubeqa’s indication expanded to msHPC in combo with ADT
- by Whang, byung-woo Jun 24, 2025 06:00am
- Pic of Nubeqa Bayer Korea announced on the 23rd that its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) has been approved by the Ministry of Food and Drug Safety as part of a two-drug regimen in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). With this expanded indication, Nubeqa can now be used not only as part of a three-drug regimen with ADT and the chemotherapy drug docetaxel but also as part of a two-drug regimen with ADT. This enables more flexible treatment approaches tailored to the individual condition and treatment goals of mHSPC patients. The approval was based on the results of the ARANOTE study, a global Phase III clinical trial evaluating the efficacy and safety of the two-drug regimen combining Nubeqa and ADT in 669 patients with mHSPC. Study results showed that the group treated with Nubeqa+ADT had a 46% statistically significant reduction in the risk of radiographic progression or death compared to the placebo group. This improvement in radiographic progression-free survival (rPFS) was consistent across all groups, including high-risk and low-risk mHSPC patients. Also, analysis of overall survival (OS), the secondary endpoint, showed that the Nubeqa combination therapy group demonstrated potential survival benefits compared to the placebo group, with significant delays in PSA progression, deterioration in quality of life, and progression of pain, thereby demonstrating clinically significant improvements in quality of life. The incidence of treatment-emergent adverse events (TEAEs) was low, with most events occurring at Grade 1 or 2, and no significant differences were observed between treatment groups. Nubeqa is already approved in Korea for use in combination with ADT and docetaxel for the treatment of mHSPC patients and for use in combination with ADT for the treatment of high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). With this third indication, Nubeqa is now available for elderly patients and patients who are not suitable to receive chemotherapy. Professor Jae-Young Joung, Director of the Urologic Cancer Center at the National Cancer Center, said, "In prostate cancer, treatment strategy is critically important and needs to be selected based on the stage of diagnosis, disease stage, and the patient's overall condition. Nubeqa is the only treatment approved as both a three-drug regimen with docetaxel+ADT and as a two-drug regimen with ADT in patients with hormone-sensitive metastatic prostate cancer, so the approval will offer more flexible treatment options tailored to the patient's individual circumstances." He added, “Given its favorable tolerability profile, which reduces treatment burden and may positively impact long-term outcomes, we anticipate that it will rapidly improve treatment access for patients in Korea.” Meanwhile, Nubeqa has been approved as a treatment for mHSPC and nmCRPC in over 85 countries worldwide and has surpassed annual sales of approximately KRW 2.4 trillion as of 2024, rising as a blockbuster therapy.
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- 'Fabhalta' closer to being reimbursed, shaking up inj market
- by Moon, sung-ho Jun 24, 2025 06:00am
- Next month, new oral agent will be introduced to the market for paroxysmal nocturnal hemoglobinuria (PNH). Injectables, such as Soliris and Ultomiris, currently dominate the PNH market. Attention is drawn to whether this oral agent will enhance patient satisfaction, as it offers the convenience of administration compared to the previous treatments. Product photo of FabhaltaAccording to pharmaceutical industry sources, the Ministry of Health and Welfare (MOHW) has recently given an administrative announcement on the revision to the "The detailed measure on the application standards and methods of medical reimbursements," which affects the reimbursement status of the Novartis Factor B inhibitor 'Fabhalta (iptacopan).' If there are no special circumstances, Fabhalta can be approved for reimbursement in July. PNH is currently known as a disease with no fundamental cure. However, the approach to treatment is changing with the development of therapies that inhibit the activity of the complement system. The complement system is a core component of innate immunity, serving as a powerful defense mechanism that directly attacks and destroys pathogens. The complement system includes several pathways, including C3 and C5, and ultimately functions to destroy red blood cells by forming the 'Membrane Attack Complex (MAC).' Previous treatments primarily target the terminal component within the complement system's alternative pathway. Treatment settings have been improved with the introduction of Soliris (eculizumab),' a once every 2 weeks injection, and then, 'Ultomiris (eculizumab),' which can be administered via injection at 8-week intervals. These treatments are still commonly used in clinical practices. Fabhalta works by inhibiting Factor B, a crucial component in the activation of C3. In addition to this novel mechanism, Fabhalta is also the first and only single oral agent for PNH treatment in South Korea, offering the advantage of twice-daily dosing. The efficacy of Fabhalta was confirmed in the Phase 3 APPLY-PNH clinical study, which enrolled 97 adult PNH patients (18 years or older) who had received C5 inhibitors for at least 6 months but still experienced anemia (with average hemoglobin levels below 10 g/dL). In a randomized assignment, 35 out of 97 patients continued C5 inhibitor treatment, while the remaining 62 switched to Fabhalta. The impact on treatment outcomes was assessed over 24 weeks. Clinical results showed that patients who switched to Fabhalta experienced normalized hemoglobin levels starting from week 4, with the effect sustained until week 24. Hemoglobin normalization was observed in approximately two-thirds of patients. Furthermore, four out of five patients exhibited a clinically significant increase in hemoglobin levels, and 95% of patients overcame transfusion dependence. Based on these findings, the MOHW plans to apply reimbursement starting next month for PNH patients meeting specific criteria: ▲adults aged 18 or older with a PNH granulocyte clone size of 10% or more (as measured by flow cytometry) with lactate dehydrogenase (LDH) levels at least 1.5 times the upper limit of normal, and for whom C5 inhibitors (Soliris or Ultomiris injections) cannot be administered due to medical reasons. Additionally, ▲reimbursement will apply if patients have received C5 inhibitors for more than 6 months under reimbursement criteria but have hemoglobin (Hb) levels below 10 g/dL or if there is a need for drug switching due to side effects. As a result, clinical practices expect Fabhalta to be able to resolve unmet medical needs that could not be addressed with conventional treatments. Currently, some PNH patients experience unmet needs such as persistent fatigue, insufficient symptom improvement, and transfusion dependency. Even with C5 inhibition, upstream C3 activation continues, often leading to repeated situations where red blood cells are prematurely removed from the bloodstream in the liver·spleen, necessitating transfusions. As a result, Novartis is expected to establish a dedicated team and focus on addressing these unmet medical needs. Dr. Jun Ho Jang, a professor at Samsung Medical Center Seoul, said, "Factor B is a proximal factor that acts as a gate upstream of C5 in the alternative complement pathway. In other words, inhibiting Factor B affects not only C5 but also C3, significantly improving hemolysis that occurs both intravascularly and extravascularly." Dr. Jang added, "Based on these mechanistic characteristics, the efficacy and safety profile of Fabhalta has not only been confirmed in clinical trials for patients without prior C5 inhibitor treatment experience but also showed superior results in patients who switched from anti-C5 therapy to Fabhalta compared to those who continued anti-C5 therapy." Dr. Jang emphasized, "Fabhalta as a single oral formulation offers high convenience for taking medication. It is favorable that we have an effective treatment option with a new mechanism that did not exist before. A paradigm shift in PNH treatment is expected." Meanwhile, PNH is a chronic, complement-mediated blood disorder, a severe rare disease that can be life-threatening. PNH patients have acquired mutations in some hematopoietic stem cells, leading to the production of red blood cells prone to premature destruction, resulting in intravascular hemolysis (IVH) and extravascular hemolysis (EVH). PNH can cause complications such as thrombosis, renal failure, and pulmonary hypertension, potentially leading to death, with a 5-year mortality rate of 35% and a 10-year mortality rate of approximately 50%. It can also impact the quality of life due to symptoms such as anemia and weakness.
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- Tibsovo may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jun 24, 2025 05:59am
- Tibsovo, a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia, can now be prescribed at general hospitals in Korea. According to industry sources, Servier Korea’s IDH1 (isocitrate dehydrogenase 1) genetic mutation targeting therapy Tibsovo (ivosidenib) recently passed the Drug Committee (DC) review of the ‘Big 5’ tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, as well as other medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The company has been steadily expanding its prescription area since it received approval from the Ministry of Food and Drug Safety in May last year and officially launched the drug in September of the same year. In addition, as the drug’s indication for cholangiocarcinoma has recently been approved by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service, expectations are rising for its reimbursement. The drug is indicated for use ▲= in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years with comorbidities that preclude the use of intensive induction chemotherapy, or ▲as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation. Cholangiocarcinoma is a highly aggressive cancer with a poor prognosis, with a 5-year relative survival rate of just 28.9%. In particular, 65% of patients with intrahepatic cholangiocarcinoma are diagnosed at an advanced stage where surgery is not feasible. Tibsovo is the only targeted therapy recommended by the National Comprehensive Cancer Network (NCCN) in the highest category (Category 1) as a second-line treatment for bile duct cancer. According to the Phase III ClarlDHy trial, Tibsovo reduced the risk of disease progression by 63% compared to placebo, with a median progression-free survival (PFS) of 2.7 months (1.4 months in the placebo group). Additionally, the median overall survival (mOS) was 10.3 months in the Tibsovo group, more than twice as long as the 5.1 months in the placebo group. Do-Youn Oh, Professor of Hematology-Oncology at Seoul National University Hospital, stated, “The development of drugs for cholangiocarcinoma has accelerated significantly in recent years. As new drugs are being developed, many companies are also actively working on the development of treatments for cholangiocarcinoma. It is crucial for patients with cholangiocarcinoma to follow the doctors’ guidance and receive appropriate treatment rather than be discouraged, so they can participate in clinical trials and gain access to new treatment opportunities.” Meanwhile, in the Phase III AGILE study that enrolled patients with acute myeloid leukemia, Tibsovo demonstrated improved event-free survival (EFS) when used in combination with azacitidine, and also significantly improved overall survival (OS). The median OS in the Tibsovo-treated group was 24.0 months (7.9 months in the placebo group), and long-term follow-up results showed that the median OS with Tibsovo combination therapy was 29.3 months, over 3.7 times longer than with placebo combination therapy.
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- Eylea biosimilar pharmas receive differing injunction ruling
- by Kim, Jin-Gu Jun 23, 2025 06:01am
- Domestic biosimilar companies have launched a full-scale patent lawsuit against Bayer over Eylea. Celltrion and Samsung Bioepis received different preliminary injunction results, leading them to pursue divergent strategies in the main lawsuit. Eylea patent infringement main lawsuits begin in earnest... Celltrion to proceed immediately, Samsung Bioepis’ plan undecided On the 20th, the 61st Civil Division of the Seoul Central District Court held the second hearing regarding the patent infringement lawsuit filed by Bayer against Celltrion. The hearing concluded without any substantive arguments. The court decided to receive additional written statements from both parties and scheduled the next session for August 19. Bayer filed the lawsuit in January last year. The issue is whether Celltrion's Eylea biosimilar, Eydenzelt, infringes on Bayer's domestic patent. Bayer filed the same lawsuit against Samsung Bioepis in May last year. Bayer claims that Samsung Bioepis' Eylea biosimilar, Afilivu, infringes on its patent. However, no trial date has been set yet for the lawsuit against Samsung Bioepis. Opposite preliminary injunction results... Bayer files appeal, Samsung Bioepis files objection The patent infringement lawsuit surrounding Eylea is proceeding in a complicated manner with mixed preliminary injunction decisions from the court. In July last year, Bayer filed preliminary injunction motions against Celltrion and Samsung Bioepis, respectively, for patent infringement. The purpose was to suspend the domestic sale of biosimilars until the final ruling. In February this year, the preliminary injunction results were announced. The court issued conflicting decisions. The preliminary injunction request against Celltrion was dismissed, while the request against Samsung Bioepis was granted. As a result, Celltrion can continue selling Eydenzelt in Korea, while Samsung Bioepis must suspend sales of Afilivu. Due to the conflicting preliminary injunction decisions, the responses of each company also differed. Bayer filed an appeal with the Seoul High Court regarding the Celltrion case. The appeal hearing is scheduled for next month on the 17th. In contrast, Samsung Bioepis opted for an objection procedure instead of filing an appeal. Along with the objection, the company also filed a request for a stay of execution, but it was dismissed. The objection hearing concluded in April this year, and the case is now awaiting the court’s final decision. Nevertheless, Samsung Bioepis has continued to submit supplementary briefs in response. Preliminary injunction appeal, objection, and final ruling... a turning point for the domestic sale of biosimilars The final ruling, the appeal of the preliminary injunction, and the decision on the objection are expected to serve as a turning point in determining the sustainability of domestic biosimilar sales. If Bayer wins the appeal against Celltrion, the domestic sales of Eydenzelt will be suspended. Conversely, if the rejection is upheld as in the first instance, sales will continue as is. In the case of Samsung Bioepis, if the court accepts the objection, sales of its Afilivu can resume. Conversely, if the court dismisses the objection, sales will remain suspended. In this case, Samsung Bioepis is expected to continue the lawsuit by filing an appeal. The ruling on the main lawsuit is expected to tentatively determine whether the two companies can sell Eylea biosimilars. If the court rules that the two biosimilars infringe on Eylea's patent, sales of Eydenzelt and Afilivu in Korea will be suspended. Conversely, if the court rules that there is no patent infringement, sales of the biosimilars will be permitted. The progress of this complex litigation is directly impacting partner companies that copromote the biosimilars as well. Kukje Pharm, which co-markets Celltrion's Eydenzelt, has continued its sales to date. However, Samil Pharmaceutical, which collaborates with Samsung Bioepis, has suspended distribution and sales of Afilivu. Future developments, including the appeal, objections, and final ruling, are likely to influence the sales strategies and revenue of these partner companies.
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- K-BIO expands its presence at the international convention
- by Son, Hyung Min Jun 23, 2025 06:01am
- Korean pharmaceutical and biotech companies showed their presence at the BIO International Convention 2025 (BIO USA 2025), the world's largest biotech business event. Major domestic pharmaceutical and biotech firms from South Korea attended the BIO USA 2025, held in Boston, USA, from June 16 to 19, showcasing their new drug pipelines and Contract Development and Manufacturing Organization (CDMO) technological capabilities. According to the Korea BIO on June 21, over 20,000 participants from 70 countries attended this year's BIO USA. Among them, the number of Korean attendees exceeded 1,300, marking the third consecutive year that South Korea has been the largest participating country from overseas. BIO USA is the world's largest pharmaceutical and bio exhibition, serving as a platform for global pharmaceutical and biotech companies and research institutions to explore opportunities for new drug pipelines, technology transfer, and collaborative research. Over 300 Korean companies participated in this year's event. Samsung Biologics expressed its commitment to expanding collaborations with global pharmaceutical companies through this event. Samsung Biologics plans to increase its production capacity by securing drug manufacturing contracts from pharmaceutical companies ranked among the top 20 to top 40 globally. Samsung Biologics has signed a total of 5 new contracts based on public disclosures this year alone. Starting with a $1.41 billion (approximately KRW 2 trillion) contract signed with a European pharmaceutical company in January, the company continued to secure new orders globally, including those from the U.S., Asia, and Europe. Samsung Biologics currently holds 17 out of the top 20 global pharmaceutical companies as clients. Through core competencies based on overwhelming production capacity, quality, and numerous track records, its cumulative total orders since its establishment have exceeded approximately $18.2 billion. Lotte Biologics announced the securing of new contracts through BIO USA. The company held a Contract Manufacturing Organization (CMO) agreement signing ceremony for antibody drugs with the British biopharmaceutical company Ottimo Pharma. This ceremony took place at the Lotte Biologics booth at the Boston Convention & Exhibition Center in the United States. Lotte Biologics announced the securing of new contracts through BIO USA Through this agreement, Lotte Biologics will produce the drug substance (DS) for Ottimo Pharma's new antibody drug, 'Jankistomig,' at its biotech campus in Syracuse, New York. Ottimo Pharma is a company developing a new drug with a PD1/VEGFR2 bispecific antibody mechanism, aiming to extend the lives of patients with cancer. Established in 2020, it has offices in the UK. Lotte Biologics offers CDMO services at the Syracuse biotech campus, including drug cell line development and large-scale contract manufacturing. Furthermore, it aims to operate Plant 1 within its Songdo Bio Campus starting in 2027. Plant 1 is a large-scale biopharmaceutical manufacturing facility with a production capacity of 120,000 liters, enabling it to secure significant global contracts. Celltrion held over 150 meetings at this event, discussing various collaboration strategies with global pharmaceutical and bio-companies. Notably, beyond CDMO and biosimilars, the company showcased various potential partnership opportunities for its pipelines under development, including antibody-drug conjugates (ADCs), multispecific antibodies, novel antibodies, and peptide new drugs. Celltrion also discussed open innovation aimed at finding promising technologies related to new drug development. Celltrion plans to thoroughly review the meetings held at this BIO USA to identify potential collaborators with growth potential and capabilities. Celltrion is pursuing the development of new ADC drugs. Earlier this year, Celltrion disclosed the preclinical results of its ADC candidate 'CT-P71'. CT-P71 utilized the ADC platform of the Korean ADC development company Pinotbio. CT-P71 is an ADC therapeutic agent under development targeting general solid tumors, including bladder cancer. It targets Nectin-4, a cell surface protein overexpressed in various solid tumors such as urothelial carcinoma and breast cancer. Celltrion also received approval for a Phase 1 clinical trial of CT-P70. CT-P70 is an ADC therapeutic agent targeting solid tumors such as non-small cell lung cancer, specifically targeting 'c-MET,' which, when activated in cancer cells, induces tumor growth. Korean companies promoted R&D competitiveness for new drug development This year, 51 companies participated in the Korea Section, operated by the Korea Bio Association, introducing technologies and pipelines across the entire biotech industry, including contract manufacturing, clinical services, materials/components/equipment business, new drug development, and platforms. Over 450 consultations were held throughout the exhibition hall. Notably, 24 pre-registered companies garnered attention from global partners through technology presentations at the Open Stage within the Korea Section. This year, both the number of participating companies and the exhibition space expanded compared to the previous year. A special area for materials, components, and equipment business was also operated separately, showcasing the competitiveness of Korea's biotech industry supply chain. Photo of BIO USA 2025 Korea Section (source=Korea BIO organization) In this event, Korean companies also focused on promoting their competitiveness in new drug development. Through BIO USA, Aptamer Sciences actively discussed strategic collaborations with major ADC-specialized companies in North America, Europe, and China, exploring concrete cooperation opportunities such as joint development, clinical collaboration, expansion into new indications, and technology transfer. Aptamer Sciences has proprietary ADC platform technology, ApDC (Aptamer Drug Conjugate). ApDC is a next-generation precision drug delivery platform that utilizes aptamers instead of antibodies, using an in-house modified nucleic acid technology. According to Aptamer Sciences, anti-cancer drugs developed using the ApDC platform have demonstrated various advantages in comparative experiments with ADC anti-cancer drugs, including rapid drug action through quick internalization into target cells after surface binding, excellent permeability into tumor tissue, rapid targeting after administration in animal models, and consequently, superior anti-tumor efficacy. Currently, Aptamer Sciences is expanding its platform to allow conjugation with various mechanisms of action beyond cytotoxic drugs, including radioisotopes, targeted protein degraders (TPDs), and immunostimulants. GI Innovation introduced its new pipelines and global business strategy as its next growth engines. GI Innovation unveiled its GI-128, which utilizes macrophages (a next-generation target gaining attention in the immunotherapy field), along with a trispecific pipeline that aims to surpass the rapidly emerging aPD-(L)1/VEGF bispecific antibodies in the global market. GI Innovation's newly introduced pipeline features a trispecific antibody structure that fuses a self-discovered aPD-L1 antibody with a VEGF antibody and a macrophage engager. It is evaluated as having a differentiated mechanism of action by overcoming the limitations of bispecific antibodies and activating tumor-immune responses. SK Biopharmaceuticals is engaging in artificial intelligence (AI)-driven drug discovery through a business agreement with PhnyX Lab. Through this agreement, the two companies plan to jointly develop customized solutions based on PhnyX Lab's generative AI solution 'Cheiron', automating tasks such as literature search, data analysis, and document creation required in the new drug development process. The agreement signing ceremony took place at the SK Biopharmaceuticals exhibition booth. (from left) Changho Yu, SK Pharmaceuticals VP/Chief Strategy Officer & Head of Strategy Division and Minseok Bae, CEO of PhnyX Lab Notably, SK Biopharmaceuticals plans to accelerate its 'AI Transformation' of the new drug development process, primarily focusing on automating tasks such as preparing regulatory documents required at the clinical entry stage, thereby advancing it with the use of AI. Through this, SK Biopharmaceuticals aims to maximize R&D productivity and significantly reduce the time and cost associated with development and approval. Samjin Pharmaceutical, making its first official corporate presentation at this year's BIO USA, showcased its competitiveness in developing new anti-cancer drugs, including ADCs. Currently, the company is developing various candidates, including ▲solid tumor therapeutic candidates 'SJN301' and 'SJN309' ▲antibody-drug conjugate (ADC) projects 'SJA20' and 'SJA70' ▲immune/inflammatory disease therapeutic candidate 'SJN314'.
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- "6-in-1 vaccine Hexaxim may enhance preventive effect of NIP
- by Whang, byung-woo Jun 23, 2025 06:00am
- "Hexaxim is Korea's first hexavalent vaccine. It is expected to play a crucial role in helping protect children's health." Following the inclusion of Hexaxim, a hexavalent (6-in-1) DTaP vaccine, in the National Immunization Program (NIP) this year, the medical field is holding high hopes for increased convenience of immunization and improvement in vaccination rates. The analysis is that since immunization through NIP has already been conducted, the field is already experiencing practical benefits, such as a reduced number of immunizations. It is believed that, in the long term, Hexaxim will lessen the burden of hospital visits for caretakers, alleviate the stress of infant injections, and prevent the skipping of immunizations. Dr. Byung Wook Eun, Professor of Department of Pediatrics at Nowon Eulji Medical CenterDaily Pharm met with Dr. Byung Wook Eun, a professor at Nowon Eulji Medical Center, and listened to the background of the introduction of Hexaxim and its potential effects. Hexaxim is Korea's first and only fully liquid hexavalent fully liquid formulation vaccine, preventing six diseases, including diphtheria, tetanus, pertussis (DTaP), inactivated polio vaccine (IPV), Haemophilus influenzae type b (Hib), and hepatitis B (HepB), with a single injection. As of January 2, it has been officially introduced into the NIP, allowing the previous separate administration of the pentavalent (5-in-1) vaccine (DTaP-IPV-Hib) and the monovalent Hepatitis B vaccine to now be given in a single shot. According to Dr. Eun, since the introduction of Hexaxim into the NIP, there has been an increase in inquiries regarding new vaccination schedules and methods in actual clinical settings. Dr. Eun said, "With the introduction of the hexavalent vaccine, the vaccination schedule differs from the existing pentavalent vaccine, leading to many questions from both guardians and medical staff regarding vaccination criteria, interchangeability, and delayed vaccinations." Hexaxim is already a proven vaccine overseas, having received its first approval in Europe in 2013. It is now used in over 120 countries worldwide and is recommended as a mandatory vaccination in more than 40 countries, including Europe, Canada, and Australia. Dr. Eun explained, "The immunogenicity and safety of Hexaxim against all six infectious diseases through global clinical studies, including those conducted in Korea," and added, "In Korea, non-inferiority related to immunogenicity was confirmed through a clinical trial comparing the Hexaxim vaccination group with the group receiving the existing pentavalent DTaP combination vaccine concurrently with the monovalent Hepatitis B vaccine." Fewer injections due to schedule changes help improve convenience The introduction of Hexaxim has brought significant changes to the infant vaccination schedule. Previously, infants needed to receive the Hepatitis B vaccine at 0, 1, and 6 months of age and the pentavalent DTaP vaccine at 2, 4, and 6 months. However, starting this year, the schedule has changed. After the first Hepatitis B vaccination immediately after birth, infants will now receive Hexaxim at 2, 4, and 6 months, with no additional vaccination at 1 month. Dr. Eun stressed that "The introduction of Hexaxim reduces the total number of vaccinations by two, bringing the total to four injections." He added, "The hexavalent DTaP vaccine can administer six antigens at once, which can help improve vaccination rates compared to administering individual vaccines separately." However, as with any new vaccine introduction, there's some initial confusion in the field. Dr. Eun explained that there have been inquiries regarding the switching to the hexavalent vaccine at 6 months if the infant has already received the pentavalent combination vaccine at 2 or 4 months. The Korea Disease Control and Prevention Agency (KDCA) is addressing this confusion with clear guidelines. Dr. Eun stressed, "According to KDCA's official guidelines, DTaP-containing vaccines vary by manufacturer. Therefore, for the primary 3-dose series, it is recommended to administer vaccines from the same manufacturer consistently." Dr. Eun also said, "However, since most newborns are currently starting their vaccinations with Hexaxim, inquiries about interchangeability will gradually decrease in the future," and added, "There are also questions about vaccination age and intervals. Hexaxim's recommended vaccination schedule is at 2, 4, and 6 months of age (8-week intervals), with the recommended age for the first dose being 8 weeks (2 months of age)." However, in unavoidable circumstances, the first dose can be administered as early as 6 weeks of age. While a 2-month (8-week) interval is generally recommended, the vaccination schedule can be adjusted to a minimum of 4-week intervals. For example, if the first dose was given at 3 months of age, the second dose can be given 4 weeks later. Dr. Eun stated, "If there are any changes to the vaccination schedule, it is crucial to consult with a healthcare professional to get guidance on the timing and vaccine selection." There are, however, exceptional cases where Hexaxim cannot be administered. For instance, newborns born to mothers who are positive for the Hepatitis B virus must receive Hepatitis B immunoglobulin and the Hepatitis B vaccine within 12 hours of birth. These high-risk infants also require additional Hepatitis B vaccine doses at 1, 2, and 6 months of age, thus excluding them from the Hexaxim program. Furthermore, infants who have already completed their second Hepatitis B vaccination by 1 month of age cannot switch to Hexaxim and must continue their remaining vaccinations with the existing combination of the pentavalent vaccine and the Hepatitis B vaccine. "Hexaxim with increased preventive effects... high hopes for increasing vaccination rates" Dr. Eun stated that concerns about Hepatitis B antibody formation, which were previously raised by some, have been addressed through research. In the previous schedule, Hepatitis B vaccine was administered at 0 and 1 months of age. However, with the Hexaxim schedule, the 1-month vaccination is omitted, changing the schedule to 0-2-4~6 months. Regarding this, Dr. Eun responded, "The 0-2-4~6 month Hepatitis B vaccination schedule using Hexaxim showed immunogenicity similar to the existing 'pentavalent vaccine+Hepatitis B vaccine' schedule," and added, "Although the hexavalent vaccine includes a Hepatitis B component in addition to the existing pentavalent combination vaccine, its safety profile was confirmed to be similar to separate administrations." One of the anticipated effects of including Hexaxim in the NIP is an improvement in vaccination rates. Dr. Eun said, "Because a hexavalent vaccine can introduce six antigens in one shot, it can help improve vaccination rates compared to administering individual vaccines separately," and added, "Currently, infant primary vaccination rates exceed 90%, but we expect to push this figure higher with Hexaxim's introduction." As mentioned earlier, the reduced number of vaccinations helps prevent delayed vaccinations, which in turn can lead to a higher 'right-time vaccination rate,' thereby completing vaccinations at the recommended period, thus improving overall vaccination rates. Indeed, improvements in vaccination rates have been observed in other countries after the introduction of hexavalent combination vaccines. In Australia, after the hexavalent vaccine was included in their NIP, the vaccination rate for infants aged 12 months increased from 84.9% in 2009 to 92.6% in 2018. Lastly, Dr. Eun added, "Misinformation about vaccines can lead to a drop in vaccination rates, and previously well-managed infectious diseases could potentially re-emerge," and urged, "We hope the public would utilize the NIP to help protect children's health."
- Company
- Cream JAKi Delgocitinib to be commercialized in Korea
- by Eo, Yun-Ho Jun 20, 2025 06:06am
- JAK inhibitors will soon be available for hand eczema in Korea as well. The Ministry of Food and Drug Safety is currently conducting a final review of LEO Pharma Korea's treatment for moderate-to-severe chronic hand eczema (CHE), Anzupgo (delgocitinib). When approved, the drug is expected to be officially commercialized in the second half of the year in Korea. Anzupgo was officially approved in Europe in November last year and is currently awaiting approval from the US FDA. This cream formulation is known as a pan-JAK inhibitor, as it targets JAK1, 2, and 3, as well as TKY2. The efficacy of Anzupgo has been demonstrated through the DELTA FORCE and DELTA 2 clinical trials, which directly compared Anzupgo with GSK's alitretinoin (Toctino). In the DELTA FORCE study, the Hand Eczema Severity Index (HECSI) score from baseline to week 12 of delgocitinib demonstrated superiority over alitretinoin capsule, meeting the primary endpoint. The DELTA 2 study included 473 patients with moderate-to-severe chronic hand eczema (CHE). Study participants were assigned to either the delgocitinib cream group or the placebo cream group and received treatment twice daily for 16 weeks. The primary endpoint was set as an IGA-CHE score of 0/1 at Week 16 of treatment. The primary secondary endpoints included IGA-CHE and the Hand Eczema Symptom Diary (HESD) assessed at Weeks 4 and 8 of treatment. The results showed that the delgocitinib group achieved significant improvement in chronic hand eczema at Week 16 compared to the placebo group, meeting the primary and primary secondary endpoints. Chronic hand eczema can be triggered by various factors such as irritants, allergies, genetic predisposition, and occupational exposure. It often leads to recurring inflammation, peeling, cracking, and pain, significantly impacting daily life. However, to date, effective topical treatments specifically targeting hand eczema remain limited. In many cases, patients show insufficient response even to corticosteroids or immunosuppressants, underscoring the ongoing need for new therapeutic alternatives. Meanwhile, LEO Pharma obtained exclusive rights in 2014 from the Japanese company Japan Tobacco to develop and commercialize a topical delgocitinib cream for dermatological indications worldwide, excluding Japan.
- Company
- Interest in Lotte Biologcs’ partner Ottimo Pharma rises
- by Kim, Jin-Gu Jun 20, 2025 06:05am
- Interest is growing in Ottimo Pharma, a biotech company that has signed a contract manufacturing agreement for its antibody-drug with Lotte Biologics. Founded in 2017, this UK-based biotech venture owns a new drug candidate called ‘Jankistomig’. The drug candidate bifunctional antibody targeting solid tumors, and the company plans to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) within this year. Lotte Biologics announced on the 19th that it has signed an antibody-drug contract manufacturing agreement with Ottimo Pharma at the BIO INTERNATIONAL 2025 (Bio USA) event. The contract covers the production of drug substance (DS) for Ottimo Pharma's antibody drug Jankistomig at the Syracuse Bio Campus in New York. Ottimo Pharma was founded in 2017 in Kent, England, under the name Ultrahuman Eight Limited. In October last year, the company changed its name to Ottimo Pharma. At that time, Medicxi Ventures UK, a UK-based life science venture capital, participated as an initial investor. Medicxi led Ottimo Pharma's Series A investment round. Ottimo Pharma successfully secured USD 140 million (approximately KRW 190 billion) in Series A investment in December last year. To date, Ottimo Pharma’s only pipeline is Jankistomig. This candidate drug works by simultaneously inhibiting PD-1 and VEGFR2. The drug candidate was known to be designed based on camrelizumab, developed by China's Jiangsu Hengrui Pharmaceuticals. It is designed to reduce VEGF-related side effects while providing immune checkpoint inhibition effects. Jankistomig is in the preclinical stage and is being tested in the UK for solid tumors. There is no clinical trial number registered on ClinicalTrials.gov, a clinical trial registration site. This suggests that no official clinical trials have been initiated in any country, including the US and the UK. The company announced last year that it had secured Series A investment and would submit an Investigational New Drug (IND) application to the US FDA by the end of this year. At the time, Ottimo mentioned its development of other pipelines in addition to Jankistomig, but did not disclose specific substance names or stages.
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- New pneumococcal vaccine expected to be launched
- by Whang, byung-woo Jun 19, 2025 06:04am
- As 'Capvaxive,' a 21-valent pneumococcal conjugate vaccine (PCV21) developed by MSD, is anticipated to receive marketing authorization in South Korea, competition in the market is likely to heat up. Product photo of CapvaxiveAccording to pharmaceutical industry sources, MSD has filed with the Ministry of Food and Drug Safety (MFDS) for marketing authorization of Capvaxive. It is expected to be approved by the second half of 2025. Capvaxive is a vaccine designed to prevent adults from serotype that causes most of the invasive pneumococcal disease (IPD). The safety and immunogenicity of Capvaxive were cofirnmed based on the Phase 3 STRIDE clinical trial, comparing Capvaxive to PCV20 in adults aged 18 years and above who have no prior history of pneumococcal vaccination. Capvaxive was found to be nonequivalent to PCV20 regarding 10 serotypes (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F) that are commonly included in PCV20. 10 out of 11 serotypes (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B) that are included in Capvaxive but not in PCV20 were demonstrated to be superior to PCV20. Capvaxive was approved in the United States in June 2024 based on these study results, and it also obtained European approval in March. There is growing attention on whether Capvaxive will obtain Korean approval during the second half of this year, as it will be the third consecutive year a new pneumococcal vaccine is approved in South Korea. In late 2023, MSD's 15-valent vaccine, 'Vaxneuvance,' was expedited for inclusion in the pediatric National Immunization Program (NIP). Then, a year later, in October 2024, Pfizer's 20-valent vaccine, Prevenar 20, won MFDS approval. As the 21-valent vaccine, which is the higher serotype vaccine, is expected to be introduced in less than a year, competition is likely to get intense. If there are no setbacks to the approval process for Capvaxive, it is expected to be launched at the very end of the first half of next year. For instance, Vaxneuvance was launched in late April, and Prevenar 20 was launched in June exclusively for adults aged 18 years and above. The market is also highly likely to be competitive, with Vaxneuvance and Prevenar 20 competing for the pediatric NIP and Prevenar 20 and Capvaxive competing for the adult NIP. Regarding this, MSD Korea is expected to employ a marketing strategy that differentiates its vaccine portfolio for pediatric (15-valent) and adult (21-valent) populations. Indeed, MSD previously announced the use of tailored strategies for pediatric and adult populations during its Vaxneuvance launch 1st-anniversary media seminar. In the long term, Pfizer's Prevenar 20, with its first-mover advantage, will be competing directly with MSD's 21-valent Capvaxive, which includes a higher number of serotypes. Capvaxive will reportedly be preventing approximately 84-85% of adult IPD. This estimate is higher than the coverage for Prevenar 20. In this case, Pfizer is expected to defend its position by highlighting the performance and extensive clinical experience of Prevenar 20. Currently, Pfizer emphasizes that Prevenar 20 offers safety and convenience based on the well-established technology of Prevenar 13, validated through long-term pediatric and adult vaccinations, and with its 20-serotype coverage. Additionally, potential competition against Sanofi-SK bioscience is another variable. Although their commercialization timeline is the latest, if they succeed in developing a 21-valent vaccine, another equally strong competitor will emerge. Notably, the Sanofi vaccine is being developed for pediatric use, suggesting that the company will employ a future strategy to cover all age groups, from infants and young children to adults.
- Company
- K-Bios face string of clinical failures in H1
- by Son, Hyung Min Jun 19, 2025 06:04am
- A series of clinical trial failures for new drug candidates under development by Korean biotech companies in the first half of the year have raised concerns about the feasibility of future technology exports. Orum Therapeutics halted a clinical trial due to safety concerns, while Genexine and Bridge Biotherapeutics both failed to demonstrate statistical significance in their respective Phase II trials for glioblastoma and idiopathic pulmonary fibrosis. Stem cell therapy developers such as Anterogen and SCM LifeScience are also struggling to prove efficacy in clinical settings. According to industry sources on the 19th, Orum Therapeutics recently suspended its Phase 1 trial of ORM-5029. ORM-5029 was the company’s only pipeline in clinical trials targeting human epidermal growth factor receptor 2 (HER2), a major biomarker for solid tumors. The company received IND approval for ORM-5029 from the U.S. FDA in 2022. However, a severe adverse event (sAE) occurred during the trial, upon which the company reported it to the FDA. Due to toxicity issues, administration had to be halted even at low doses. ORM-5029 is a Degrader Antibody Conjugate (DAC) candidate. DACs combine Targeted Protein Degradation (TPD) mechanisms with Antibody Drug Conjugates (ADCs) and are expected to offer higher safety due to the use of TPD, which are small-molecule degraders. Orum emphasized that the sAE was limited to only the ORM-5029 substance and that there were no issues with the company's technology or platform itself. Orum plans to focus its resources on its blood cancer candidate ORM-1153, which also utilizes the company’s DAC platform. The company explained that it has shown strong GSPT1 degradation and robust anti-proliferative effects in blood cancer cell lines. Genexine and Bridge Biotherapeutics fail Phase II trials Genexine and Bridge Biotherapeutics both faced setbacks in Phase II trials. In March, Genexine's GX-I7 (Interleukin-7), an immune-oncology drug candidate, failed to demonstrate efficacy in glioblastoma mulifrome (GBM) patients. GX-I7 is a new drug candidate that maximizes immune anticancer effects by inducing T-cell amplification in the body. GBM is a type of glioma, a malignant tumor that originates in the brain. Despite surgery and chemotherapy, the five-year survival rate for GBM is only 5%, with an average survival time of about a year. The Phase II trial for GX-I7 enrolled 20 patients with recurrent or progressive glioblastoma, and evaluated a combination of the GX-I7 and bevacizumab (Avastin), a VEGF inhibitor used as a targeted therapy. Bevacizumab inhibits angiogenesis to prevent tumor growth, and its combination with existing anticancer drugs was expected to enhance therapeutic efficacy. However, no significant improvement was observed in the primary endpoints of progression-free survival (PFS) and overall survival (OS). Meanwhile, Bridge Biotherapeutics announced in April that its top-line data analysis results showed that its idiopathic pulmonary fibrosis (IPF) candidate BBT-877 failed to demonstrate a statistically significant improvement in the primary endpoint of forced vital capacity (FVC) change at 24 weeks. BBT-877 is an innovative novel drug candidate that selectively inhibits the novel target protein autotaxin. Autotaxin is a protein known to bind to intracellular receptors and be involved in pathological mechanisms such as fibrosis and tumorigenesis. BridgeBio previously secured global exclusive rights to BBT-877 from LegoChem Bio (now LigaChem Bio) in 2017. In May, BridgeBio received a recommendation from the IDMC to continue the clinical trial. The Phase 2 clinical trial of BBT-877 was conducted in 5 countries - South Korea, the United States, Australia, Poland, and Israel - to evaluate the efficacy, safety, and tolerability of the drug in patients with idiopathic pulmonary fibrosis (IPF). A total of 129 patients participated, and the study results showed that changes in FVC were observed in both the drug group and the placebo group; however, there was no statistically significant difference between the two groups. Bridge Biotherapeutics licensed out BBT-877 to Boehringer Ingelheim in 2019 in a deal worth up to KRW 1.5 trillion. Upon transferring BBT-877, which was in Phase 1 clinical trials, the company received approximately KRW 600 billion in upfront and milestone payments (short-term milestones). In late 2019, following the completion of Phase I clinical trials for BBT-877, BridgeBio paid approximately KRW 50 billion to LigaChem Bio as milestone revenue sharing. However, in 2020, Boehringer Ingelheim returned the rights to BBT-877 due to potential toxicity issues. BridgeBio determined that the toxicity issues were caused by high-dose drug administration in additional experiments and decided to develop the candidate on its own, but failed to demonstrate its efficacy in trials. stem cell therapy developers also struggling with commercialization Stem cell therapy developers are also facing commercialization hurdles. SCM LifeScience failed to achieve statistical significance in Phase 2 clinical trials of its stem cell therapy candidate SCM-CGH. This is the company's second failed attempt at commercialization following the failure of its acute pancreatitis clinical trial in 2022. The trial, which targeted patients with steroid-resistant or steroid-dependent chronic graft-versus-host disease, was conducted from 2017 to 2024 at 11 hospitals in South Korea, including Seoul St. Mary's Hospital. The results of the Phase II clinical trial of SCM-CGH showed no statistically significant difference in the primary efficacy endpoint, the overall response rate (ORR) at 12 weeks. Upon closer examination, the ORR at 12 weeks was higher in the placebo group than in the SCM-CGH group, and the results were not statistically significant. Anterogen failed to demonstrate the efficacy of its stem cell therapy ALLO-ASC-DFU in the U.S. Phase III clinical trial. In the trial, ALLO-ASC-DFU recorded a complete wound closure rate of 46%, which was lower than the 60% in the control group that was treated with hydrogel sheets. The therapy had garnered attention as a treatment for diabetic foot ulcers (DFU), but its failure to meet the key primary endpoint has significantly reduced the likelihood of its FDA approval. Anterogen is conducting further analyses to revise its development strategy.
