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- 2026-03-10 22:25:30
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- Pfizer launches 'Prevenar 20' for adults aged 18 years+
- by Whang, byung-woo Jun 11, 2025 06:01am
- Product photo of Prevenar 20 Pfizer Korea (CEO and President Dong-wook Oh) announced on June 10 that its 'Prevenar 20,' a 20-valent pneumococcal conjugate vaccine for adults, was launched in early June, and it is now available for vaccination for individuals aged 18 years and older. Prevenar 20 will be supplied to the Korean market for adults through a co-promotion and distribution partnership between Pfizer Korea and Chong Kun Dang. The two companies have maintained a partnership since their initial domestic distribution agreement for Prevenar 13 in 2017. Through this new partnership for Prevenar 20, they aim to strengthen their position in the adult vaccine market and continue efforts to enhance vaccine accessibility. Prevenar 20 is a pneumococcal conjugate vaccine that was approved by the Ministry of Food and Drug Safety (MFDS) on October 31, 2024. Compared to the 13-valent vaccine, Prevenar 20 has added seven additional pneumococcal serotypes. Among domestically approved pneumococcal conjugate vaccines, it contains the most serotypes (as of 10/31/2024). It can be used for preventing invasive pneumococcal disease and pneumonia caused by pneumococcus in all ages postnatal 6 weeks or above (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F). The Korean Society of Infectious Diseases (KSID) has recently announced new recommendations for the pneumococcal conjugate vaccine as part of its revised 2025 guidelines for adult vaccination. KSID's adult immunization board has recommended sequential vaccination with PCV20 or PCV15, followed by PPSV23, for adults aged 65 and older and for high-risk individuals aged 19-64. This high-risk group includes patients with chronic diseases, cerebrospinal fluid leakage or cochlear implants, immunocompromised patients, and individuals with functional or anatomical asplenia. Chan-woo Song, Vice President of the Primary Care Business Unit at Pfizer Korea, said, "We are delighted to further strengthen our long-standing partnership with Chong Kun Dang through this co-promotion and distribution partnership for Prevenar 20." He added, "This collaboration between our two companies has expanded the opportunity for Prevenar 20 to be made available to more adults." Young-Joo Kim, CEO of Chong Kun Dang, said, "Based on the partnership that began with Prevenar 13, we find it meaningful to be able to supply the newly launched adult Prevenar 20 in Korea," and added, "Both companies will continue to collaborate to contribute to the development of the domestic vaccine market and strive to provide a healthier future for more patients." Meanwhile, the safety, tolerability, and immunogenicity of Prevenar 20 were confirmed through global clinical trials. In the United States and Sweden, 3,902 adults aged 18 and older who had no prior pneumococcal vaccine history were divided into three age groups: 18-49 years, 50-59 years, and 60 years or older. Individuals aged 60 and above received either Prevenar 20 or PCV13+PPSV23, while those aged 18-59 received either Prevenar 20 or PCV13. Based on the primary immunogenicity endpoint, which was OPA GMT in adults aged 60 and older, Prevenar 20's non-inferiority was confirmed for the 13 serotypes shared with Prevenar 13. Non-inferiority was also confirmed for 6 out of the seven additional serotypes compared to PPSV23. Furthermore, the frequency and severity of local and systemic reactions occurring within 10 days after vaccination with Prevenar 20 or PCV13 were similar.
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- "Atopic dermatitis treatment…personalized trt. is the key"
- by Whang, byung-woo Jun 11, 2025 06:01am
- "Significant changes are being brought to atopic dermatitis treatment. which can be described as a 'major shift.' As it is a complex disease with various factors involved, establishing criteria for personalized treatment regarding which therapeutic agent to use for each patient is necessary." Atopic dermatitis is one of diseases whose treatment landscape has undergone significant changes in recent years. As atopic dermatitis is a chronic skin condition with complex etiologies, its treatment has historically been challenging. However, the recent emergence of various novel drugs, such as biologics and JAK inhibitors, has diversified treatment options. During a meeting with Daily Pharm, Dr. Ga-Young Lee, a Professor at Kangbuk Samsung Hospital's Department of Dermatology, stressed the necessity of personalized treatment options for advancing the treatment environment of atopic dermatitis. "Introduction of new atopic dermatitis drugs offers hope to patients who gave up on treatment due to side effects" Atopic dermatitis is a chronic skin inflammation caused by a complex interplay of genetic factors, immune dysfunction, and impaired skin barrier function. Professor Ga-Young Lee at Kangbuk Samsung HospitalNotably, the quality of life issue for patients with severe atopic dermatitis is particularly acute. Because the disease affects the whole body, patients experience severe itching and pain, leading to sleep disturbances and psychological stress, which significantly disrupt their daily lives. In this context, the shift of the atopic dermatitis treatment landscape with the advent of new drugs is assessed as offering hope to patients. Dr. Lee explained, "With the emergence of various new drugs, such as biologics and JAK inhibitors, patients who were previously neglected due to side effects from steroid treatments or treatment abandonment are now returning to the hospital," and Dr. Lee added, "Now, diverse treatment options are available, enabling personalized treatment tailored to each patient's condition and needs." Biologics and JAK inhibitors are two main pillars of atopic dermatitis treatment, with the choice of therapy being made based on patient severity, treatment speed, side effects, and economic burden. Dr. Lee said, "It's difficult to decide on a single approach, but strategies can vary depending on the patient's severity." Dr. Lee noted, "For severe patients with extensive systemic involvement, injectables are primarily considered, but for those requiring rapid treatment, JAK inhibitors might be more suitable." For severe patients with an EASI score of 30 or higher and extensive systemic involvement, injectables such as dupilumab or tralokinumab are used. For cases requiring rapid treatment, JAK inhibitors like Cibinqo (abrocitinib) are an option. Indeed, Cibinqo has shown a rapid onset of action (the time it takes to see treatment effects) in clinical studies. In the JADE MONO-2 study, 200mg monotherapy demonstrated significantly greater itch improvement compared to placebo within 24 hours of the first dose. The JADE MONO-1 study also demonstrated significant improvement in skin symptoms by week 12 compared to the placebo. "There are patients who say their symptoms improved significantly within a week or even the very next day after taking Cibinqo, which highlights its fast onset," Dr. Lee stated. "This advantage makes Cibinqo a consideration for those who need quick relief or young adults entering the workforce." Dr. Lee also said, "Cibinqo showed good efficacy even in cases where symptoms were confined to the face and neck. While there are concerns about herpes as a side effect of JAK inhibitors, Cibinqo has shown relatively fewer side effects, making it safe." She added, "Considering that drug price is also an important factor, the availability of various dosages is a strength of Cibinqo." Currently, Cibinqo offers three dosage options: 50mg, 100mg, and 200mg, allowing for adjustment based on weight or condition. Dr. Lee explained that patients whose condition is controlled with 200mg can gradually reduce their dosage to 100mg or 50mg. "For patients with impaired kidney function, even if severe, it's difficult to use high doses, so sometimes only 50mg is prescribed. For lighter female patients or adolescents, high doses may be unnecessary," Dr. Lee said. "In such cases, treatment can be started with 100mg and adjusted down to 50mg. Therefore, having three dosage options is a significant advantage, as it allows for personalized patient treatment." "Reimbursement criteria of atopic dermatitis has a limitation, expanded criteria for rapid treatment is necessary" Another change concerning atopic dermatitis treatment is the approval of inter-class switching between biologics and JAK inhibitors. Regarding this, Dr. Lee advised that inter-class switching (between therapeutic regimens) is necessary to ensure treatment flexibility. Dr. Lee stated, "The current reimbursement criteria for switching therapies only allow coverage when switching between biologics and JAK inhibitors, which doesn't align with clinical practices," and explained, "There are patients who need to switch from biologics to JAK inhibitors, and conversely, there are cases where switching from JAK inhibitors to biologics is necessary." Especially with the emergence of new atopic dermatitis drugs, personalized treatment should be possible. However, as data have not yet fully accumulated, some consider that improvements are needed to allow for trying and switching to therapies within the same class but with different targets and effects. "In recent meetings with overseas medical professionals, issues related to switching therapies were raised, and no other country had as restrictive criteria as Korea," Dr. Lee said. "While there may be limitations within Korea's national health insurance system, in my opinion, I believe there needs to be a greater variety of options for drug switching." Dr. Lee also pointed out that the 'special cases criteria' for atopic dermatitis are excessively stringent compared to conditions like psoriasis. Dr. Lee stated, "For psoriasis, reimbursement is approved if there's no effect even after 3 months of treatment, but for atopic dermatitis, 'special cases criteria' is only possible for severe patients with an EASI score of 23 or higher," and suggested, "If 'special cases criteria' are applied only to severe patients with a 10% co-payment, mild or moderate patients don't receive treatment benefits. The system should be improved to allow partial reimbursement support for moderate patients as well." Additionally, Dr. Lee emphasized the need for systematically established treatment guidelines tailored to patient conditions, mentioning the necessity of clear treatment criteria and personalized guidance, including biomarkers and lesion location. Finally, Dr. Lee stressed, "While the atopic dermatitis treatment landscape is rapidly advancing, continuous management and treatment are currently the main focus rather than a complete cure." Dr. Lee concluded, "With specialized medical professionals, it's important to maintain and improve the patient's quality of life continuously."
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- Polycythemia vera drug 'Besremi' nearing end of reimb review
- by Eo, Yun-Ho Jun 10, 2025 06:04am
- PharmaEssentia Korea The polycythemia vera (PV) treatment 'Besremi' has entered the final stage of an insurance reimbursement review process. The Ministry of Health and Welfare (MOHW) has recently ordered the National Health Insurance Service (NHIS) to initiate drug price negotiation for PharmaEssentia Korea's Besremi (ropeginterferon alfa-2b). If the company succeeds in negotiation, the drug will be approved for reimbursement in the second half of this year. It is to be watched whether Besremi will be successful in its second attempt. The company underwent the reimbursement process in March 2023 for the treatment of hydroxyurea-refractory/resistant polycythemia vera. However, Besremi did not overcome the Cancer Disease Review Committee (CDRC) hurdle. At the time, the CDRC determined that Besremi lacked evidence for clinical utility as a second-line treatment. After that, PharmaEssentia added Besremi's domestic clinical documents, supplemented efficacy evidence as a second-line treatment, and re-submitted the reimbursement application in March last year. In the same year, it passed the CDRC in July. It passed the review by the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) last month. Besremi is a next-generation interferon designed to selectively eliminate Janus kinase 2 (JAK2) gene, which causes polycythemia vera. With the improvement made to purity and tolerability of the previous interferon agents, this drug was designed to be taken once every 2 weeks for the initial 1.5 years, then once every 4 weeks. Besremi is now recommended by the National Comprehensive Cancer Network (NCCN) and the European LeukemiaNet (ELN) as treatment for polycythemia vera regardless of previous therapy history. Meanwhile, polycythemia vera is a rare blood cancer where somatic cell mutation in bone marrow causes abnormal activation of bone marrow function, resulting in the overproduction of red blood cells. According to the HIRA documents, the number of patients in Korea with the disease is about 5,000, and hydroxyurea is used in most patients. However, polycythemia vera is a disease with high unmet needs because the current drugs that are covered by reimbursement cannot treat the underlying causes of the disease, and no alternative treatment options exist when patients fail hydroxyurea treatment.
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- Celltrion’s Stelara biosimilar Qoyvolma gains EU approval
- by Kim, Jin-Gu Jun 10, 2025 06:03am
- Celltrion announced on the 9th that ‘Qoyvolma,’ its biosimilar version of the autoimmune disease treatment Stelara (ustekinumab) has received marketing authorization from the European Commission (EC). Qoyvolma has been approved with the addition of ▲'ulcerative colitis (UC)' to the existing indications of ‘Steqeyma,' another Stelara biosimilar previously approved by Celltrion, which is indicated for ▲plaque psoriasis, ▲psoriatic arthritis, and ▲Crohn's disease (CD). With this approval, Celltrion now holds two biosimilars of Stelara. Celltrion plans to strategically leverage the two products with different indications to flexibly address the complex patent landscape across European countries and expand its market share. The company expects that the addition of Qoyvolma will enhance its competitiveness in the ustekinumab market by expanding indications, as Steqeyma’s sales have been growing rapidly in Europe upon its launch. Steqeyma is a new biosimilar treatment that was released in Europe and the US in November last year and March this year, respectively. In Europe, it has been launched in five major countries (Germany, Spain, the UK, Italy, and France) as well as the Netherlands, and has already secured bids in tenders, marking the beginning of its market penetration. In the US, it has signed contracts with two of the top five prescription drug reimbursement management companies (PBMs), which account for about 90% of the total insurance market, and is in negotiations with other PBMs. Celltrion plans to continue expanding its market share in the global ustekinumab market to drive sales growth. According to IQVIA, a pharmaceutical market research firm, the global market size for ustekinumab is estimated to be approximately USD 21.66 billion (approximately KRW 30.32 trillion) as of 2024. A Celltrion official stated, “With the recent approval of Qoyvolma, we will be able to further strengthen our coverage of the ustekinumab market in Europe. Given that Steqeyma, which was launched earlier, is already showing positive growth trends in the global ustekinumab market including Europe, we will make every effort to leverage the complementary strengths of both products to expand market share and drive sales growth.”
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- Next-gen oral breast cancer drugs near commercialization
- by Son, Hyung Min Jun 09, 2025 05:53am
- The arrival of next-generation oral selective estrogen receptor degraders (SERDs) is imminent. At the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 which was held in Chicago, USA, from the 30th of last month to the 4th, multinational pharmaceutical companies simultaneously disclosed the results of their Phase III clinical trials for their oral SERD candidates. At this conference, Pfizer's vepdegestrant and AstraZeneca's camizestrant both presented positive research results. SERDs are primarily used as a treatment option for patients with breast cancer who are resistant to endocrine therapy. Until now, AstraZeneca's Faslodex, an injectable drug, had been the main option. Following this, Menarini's 'Orserdu' emerged as the first oral SERD option, and Lilly completed clinical trials for ‘Inluriyo ‘and submitted an application for its regulatory approval. If latecomers Pfizer and AstraZeneca both succeed in commercializing their products, it is expected that the SERD market will see greater utilization of oral treatment options. #Oral SERD using PROTAC technology… green light lit to its commercialization AstraZeneca announced at the conference that the combination therapy of camizestrant and CDK4/6 inhibitors demonstrated statistically significant improvements in progression-free survival (PFS). Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are treatment options for patients with hormone receptor (HR)-positive, HER2-negative breast cancer. Representative CDK4/6 inhibitors include Pfizer's Ibrance, Lilly's Verzenio, and Novartis's Kisqali. Camizestrant applies Proteolysis-targeting chimera (PROTAC) technology to targeted protein degradation (TPD) drugs. TPD is a next-generation drug candidate that harnesses the cell’s own protein degradation system to selectively eliminate target proteins. While traditional small molecule drugs inhibit protein function, TPD drugs are known to offer superior therapeutic effects without resistance issues because they fundamentally degrade and eliminate the disease-causing proteins. TPD drugs have the advantage of being able to target over 80% of disease-causing proteins that conventional small-molecule compounds cannot regulate. The Phase III SERENA-6 trial evaluated the efficacy of maintaining the standard treatment regimen of aromatase inhibitors (anastrozole or letrozole) combined with CDK4/6 inhibitors or switching to camizestrant combination therapy in patients with HR-positive, HER2-negative advanced breast cancer who developed ESR1 mutations during first-line therapy. According to the investigator assessment, the camizestrant combination therapy reduced the risk of disease progression or death by 56% compared with standard therapy. The median progression-free survival (PFS) in the camizestrant combination therapy group was 16.0 months, significantly longer than the 9.2 months in the standard therapy group. This improvement in PFS was consistent across various subgroups, including age, race, region, and the timing of ESR1 mutation detection and type. Additionally, the camizestrant combination therapy was shown to significantly delay the onset of deterioration in quality of life. According to exploratory analysis, the camizestrant combination therapy reduced the risk of deterioration in quality of life (global health status/QOL) by 47% compared to the aromatase inhibitors (AI) combination therapy. At the time of this interim analysis, data on key secondary endpoints—including time from randomization to second disease progression or death (PFS2) and overall survival (OS)—were not yet mature. However, the camizestrant combination therapy showed a trend toward prolonged treatment benefits based on PFS2. The clinical trial will continue to evaluate OS, PFS2, and other key secondary endpoints in the future. Presentation of SERENA-6 trial results at ASCO 2025 (Source: AZ). Pfizer announced the results of its Phase III VERITAC-2 study of ‘vepdegestrant,' an oral SERD drug candidate developed in collaboration with Arvinas. Pfizer acquired Arvinas' pipeline in 2021 and is currently conducting joint research. Arvinas' platform PROTAC (PROTAC) was, for a period, widely regarded as synonymous with TPD technology. The VERITAC-2 study is a Phase III clinical trial evaluating the efficacy of vepdegestrant in 624 patients with estrogen receptor (ER)+/HER2- advanced or metastatic breast cancer who have progressed on CDK4/6 inhibitors and endocrine therapy. Patients were randomly assigned to the vepdegestrant or Faslodex group in a 1:1 ratio. The primary endpoint was PFS, assessed by blinded independent central review (BICR) in patients with estrogen receptor 1 mutation (ESR1m) and all patients. Overall survival (OS) was a key secondary endpoint. Clinical trial results showed that the median PFS in the ESR1 mutation patient group treated with vepdegestrant was 5.0 months, compared to 2.1 months in the Faslodex group. The vepdegestrant group showed a reduction in disease progression or death by 43%. The most common treatment-emergent adverse events (TEAEs) in the vepdegestrant group were fatigue (15.6%), increased ALT (9.8%), increased AST (10.4%), and nausea (8.8%). However, all these rates were lower than those in the Faslodex group. The research team evaluated, “Vepdegestrant demonstrated overall good tolerability, with a low discontinuation rate due to adverse events. These results support vepdegestrant’s potential as an oral treatment option for patients with previously treated ER+/HER2- advanced or metastatic breast cancer.
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- K-Bio unveils new cancer drug outcomes at the ASCO meeting
- by Son, Hyung Min Jun 09, 2025 05:53am
- The Korean pharmaceutical and biotech industry has unveiled additional clinical outcomes of drug candidates, such as immunotherapy for cancer, targeted anticancer agents, and bispecific antibodies, under development. Major Korean companies, including Daewha Pharmaceutical, LG Chem, Onconic Therapeutics, ImmuneOncia, and Tium Bio, unveiled their trial results of new anticancer drugs at the American Society of Clinical Oncology (ASCO 2025) annual meeting, which started on May 30 and lasted 4 days in Chicago, U.S. 'FOTIVDA' monotherapy is more effective than Optivo combination therapy LG Chem, through its U.S.-based subsidiary AVEO Oncology ("AVEO"), unveiled the results of the Phase 3 TiNivo-2 study evaluating 'FOTIVDA' monotherapy. Anticancer drug FOTIVDAAVEO received approval for FOTIVDA from the European Medicines Agency (EMA) in 2017 and the U.S. Food and Drug Administration (FDA) in 2021. LG Chem acquired AVEO for $571 million (approximately KRW 700 billion) in 2022. In the previous TiNivo-2 clinical trial, which assessed the clinical possibility of combination therapy, the FOTIVDA + Opdivo combination failed to show improved progression-free survival (PFS) compared to FOTIVDA monotherapy. The latest analysis is a follow-up result from the second-line treatment setting. It evaluated the potential of FOTIVDA monotherapy in 153 patients with renal cell carcinoma who had failed prior treatment with Opdivo+Yervoy or a VEGFR (vascular endothelial growth factor receptor) targeted therapy+immunotherapy combination. Patients were randomly assigned in a 1:1 ratio to either the FOTIVDA monotherapy group or the FOTIVDA + Opdivo group. Clinical results showed that in the Opdivo+Yervoy failure group, the PFS for FOTIVDA monotherapy was 9.2 months, which is similar to the 9.3 months observed for the FOTIVDA+Opdivo group. The objective response rate (ORR) was higher for FOTIVDA monotherapy at 32.4%, compared to 24.2% for the FOTIVDA+Opdivo group. Differences were more pronounced in the patient group that had failed prior VEGF targeted therapy+immunotherapy. In this group, the PFS for FOTIVDA monotherapy was 7.4 months, which was 2.5 months longer than the 3.9 months for the combination group. ORR was recorded at 22.0% for the monotherapy group and 9.5% for the combination therapy group. The researchers stated, "Subgroup analysis of the TiNivo-2 study showed that FOTIVDA monotherapy demonstrated greater efficacy than FOTIVDA + Opdivo. The addition of Opdivo to FOTIVDA did not show a significant benefit, consistent with previous clinical results." Daehwa Pharmaceutical unveils oral paclitaxel Phase 3 clinical trial results Daewha PharmaceuticalDaehwa Pharmaceutical has unveiled the results of a multinational Phase 3 clinical trial for Liporaxel, an improved oral formulation of the injectable anti-cancer drug paclitaxel. Liporaxel is a modified new drug that converts injectable paclitaxel into an oral formulation through Daehwa's proprietary lipid-based DHLASED platform technology. Liporaxel's strength is its convenience of administration. Paclitaxel, an intravenous (IV) formulation and a first-generation cytotoxic anticancer drug, is known for its long administration time and various side effects, such as vomiting, nausea, and hair loss. In clinical trials, Liporaxel demonstrated improvements in side effects, such as hair loss and peripheral neuropathy, compared to the paclitaxel IV formulation. Being free from infusion-related side effects is also a key strength of Liporaxel. The recently disclosed Phase 3 clinical study aimed to prove the non-inferiority of Liporaxel compared to injectable paclitaxel in 549 patients with metastatic breast cancer. Clinical results showed that Liporaxel achieved a median PFS of 10.02 months, demonstrating non-inferiority compared to injectable paclitaxel's 8.45 months. Overall survival (OS) was similar, with Liporaxel at 32.95 months and injectable paclitaxel at 32.46 months. ORR and disease control rate (DCR) were higher in the Liporaxel group. In terms of safety, Liporaxel showed a lower occurrence rate of peripheral neuropathy, hypersensitivity reactions, musculoskeletal and connective tissue disorders, and infusion-related reactions compared to injectable paclitaxel. The researchers emphasized, "Liporaxel demonstrated equivalent efficacy to injectable paclitaxel, along with good tolerability and manageable toxicity. These results indicate that Liporaxel is an effective and convenient alternative to injectable paclitaxel for patients with HER2-negative metastatic breast cancer." Major biotech companies unveil immunotherapy·targeted anticancer drug clinical outcomes ASCO 2025 site (source=ASCO).TiumBio presented the results of its Phase 2 clinical trial of combination therapy containing 'TU2218,' an immunotherapy candidate, in combination with MSD's immunotherapy Keytruda. TU2218 simultaneously blocks the pathways of transforming growth factor-beta (TGF-ß) and vascular endothelial growth factor (VEGF), which are known to inhibit immunotherapy activity. This mechanism aims to maximize the efficacy of immunotherapies. The recently disclosed trial represents early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer. Clinical results showed that the TU2218+Keytruda combination therapy resulted in a partial response (PR) in 7 out of 11 patients with head and neck cancer, with stable disease (SD) observed in 1 patient. In the biliary tract cancer cohort, 4 out of 23 patients achieved a PR and 7 showed SD. Onconic Therapeutics shared updates on two ongoing clinical trials for 'Nesuparib,' a targeted anticancer drug under development, at this conference. Nesuparib is a new drug candidate with a dual mechanism that simultaneously inhibits poly ADP-ribose polymerase (PARP) and Tankyrase. Onconic Therapeutics unveiled progress from its Phase 1b clinical trial in metastatic pancreatic cancer. This multicenter, open-label, Phase 1b dose-finding study is recruiting up to 48 patients with locally advanced or metastatic pancreatic cancer. The trial is divided into Group A Nesuparib+FOLFIRI therapy (oxaliplatin, leucovorin, irinotecan, fluorouracil) and Group B Nesuparib+gemcitabine+albumin-bound paclitaxel. The primary objectives of the trial are to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to identify the optimal combination therapy based on safety. The Phase 1 trial is being conducted. Additionally, Onconic Therapeutics is also confirming the potential of Nesuparib in recurrent endometrial cancer. The clinical study, named PENELOPE, is being conducted to verify whether adding Nesuparib to Keytruda maintenance therapy improves PFS after treatment with paclitaxel+carboplatin+Keytruda. Patient enrollment began in the fourth quarter of last year. ImmuneOncia revealed clinical outcomes for its immunotherapy candidate IMC-002. IMC-002 works by blocking the signals between CD47 on cancer cells and macrophages. The results disclosed are preliminary findings from an ongoing Phase 1b clinical trial in patients with hepatocellular carcinoma. The trial is evaluating the tolerability and safety of IMC-002 in combination with Lenvima, which is used to treat hepatocellular carcinoma. Among 10 evaluable patients, the ORR was 30%, and the DCR was 70%. The median time to progression (TTP) was 8.3 months. The researchers said, "The efficacy and a safety profile were confirmed when IMC-002 20mg/kg in combination with Lenvima was administered every 3 weeks."
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- 1st patient enrolled in Phase 2 FDA trial of 'Nugel' in KOR
- by Lee, Seok-Jun Jun 09, 2025 05:51am
- Shaperon announced on June 5 that a Phase 2 Part 2 U.S. Food and Drug Administration (FDA) clinical trial for its atopic dermatitis drug 'Nugel' has enrolled the first patient for clinical trials being conducted in South Korea. This trial is a multinational clinical trial evaluating Nugel's safety and efficacy in 177 patients across 12 clinical sites in South Korea and the United States. In South Korea, the first meetings for initiating the clinical trial have been recently completed at major hospitals, including △ Seoul National University △ Seoul National University Bundang Hospital. The first patient was enrolled at Seoul National University Bundang Hospital. Shaperon representative said, "Researchers involved in Korean clinical trials are anticipating significant results from Part 2 clinical trial, based on superior data confirmed in Part 1 clinical trial. In the United States, patients have been recruited since March, and so far, over 40 patients have completed registration. Shaperon aims to secure the final clinical result report and plans to finish drug administration in all patients within the first half of next year. 'Nugel,' developed by Shaperon, is a first-in-class medicine for atopic dermatitis. Superior safety and continuous anti-inflammatory effects are expected compared to existing treatments. In the Phase 2 Part 1 FDA clinical trial, Nugel demonstrated superior efficacy and higher safety compared to a placebo. Furthermore, this drug recorded superior results in terms of primary endpoints, which are 'EASI50' and 'IGA-TS,' compared to existing treatments.
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- GC’s US affiliate Curevo extends shingles vaccine trial
- by Cha, Jihyun Jun 09, 2025 05:50am
- GC Biopharma (CEO Eun-Chul Huh) announced on the 4th that its U.S. affiliate Curevo Vaccine has completed the enrollment of its first patient in the Phase 2 extension study of its shingles vaccine amezosvatein. This clinical trial was designed based on the results of the previously conducted Phase II trial. The extension trial will serve as a step toward determining the optimal dose prior to entering Phase III clinical trials, and the company explained that the study incorporates feedback from regulatory authorities and key stakeholders. The Phase 2 extension includes the key population of adults over age 50, targeting randomization of 640 participants to receive amezosvatein or Shingrix, the currently approved shingles vaccine. The company stated, “The inclusion of the key population of adults aged 70 and older holds significance in securing efficacy and safety data for the vaccine in the elderly population.” “I’m so proud of the Curevo team’s drive to get amezosvatein to people looking for a shingles vaccine alternative,” stated Dr. Guy De La Rosa, Chief Medical Officer for Curevo. “We are also proud to be working with a great collection of clinical trial sites, whose excitement for this trial and the overall potential of amezosvatein is gratifying.” “To enroll our first patients just over two months after announcing our $110 million Series B round demonstrates the Curevo team’s ability to execute quickly,” added George Simeon, Curevo’s CEO. Curevo plans to accelerate the entry of amezosvatein into Phase III clinical trials, as well as its commercialization and global approval strategies. Curevo is a vaccine-specialized subsidiary established in 2018 by GC Biopharma in Seattle, Washington, USA. As of the end of last year, GC Biopharma held a 78% stake in the company. Curevo secured a total investment of USD 60 million in its Series A funding round in 2022 and completed its Series B round in March this year with an investment of USD 110 million.
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- 'Vonjo' for myelofibrosis expected to be marketed in KOR
- by Eo, Yun-Ho Jun 05, 2025 06:11am
- Product photo of Vonjo The oral myelofibrosis treatment 'Vonjo' is expected to be commercialized in Korea. According to industry sources, the Ministry of Food and Drug Safety is conducting an approval review of Vonjo (pacritinib). This drug obtained orphan drug designation (ODD) in September of last year. Vonjo is indicated for 'treatment of intermediate-risk or high-risk adult patients with myelofibrosis who have plate count below 50×10⁹/L.' Vonjo is regarded as a competitor of Novartis' 'Jakabi (ruxolitinib)' and it obtained accelerated approval from the U.S. Food and Drug Administration (FDA) in 2022. It is a novel oral kinase inhibitor that does not inhibit Janus kinase 1 (JAK1 )but instead inhibits JAK2 and IRAK1. The efficacy of Vonjo, developed by CTI BioPharma, was confirmed through the Phase 3 PERSIST-2 study. In the study, patients were provided with either twice-daily 200 mg Vonjo or once-daily or the existing best available therapy (BAT). The study participants included those who had previously used JAK2 inhibitors. The study showed that 29% of the patient group who had platelet counts below 50×10⁹/L at the beginning of the trial then took twice-daily 200 mg Vonjo had at least 35% reduction in spleen volume. The control group had a reduction rate of 3%. Meanwhile, myelofibrosis induces broad scarring in the bone marrow and suppresses hematopoiesis, ultimately causing platelet count reduction·anemia·weakness·tiredness·liver, and spleen edema. Previously, only 3% of patients who received conventional therapy targeting myelofibrosis experienced a treatment effect of spleen volume reduction. Myelofibrosis previously lacked second-line treatment options besides Jakabi in Korea. BMS' 'Inrebic (fedratinib)' was recently introduced. Insurance reimbursement has been applied since June of last year.
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- Global pharmas race to introduce bispecific antibodies
- by Son, Hyung Min Jun 05, 2025 06:10am
- Major global pharmaceutical companies are challenging the throne held by the immunotherapy Keytruda with their respective bispecific antibodies. Recently, BMS signed a partnership agreement with Germany's BioNTech to develop a new bispecific antibody, while Pfizer successfully introduced a bispecific antibody from China's 3SBio last month. MSD also secured bispecific antibodies from a Chinese pharmaceutical company in preparation for the post-Keytruda era. According to data released by KoreaBIO on the 4th, BMS recently secured the development rights for BioNTech's bispecific antibody candidate “BNT327.” Under the agreement, BMS will pay BioNTech a contract fee of USD 1.5 billion (approximately KRW 2 trillion) and an additional USD 2 billion in unconditional milestone payments by 2028. The total deal value, including milestones and the upfront payment, amounts to USD 11.1 billion (approximately KRW 15.3 trillion). MSDBNT327 is a new bispecific antibody that combines two complementary mechanisms of action proven in oncology into a single molecule. This new drug candidate targets both PD-1, the biomarker targeted by the existing Keytruda, and vascular endothelial growth factor (VEGF)-A. By inhibiting VEGF-A, BNT327 is expected to reverse the immune-suppressive effects of tumors in the tumor microenvironment and block the supply of blood and oxygen to tumor cells, thereby preventing tumor growth and proliferation. BNT327 is currently being developed as a first-line treatment for small cell lung cancer and non-small cell lung cancer. According to BioNTech, more than 1,000 clinical trial patients have been treated with the drug to date. BioNTech said in a statement, “Our major global partners are working to set new treatment standards in the anticancer drug market dominated by immunotherapies like Keytruda.” Pfizer also signed a partnership agreement with China's 3Sbio last month to secure SSGJ-707, a bispecific antibody candidate targeting PD-1 and VEGF-A. The upfront payment is USD 1.25 billion, with the total contract value reaching USD 4.8 billion (KRW 6.6 trillion) upon achievement of key milestones. Currently, SSGJ-707 is under clinical trials in China targeting various solid tumors, including non-small cell lung cancer, colorectal cancer, and gynecological cancers. MSD, the developer of Keytruda, has also secured a PD-1 and VEGF-A bispecific antibody candidate. Last November, MSD acquired the new drug candidate LM-299 from China's LaNova Medicine for up to USD 3.3 billion. The contract price was USD 588 million. LM-299 is currently under Phase I clinical trial in China. Will competition intensify for the global sales lead Keytruda? Major global pharmaceutical companies are targeting the market for Keytruda, the global No.1 top-selling drug. Last year, Keytruda's sales reached USD 29.482 billion (approximately KRW 43 trillion), an 18% increase from 2023. Last year, the total sales of major immunotherapy drugs amounted to USD 51.723 billion (approximately KRW 75 trillion), with Keytruda holding 57% of the market share. Keytruda first surpassed USD 10 billion in sales in 2019 and continued to grow, reaching USD 20.937 billion in 2022, successfully breaking the USD 20 billion mark for the first time. Immunotherapies like Keytruda target the PD-1/PD-L1 biomarker expressed in major solid tumors. As a result, their indications are being expanded to various types of solid tumors, leading to a surge in sales. In addition to their efficacy, immunotherapies have the advantage of having fewer side effects. Compared to first-generation cytotoxic anticancer drugs and second-generation targeted anticancer drugs, cancer immunotherapies are known to have fewer side effects. These drugs reinforce the body's own immune system to achieve anticancer effects, resulting in relatively mild side effects such as hair loss, nausea, vomiting, diarrhea, and bone marrow suppression. The industry attributes the growth in Keytruda’s sales to the expansion of indications for Keytruda and its demonstrated efficacy in combination with antibody-drug conjugates (ADCs). Recently, Keytruda has demonstrated efficacy as a combination therapy for first-line treatment of non-small cell lung cancer, leading to a steady increase in prescriptions. Positive clinical results are also emerging for various solid tumors, including breast cancer, stomach cancer, lung cancer, and melanoma. In the domestic market, Keytruda continues to hold the lead in overall pharmaceutical sales.
