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- 2026-03-11 19:27:33
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- Expansion of NIP needed for 20-valent pneumococcal vaccine
- by Whang, byung-woo Jan 08, 2025 05:53am
- "Invasive pneumococcal disease remains the most common invasive infection and poses a significant burden. Pneumococcal diseases, such as pneumonia or ear infection, pose significant burden. The new vaccine must cover conventional serotypes as well as newly introduced serotypes to manage the invasive pneumococcal infection and expect an additional reduction." The introduction of the pneumococcal vaccine with the most serotypes in South Korea has brought attention to its preventive effects against pneumococcus and unmet needs for vaccines. Given the availability of vaccines in the National Immunization Program (NIP), there is a heightened interest in the preventive effects of added serotypes. Dr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of MedicineDr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of Medicine, emphasizes the importance of seeking ways to improve preventive effects in terms of society, given the additional effects of newly introduced drugs. According to Dr. Yun, unlike viral infection, bacterial infection cannot be recovered by relying on immunity, requiring antibiotic treatment. Mortality in children has decreased compared to the past, but bacterial infection still needs considerable attention. "Bacterial infection is one of the most burdening diseases in children. The prevalence decreased over time due to vaccine development and environmental improvement. Yet, the disease prevalence is higher than other diseases," Yun explained. "Not only children with immature immunity but seniors are prone to respiratory infections. Consequently, children and seniors are the primary patients for respiratory prevention and treatment." Dr. Yun comments that given these factors, it is crucial to prevent infection through vaccination and to stop it from transitioning to severe stages. Invasive pneumococcal disease remains the most common invasive infection and poses a high disease burden, so the importance of vaccination has been stressed. "Bacterial identification is challenging for infections related to pneumococcus, leading to frequent use of antibiotics. Consequently, patients may experience aftermaths of the treatment," Dr. Yun stated. "Vaccines can prevent these issues and may alleviate antibiotic tolerance by reducing the volume of antibiotic use." The government has included 13-valent and 15-valent pneumococcal vaccines in the NIP for children. From a different view, it remains to be seen what impact of Prevenar 20, a recently approved vaccine containing 20 serotypes, will have. Dr. Yun focuses on newly identified serotypes not included in the 13-valent vaccine as primary causes of infection. "13-valent vaccine alone cannot prevent all serotypes, so vaccines that contain new serotypes may be necessary," Dr. Yun said. "New vaccine must cover conventional serotypes as well as newly introduced serotypes to manage invasive pneumococcal infection and expect additional reduction." "Because Prevenar 20 also met non-inferiority to 13-valent vaccines, and it met immunogenicity requirements set by WHO at the fourth immunization, using the vaccine will likely be similar to the conventional vaccine," Dr. Yun added. "Additional serotypes can also offer disease prevention, so clinical benefits are expected." "The 20-valent pneumococcal vaccine has established sufficient validity for the NIP…establishing mass immunity must be considered" The remaining issue is whether the vaccine will be included in the NIP. While it offers broader prophylaxis than conventional vaccines, its introduction faces cost concerns due to the existing conventional vaccines already being part of the NIP. Dr. Yun analyzes that considering foreign cases, disease burden, and as drug price increases, Prevenar 20 has established sufficient validity for the NIP. "The 20-valent vaccine includes seven additional serotypes compared to conventional vaccines, potentially providing about 40-50% additional prevention against invasive pneumococcal infections. This suggests that the vaccine is more effective than existing ones," Dr. Yun said. "About 70-80% of non-vaccine serotypes causing infections in South Korea are not included in existing vaccines," Dr. Yun stated. "About half of these are serotypes included in the 20-valent vaccine. Consequently, it may be inadequate to keep using existing vaccines." Dr. Yun particularly emphasizes that to maximize the effects of the pneumococcal vaccine, increasing the vaccination rate for mass immunity must be considered. The 13-valent conjugate vaccine previously achieved high vaccination rates and demonstrative high effectiveness. However, a drop in vaccination rates due to new vaccines not being included in the NIP may lead to an increase in invasive infections and pneumonia. "Rather than expecting protection from individual vaccination, we must consider approaches generating society-wise preventive effects. Considering these views, there must be active measures to increase the vaccination rate with new vaccines such as Prevenar 20," Dr. Yun said. Finally, Dr. Yun remarked, "Despite the significant burden of pneumococcal diseases, such as pneumonia or ear infection, a surveillance system has not been established in South Korea." Adding, "The Korea Disease Control and Prevention Agency (KDCA) must address these aspects and implement systematic improvements so that invasive pneumococcal diseases are not overlooked."
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- New drug 'Truqap' for HER2- breast cancer Rx available
- by Son, Hyung Min Jan 08, 2025 05:53am
- Product photo of AstraZeneca Korea'Truqap,' an oral anticancer drug that targets AKT gene mutation, is now available for prescription at general hospitals. According to industry sources, AstraZeneca Korea's Truqap (capivasertib), a treatment for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital, and medical centers, including Gachon University Gil Medical center, Gangnam Severance Hospital, Korea University ANAM Hospital, Seoul National University Bundang Hospital, and Cha University Bungdang Medical Center. Domestically approved in March 2024, Truqap was launched as a non-reimbursable drug in September of the same year. This drug can be prescribed for combination therapy with fulvestrant following progression on or after an endocrine therapy or recurrence within 12 months after adjuvant therapy. The introduction of Truqap is significant because it offers more second-line treatment options following first-line treatment of HR-positive/HER2-negative breast cancer where there have been unmet needs. HR-positive/HER2-negative breast cancer accounts for 70% of the total breast cancer patients. This drug was demonstrated to be efficacious based on the CAPItello-291 Phase 3 study. The results showed that Truqap improved the median progression-free survival (mPFS) by approximately 2.5-fold compared to fulvestrant alone in patients who failed the first-line treatment following endocrine therapy (ET)±CDK4/6 inhibitor therapy. In detail, the Truqap+fulvestrant combination group had a mPFS of 7.3 months, which is more than double the 3.1 months with fulvestant alone. "Patients with PIK3CA/AKT1/PTEN mutations, accounting for about 50% of patients with HR-positive/HER2-negative breast cancer, may have faster disease progression; therefore, there has been a consistent need for second-line treatment for metastatic breast cancer targeting these mutations," Dr. Kywong Hwa Park, Professor of the Division of Oncology at Korea University ANAM Hospital, explained. "In metastatic breast cancer, patients who achieve complete recovery with a first-line treatment is rare, and most patients fail treatments, leading to the second-line treatments or more. The mutation targeted by Truqap commonly metastasizes to various organs, so we anticipate a positive outlook with this medication," Dr. Park said.
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- Twice yearly HIV drug 'lenacapavir' receives ODD
- by Eo, Yun-Ho Jan 07, 2025 06:05am
- Product photo of Sunlenca Twice yearly injectable 'lenacapavir' for HIV prevention has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) recently announced this through the new year's first orphan drug designation notification. The drug is indicated 'In combination with other antiretroviral therapy, for treatment of patients with multidrug-resistant HIV-1 infection for whom cannot be treated with antiretrovirals.' This drug, marketed under the product name as 'Sunlenca,' is a first-in-class long-acting HIV-1 capsid inhibitor that is subcutaneously administered every six months. It was approved in the United States and Europe in 2022 and has been prescribed. The current HIV treatment regimen requires daily oral administration of antiretrovirals. As long-acting agents become available, the treatment frequency has been extended to two or six months. Sunlenca offers not only HIV treatment but also 'prevention.' In September 2024, this drug's developer, Gilead Sciences, announced the second interim result of lenacapavir's Phase 3 PURPOSE2 trial. The result has shown that lenacapavir reduced HIV infection by 96% compared to baseline HIV prevalence (HIV). Only two cases occurred among 2180 study participants, suggesting that 99.9% of the participants in the lenacapavir-treated group had not been infected with HIV. The PURPOSE 2 study is the second key Phase 3 trial evaluating the efficacy of twice-yearly lenacapavir as a pre-exposure prophylaxis (PrEP) used to prevent HIV. In June 2024, Gilead Sciences concluded the double-blind trial conducted in Sub-Saharan Africa early after meeting the key endpoints. This PURPOSE1 clinical trial evaluated lenacapavir as a PrEP among cisgender women. Science, the academic journal and outlet for scientific news, has named lenacapavir as 'Breakthrough of the Year' based on these study results.
- Company
- AstraZeneca Korea recertified Innovative Pharma Company
- by Whang, byung-woo Jan 07, 2025 06:05am
- AstraZeneca Korea announced today that it has successfully extended its certification as a 2024 Innovative Pharmaceutical Company by the Ministry of Health and Welfare. This marks the third consecutive recertification since the company was first certified in 2018, and recognizes the company's steady R&D investments and achievements made through global collaborations. With the extension, AstraZeneca Korea will be maintaining its status as an Innovative Pharmaceutical Company for another three years, until 2027. The Innovative Pharmaceutical Company certification system, which is organized by the Ministry of Health and Welfare, is based on the ‘Special Act on Fostering and Supporting the Pharmaceutical Industry,’ which reviews companies with high R&D investment ratios and excellent performance in developing new drugs. Certified companies can receive various support, including points for R&D support, preferential drug pricing, and tax benefits. Through its Open Innovation strategy, AstraZeneca Korea has been strengthening its collaboration with local researchers and companies to contribute to the development of the Korean pharmaceutical industry. In particular, the approval of durvalumab for the first-line treatment of biliary tract cancer in 2022 resulted from clinical trials led by local researchers and is considered a successful global collaboration model. Also, AstraZeneca Korea was recognized for its rapid response to the health crisis during the COVID-19 pandemic. The company invests around 20% of its annual revenue in clinical research, with more than 180 clinical studies underway in Korea. In addition, the company has continued to invest in R&D by conducting clinical trials on next-generation innovative drugs such as antibody-drug conjugates (ADCs), radioconjugates, and cell gene therapies in Korea. “The extension of the Innovative Pharmaceutical Company certification is an achievement of our long-standing collaboration with the Korean healthcare industry,” said Sehwan Chon, Country President of AstraZeneca Korea. ”We will continue to work closely with Korean research institutes and companies to create a patient-focused healthcare ecosystem and expand our innovative pipeline.” Chon added, “We look forward to further collaborating with the government, academia, and industry to raise the global profile of Korea's healthcare industry.”
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- 1st RSV preventive inj 'Beyfortus' can be prescribed
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- Product photo of Beyfortus The first injectable antibody drug approved in South Korea to prevent respiratory syncytial virus (RSV), 'Beyfortus,' is now available for prescription at general hospitals. According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DC) of medical centers, including Seoul National University Hospital, Cha University Gangnam Medical Center, Korea University Anam Hospital, Korea University Ansan Hospital, Cha University Bundang Medical Center, and Pusan National University Yangsan Hospital. Beyfortus was approved by the Ministry of Food and Drug Safety (MFDS) in May as an injectable antibody to prevent RSV. It can be administered to all newborns and infants during their first RSV season. Beyfortus can also be given to infants under 24 months who are at high risk for severe RSV disease during their second RSV season. The Phase 3 MELODY study, which was the basis of Beyfortus approval, showed that the lower respiratory infection by RSV was reduced by 74.5% in the Beyfortus-treated group. This study evaluated the effectiveness of Beyfortus in 3012 infants born after 35 weeks during their first RSV season. The effectiveness in preventing RSV infections requiring medical attention was assessed until 150 days after the Beyfortus administration. Based on the Beyfortus real-world evidence demonstrated in the interim results from the national immunization program in Galicia, Spain, infants six months or younger who were administered Beyfortus had an 82% reduction in hospitalization due to RSC compared to non-administered infants. "Individuals of all ages can be contracted with RSV, but 90% of infants under 2 years old become infected. When infected, a mild cold symptom can advance to lung infections, possibly leading to hospitalization," Ki Wook Yun, Professor of Seoul National University College of Medicine, explained. "When infants without completely developed bronchial tubes contract RSV, symptoms can be worse. It could result in socioeconomic loss in addition to affecting family members." Yun added, "Since taking care of one's hygiene was the only RSV prevention available, there were unmet needs for RSV prevention. With the availability of injectable antibody drug, active RSV prevention is expected to be possible."
- Company
- Balversa may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- The new bladder cancer drug Balversa may now be prescribed in Korea’s Big 5 tertiary hospitals in Korea. According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. In addition, the drug’s prescription codes have been generated at major medical institutions across the country, including Kangnam Sacred Heart Hospital, GangNeung Asan Hospital, Hallym University Kangnam Sacred Heart Hospital, National Cancer Center, Keimyung National University Hospital, Ulsan National University Hospital, Korea Cancer Center Hospital, and Chonnam National University Hwasun Hospital. Balversa was approved by the Ministry of Food and Drug Safety in January 2022, but it is still not reimbursed in Korea. But expectations have been rising since Janssen submitted a reimbursement application for Balversa at the end of last year. As such, it remains to be seen if Balversa will be reimbursed by the end of the year and become a viable treatment option in Korea. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents. The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Balversa’s indication. Janssen Korea has additionally submitted the results from the THOR study to Korea’s Ministry of Food and Drug Safety. Therefore, the company may start the reimbursement progress in earnest for Balversa in the second half of the year. Therefore, it remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance reimbursement in Korea. Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option. Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR). FGFR is a biomarker involved in cancer cell growth that is associated with various cancers. FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.
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- Lily's 'Jaypirca' launches in KOR
- by Whang, byung-woo Jan 03, 2025 06:28am
- Product photo of Jaypirca Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26. To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind. Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) in August 2024 for its efficacy and effects as a 'monotherapy for adult patients with relapsed or refractory MCL previously received at least two treatments.' Before the approval of Jaypirca, there was no drug approved in South Korea for patients with relapsed or refractory MCL whose symptoms advanced after previously receiving a BTK inhibitor. Jaypirca is the first reversible BTK inhibitor to demonstrate clinical significance in patients with relapsed or refractory MCL who have undergone one or more BTK treatments. It selectively inhibits BTK with a 300-fold greater selectivity than any other kinases (98%) in a preclinical study. The basis for approval was the BRUIN Phase 1/2 clinical trials, which evaluated the effectiveness and safety of Jaypirca in patients with relapsed or refractory MCL who had previously received one or more BTK inhibitors. The primary analysis set (PAS), involving 90 patients who had previously been treated with one or more BTK inhibitors, had an overall response rate (ORR) of 56.7% and a duration of response (DoR) of 17.6 months. The most common adverse reactions after the Jaypirca treatment were fatigue (26.3%), decreased neutrophil count (22.8%), diarrhea (22.1%), and bruising (21%). The rate of discontinued treatment due to adverse reactions was 1.2%. The rate of reduced volume of treatment due to adverse reactions was 3.3%. Previously, Jaypirca was approved under the FDA's Accelerated Approval in January 2024 based on the response rate results. In South Korea, in June 2024, it was designated an orphan drug as the monotherapy for patients with relapsed or refractory MCL previously treated with BTK inhibitors. Last month, Jaypirca was the only drug considered for the reimbursement review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) to receive a reimbursement criteria decision. The remaining steps are the Drug Reimbursement Evaluation Committee (DREC) review, drug price negotiations with the National Health Insurance Service (NHIS), and a review from the Health Insurance Policy Review Committee. "The launch of Jaypirca is expected to expand the treatment opportunity for patients with MCL who couldn't continue treatment because there has been no alternative medication after the disease progressed after previous therapies," Mira Kyon, Head of Lily Korea Oncology Division, stated. "Lily will continue to put efforts into providing better patient treatment opportunities and suggesting new paradigms to blood cancer therapies."
- Company
- Will Fabhalta settle as a PNH treatment option in Korea?
- by Eo, Yun-Ho Jan 03, 2025 06:27am
- Whether another PNH treatment option will be born is gaining attention in Korea. According to industry sources, Novartis Korea has submitted a reimbursement application for its oral paroxysmal nocturnal hemoglobinuria (PNH) treatment Fabhalta (iptacopan). PNH is a rare disease with an estimated incidence of 1.5 per million people worldwide. The treatment of this disease has historically relied on C5 inhibitors. Soliris (eculizumab) was first approved in Korea in 2010 and Ultomiris (ravulizumab) was approved in 2022 for PNH. Both are C5 inhibitors that inhibit the terminal C5 in the alternative pathway of the complement system involved in the body's immunity and are injected intravenously. However, in April last year, Empaveli (pegcetacoplan), a subcutaneous injectable that binds to C3 and C3b and inhibits the complement chain reaction, was approved, followed in August by Fabhalta, an oral factor inhibitor. Mechanistic limitations of C5 inhibitors, ‘extravascular hemolysis’ PNH begins with a genetic deficiency in red blood cells, which leads to intravascular hemolysis (IVH) and extravascular hemolysis (EVH). Such type of hemolysis can soon lead to thrombosis and bone marrow failure, which can be life-threatening. This is why it is important to control hemolysis to treat PNH, and while the current standard of care for PNH, C5 inhibitors, reduce the risk of thromboembolism by controlling intravascular hemolysis, they have limitations in limiting extravascular hemolysis. This is why the reimbursement of factor B inhibitor Fabhalta is gaining interest. Factor B is an alternative pathway upstream of C5, as well as C3 and C3b, and its inhibition can comprehensively control not only IVH but also EVH. In fact, Fabhalta has shown efficacy in treatment-naïve patients. In the APPOINT-PNH study on treatment-naïve PNH patients, 19 of 33 patients achieved hemoglobin levels of 12 g/dL or higher without red blood cell transfusions. In addition, 92% of patients had shown a clinically significant increase in hemoglobin levels of 2 g/dL or more, and 63% of patients sustained a hemoglobin level of 12 g/dL or higher without transfusion. Over the 24-week study period, hemoglobin levels continued to increase, with normalized hemoglobin levels reached at week 20 and sustained through week 24. In addition, 98% of patients overcame transfusion dependency. “When C5 inhibitors first appeared, experts said they brought a paradigm shift in the treatment of PNH,” said Dr. Junho Jang, Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center. “However, C5 inhibitors still have limitations in controlling extravasation hemolysis (EVH).” He added, “Fabhalta represents another paradigm shift in the treatment of PNH. Its mechanism of action, which inhibits factor B, involves factor B at the top of the alternative complement pathway, which can control both intravascular and extravascular hemolysis. It has shown encouraging results in clinical trials.”
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- Yuhan’s anticancer drug Leclaza secures European approval
- by Cha, Jihyun Jan 02, 2025 06:10am
- Pic of Yuhan Corp Yuhan Corp’s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European launch milestone. According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp’s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. The CHMP had previously issued a positive opinion recommending approval of the combination on March 14th. The final approval of the combination comes just 1 month after the CHMP's recommendation. The approval is based on results from the Phase III MARIPOSA study. In the study, the combination of Rybrevant-Leclaza reduced the risk of disease progression or death by 30% compared to Tagrisso (osimertinib) monotherapy. In addition, progression-free survival (PFS) was 23.7 months, compared to 16.6 months with osimertinib, and duration of response (DOR) was 25.8 months, 9 months longer than Tagrisso's 16.8 months. Even in high-risk patients with TP53 mutations, brain metastases, or liver metastases, the combination of Rybrevant and Leclaza demonstrated a consistent PFS benefit over Tagrisso, with a trend toward superior overall survival (OS). This renders Leclaza the first homegrown anticancer drug to be marketed in Europe following approval in the U.S. The Rybrevant-Leclaza combination was previously approved by the U.S. Food and Drug Administration (FDA) in August. In Korea, it was approved by the Ministry of Food and Drug Safety in January 2021 for the treatment of non-small cell lung cancer. As the Rybrevant-Leclaza combination passed the European threshold, the company will receive the European launch milestone of USD 30 million (approximately KRW 44.2 billion). This brings the total amount received from Janssen for the export of Leclaza technology to USD 240 million (approximately KRW 353.7 billion). In November 2018, the company received USD 50 million in upfront payment for the export of Leclaza’s technology. In April 2020, Yuhan Corp received a milestone payment of USD 35 million from Janssen. At that time, Johnson & Johnson paid Yuhan Corp an additional milestone payment after initiating clinical trials for the Rybrevant and Leclaza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting patients for the trial. Subsequent successful completion of the trial and FDA approval resulted in an additional USD 60 million in additional milestone payments. Sales royalties are also expected to be recognized once the Rybrevant-Leclaza combination is launched in Europe. The royalty rate on sales of Leclaza is expected to be in the range of 10% to 12%. Lung cancer is the leading cause of cancer-related death, which causes an estimated 1.8 million deaths worldwide each year. Patients with non-small cell lung cancer, which is targeted by the Rybrevant-Leclaza combination, account for 80-85% of lung cancer patients. In addition, Yuhan Corp may receive additional milestones upon regulatory approval in Japan, China, and other Asian countries. The total amount of additional technology fees that Yuhan may receive for future development and sales of Leclaza amounts to USD 740 million.
- Company
- K-Bio to showcase CDMO·new drugs at the JP Morgan
- by Son, Hyung Min Jan 02, 2025 06:10am
- The Korean pharmaceutical and biotech industry is set to participate in the new year's first global event, the JP Morgan Healthcare Conference. Attention has been drawn to what the Korean pharmaceutical and biotech industry will accomplish during the event, which will include discussions of blockbuster technology transfers and partnering agreements. According to industry sources on January 2, Samsung Biologics, Lotte Biologics, Celltrion, Bridge Biotherapeutics, Onconic Therapeutics, and others will attend the JP Morgan Healthcare Conference. The Healthcare Conference, hosted by the US investment bank JP Morgan, is the largest pharmaceutical and biotech industry investment event, where venture capitals (VC) and hedge funds attend. The event will be held in San Francisco, US, for four days from January 8. Korean CDMO companies gear up to land contracts During the event, Samsung Biologics, Lotte Biologics, Celltrion, and other participants will showcase their contract development and manufacturing organization (CDMO) competitiveness. Samsung Biologics will showcase its biopharmaceutical CDMO competitiveness based on its new manufacturing plant, Plant 5, which will be completed in April. The company is constructing a plant at the Bio Campus in Songdo, Incheon, for antibody-drug conjugates (ADC) production, which is aimed to be completed within this year. Samsung Biologics currently has a total production capacity of 600,000 liters. The company has invested KRW 1.98 trillion in constructing Plant 5 in Songdo. Samsung Biologics will hold a total capacity of 784,000 liters across Plant 1-5. Celltrion will showcase its new drug development achievements, including a new ADC anti-cancer drug, and CDMO vision. The company unveiled the new ADC drug result of the Phase 1 clinical trial at the 'World ADC 2024' held in November last year. Celltrion Celltrion is conducting a clinical trial for 'CT-P70,' an ADC candidate product for non-small cell lung cancer (NSCLC), and 'CT-P71,' which targets many solid cancer indications, including bladder cancer. The safety of these new drug candidates has been confirmed in a phase 1 clinical trial and a pre-clinical trial, respectively. Additionally, Celltrion will initiate the business operations of its subsidiary, 'Celltrion BioSolutions,' which was launched in December 2024. Celltrion aims to build manufacturing facilities and a research center and generate sales from 2028. Lotte Biologics will attend the conference and plans to showcase its CDMO competitiveness. The company plans to build three bio plants in Songdo by 2023 with a total production capacity of 360,000 liters for antibody pharmaceutical production. The new Plant 1 will have a cell culture system and an API system for producing clinical agents. The company will design a 3,000-liter bioreactor capable of fulfilling the demand for both stainless steel bioreactors (cell culture system) and high-potent active pharmaceutical ingredients (HPAPI). Lotte Biologics aims to achieve global biopharmaceutical production competitiveness by investing up to KRW 4.6 trillion by 2030. To showcase achievements in new drug development…will this result in out-licensing opportunities? Onconic Therapeutics and Bridge Biotherapeutics have been officially invited to the JP Morgan Healthcare Conference, where they will showcase their competitiveness in new drug development. Onconic Therapeutics launched 'Ja Q Bo Tab,' a P-CAB for the treatment of gastroesophageal reflux disease (GERD), last year. Ja Q Bo Tab has been designated the 37th new drug in Korea. Additionally, Onconic Therapeutics successfully out-licensed Ja Q Bo to twenty-one foreign countries. Onconic Therapeutics plans to focus on holding strategic meetings with global pharmaceutical companies and investors during the upcoming JP Morgan Healthcare Conference. In addition to Ja Q Bo, the company plans to introduce the targeted anticancer agent, 'nesuparib,' to the global market. Onconic Therapeutics has been developing 'nesuparib,' a dual-targeting inhibitor of PARP·tankyrase, as the follow-up pipeline after Ja Q Bo. Bridge Biotherapeutics plans to present its key R&D projects, including the idiopathic pulmonary fibrosis (IPF) treatment candidate 'BBT-877,' and potential company growth strategy. BBT-877 is an innovative new drug candidate that selectively inhibits the new targeted protein autotaxin. Autotaxin is a protein involved in pathophysiological mechanisms, such as tumorigenesis, by binding with receptors in the cell. Bridge Biotherapeutics has completed enrolling 120 patients in the Phase 2 clinical trial for BBT-877. The comparative Phase 2 clinical trial will evaluate the effectiveness, safety, and drug tolerance by administering BBT-877 and placebo in patients with IPF. STCube will hold business meetings with multinational pharmaceutical companies to out-license 'nelmastobart.' The company is developing the candidate immune checkpoint inhibitor nelmastobart, which targets a new biomarker, BTN1A1. BTN1A1 is a protein that regulates the immune responses to cancer cells by suppressing the activity of T cells, which are immune cells. This biomarker is not expressed in healthy cells but is strongly expressed in cancer cells. BTN1A1 expression is mutually exclusive to that of PD-L1. By targeting BTN1A1, STCube is developing an immune checkpoint inhibitor that could be a new treatment option for intractable cancer. D&D Pharmatech will showcase the glucagon-like peptide 1 (GLP-1) receptor agonist for obesity. In November, D&D Pharmatech began the clinical trial for DD02, an oral GLP-1 drug for obesity, through its US partner, Metsera. D&D Pharmatech also plans to showcase the new drug candidate for treating MASH, DD01, which is undergoing a phase 2 clinical trial.
