- LOGIN
- MemberShip
- 2025-12-21 08:31:14
- Company
- 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.”
- Company
- 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.
- Company
- 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."
- Company
- 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.
- Policy
- BMS’s next-gen targeted drug repotrectinib approved in KOR
- by Lee, Hye-Kyung Jun 09, 2025 05:51am
- BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea. On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg. Specifically, repotrectinib is indicated as: ▲treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for pediatric patients 12 years and older and adult patients with locally advanced or metastatic solid tumors that are unsuitable for surgical resection due to high risk of severe complications and harbor an Neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Augtyro was first approved by the US FDA in November 2023 as a treatment for non-small cell lung cancer and was designated as an orphan drug in Korea last May. Since August last year, it has been prescribed to patients after receiving initial approval for its use in Korea for therapeutic purposes. The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial. The trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients. Progression-free survival (PFS) was nearly double that of previous targeted therapies. The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response). The median duration of response was 34.1 months. In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months. The trial also examined the drug’s efficacy in treating patients with resistance to existing targeted therapies. In the 56 patients with resistance to existing therapies, repotrectinib showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months. The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author. ROS1-positive NSCLC accounts for 2% of all lung cancers. The standard of care is to use targeted anti-cancer therapies that target the mutated gene. Commonly used drugs include ‘crizotinib’ and ‘entrectinib,’ and repotrectinib is gaining attention as a next-generation drug.
- Company
- 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.
- Company
- '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.
- Policy
- Lee 'will strengthen public nature of medical sector'
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- With the election of President Lee Jae-Myung, the legal community predicts that the government will strengthen its public policy in the healthcare and pharmaceutical biotechnology sectors. The areas of AI-based digital healthcare industry, rare and intractable disease coverage, and regional essential medical infrastructure will see new opportunities. There are also predictions that the medical industry and related platform technology industries will be revitalized as the institutionalization of non-face-to-face medical care (telemedicine) and home visits will expand the provision of medical services beyond geographical limitations. There are also analyses that public support for the pharmaceutical industry will expand, increasing opportunities for pharmaceutical and biotechnology companies. On the 4th, Shin & Kim LLC announced this in a special report on the results and impact of the 21st presidential election. President Lee Jae-Myung announced in his campaign pledge that he would strengthen the public nature of the medical and pharmaceutical industries. According to Shin & Kim LLC analysis, the new government will strengthen the public return support system through national R&D investment to foster the pharmaceutical and bio industries. In particular, it is expected that the government will establish a public consignment production and distribution system for essential medicines and promote the construction, public acquisition, and conversion of public hospitals. With the expansion of public support for the medical and pharmaceutical sectors, opportunities will rise for relevant companies, and the industry recommended parties to closely monitor the new government's efforts to achieve the two goals of strengthening public nature and fostering industry growth. To resolve supply instability and establish a stable supply system for essential medicines, the report suggested that policy measures should be developed with a focus on providing incentives to pharmaceutical companies and promoting limited International Nonproprietary Names (INN) based prescriptions. With the promised establishment of a regional essential medical care fund, policies to strengthen regional essential medical care infrastructure centered on regional medical schools and national university hospitals are expected to be promoted, which is seen as an increase in opportunity for regional medical institutions. Shin & Kim LLC stated that in terms of strengthening health insurance reimbursement coverage for medicines, particular focus will be placed on treatments for rare and intractable diseases. It is anticipated that the door to health insurance coverage for high-priced innovative drugs targeting rare and intractable diseases will be expanded and that the threshold for new drugs to enter health insurance coverage will be significantly lowered through the expansion of the Risk Sharing Agreement (RSA) scheme. In line with the pledges to institutionalize telemedicine and expand home visits and primary care physician systems, it is analyzed that policies for medical services that transcend geographical limitations will activate the medical industry and related platform industries. The Lee Jae-myung administration's medical reform plan sets out to organize a public debate committee as central governance, where medical professionals, experts, patients, and citizen representatives participate. Shin & Kim LLC diagnosed that it is necessary to closely monitor the direction set for the medical delivery system that starts from outpatient clinics to tertiary hospitals, regional medical infrastructure, and medical personnel supply to predict and respond to changes in the industrial landscape. Shin & Kim LLC explained, “The strengthening of the public nature of the medical and pharmaceutical industries will increase corporate social responsibility and alter the structure of market competition,” emphasizing the need for proactive measures in response. It added, ”The importance of profit management for medical institutions and related companies will increase due to the strengthening of price management for non-reimbursed medical services to stabilize Korea’s national health insurance finances.”
- Company
- 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.
- Policy
- Lee Jae-Myung elected as president of South Korea
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- Lee Jae-myung, the 21st President of South KoreaWith the election of Lee Jae-myung of the Democratic Party (Candidate No. 1) as the 21st President of South Korea, momentum is expected to build for key healthcare policies. These include the establishment of a National Medical Reform Public Opinion Committee to resolve conflicts between the medical community and the government, the promotion of limited International Nonproprietary Names-based prescriptions and generic substitutions to address drug supply instability, and the institutionalization of telemedicine with a standardized public e-prescription system. In particular, President Lee Jae-Myung has pledged to establish a system for telemedicine that complements in-hospital care, adheres to the principle of follow-up visits, and centers on neighborhood clinics, while halting indiscriminate pilot projects and establishing a management and supervision framework for intermediary platforms, is expected that the current unlimited telemedicine pilot project will be reasonably scaled back. From the pharmaceutical and biotech industry’s perspective, insiders are expecting a comprehensive overhaul of the drug pricing system, including granting higher drug prices to pharmaceutical companies that have invested heavily in R&D for innovative new drugs and strengthening mechanisms to remove generic drugs from the market if they fail to properly prove their efficacy. President Lee Jae-myung is expected to immediately begin implementing his campaign pledges on healthcare, pharmaceuticals and biotechnology, and health insurance without forming a transition committee. National Medical Reform Public Opinion Committee, Resolution of the medical-political conflict remains a challenge President Lee Jae-myung has decided to immediately begin work on establishing a National Medical Reform Public Opinion Committee that will involve the public, healthcare professionals, and experts from various fields. This is to resolve the ongoing issues triggered by the Yoon Suk-Yeol administration's policy to increase the number of medical school enrollment quotas by 2,000, which led to collective action by resident doctors and medical students in February last year and a medical staffing shortage. However, the Democratic Party has stated that it will not provide additional benefits to the resident doctors who participated in the collective action to resolve the conflict between the government and the medical community. Ultimately, it is likely that the committee will discuss solutions to the collective action by doctors and medical students. In addition, the policy to increase the number of medical school enrollment quotas is likely to be decided based on the results of the review by the Committee on Medical Manpower Planning, which was passed by the National Assembly with the agreement of both the ruling and opposition parties. This is because the Democratic Party of Korea's policy was to decide on the number of medical school enrollment quotas for the 2027 academic year and beyond through an objective and transparent deliberation process by the the Committee on Medical Manpower Planning, as the number of medical school enrollment quotas for the 2026 academic year has been set to return to 3,058. Furthermore, it is expected that Cho Kyoo-Hong, Minister of Health and Welfare, and Park Min-Soo, Second Vice Minister, who were at the forefront of the policy to increase the medical school enrollment quota, will be held accountable. As part of measures to strengthen regional and essential medical care, the government has promised to introduce a regional doctor system, establish public medical schools, and promote public medical academies. The government also plans to assign national university hospitals the role of base hospitals and expand public medical infrastructure by medical service area. Solutions to the drug shortage crisis, stronger government intervention, and INN-based prescriptions The solution to the supply instability of medicines pledged by the president involves strengthening government intervention in all stages of the process, from the supply of APIs for medicines that are frequently out of stock to the production of finished medicines and distribution to pharmacies. The government is expected to establish a list of frequently out-of-stock medicines and provide incentives for pharmaceutical companies to take an interest in producing APIs that are difficult to produce in Korea. The Democratic Party of Korea's policy is to increase profits for pharmaceutical companies that produce finished drugs using domestically produced raw materials show improved self-sufficiency rates and strengthen the public drug consignment manufacturing system for drugs in short supply. At the same time, the government will allow limited use of generic drug prescriptions for essential medicines with unstable supply. The government plans to resolve issues that caused significant inconvenience to the public during the COVID-19 pandemic, such as the shortage of acetaminophen for prescription drugs, by allowing limited INN-based prescriptions. President Lee also promised to promote substitute prescriptions as a solution to drug shortages. In response, there is a possibility that the current administration will go beyond allowing pharmacies to notify the Health Insurance Review and Assessment Service after dispensing substitute drugs, which is currently pending implementation, and introduce additional policies to increase the rate of substitute prescriptions. Legalization of telemedicine centered on local clinics and repeat patients gains momentum The possibility of legalizing telemedicine pilot projects within this year has also increased. President Lee promised to institutionalize telemedicine while ensuring safety and effectiveness. It is particularly noteworthy that the Democratic Party of Korea is preparing legislation to institutionalize telemedicine centered on “clinic-level” medical institutions and “repeat” patients. This is because the Democratic Party of Korea, which holds a majority of seats, has succeeded in changing the administration, greatly increasing the likelihood of the Democratic Party-led legislation of telemedicine. The Democratic Party of Korea is preparing a bill that would allow telemedicine to be used primarily by medical institutions at the clinic level, but also allow hospitals to provide telemedicine in special cases. In particular, the bill is expected to include provisions allowing telemedicine for initial consultations only for patients under 18 years of age and those over 65 years of age, while patients in other age groups would only be able to apply for telemedicine for follow-up consultations. In this case, the scope of eligible recipients for telemedicine would be significantly reduced compared to the current pilot program. Of course, since the amendment to the Medical Service Act to legalize telemedicine must undergo parliamentary review, the Democratic Party of Korea cannot make a unilateral decision on the matter. Unlike the 21st National Assembly, the 22nd National Assembly will see the ruling party change from the People Power Party to the Democratic Party of Korea, and it is expected that the Democratic Party's proposal will be reflected in the government's proposal to a considerable extent. The establishment of a public electronic prescription system will also be implemented along with the institutionalization of telemedicine. The Democratic Party of Korea plans to utilize public electronic prescriptions as a means to prevent the falsification and misuse of prescriptions and to prevent errors in the entry of prescription information during telemedicine. Pharmaceutical industry announces restructuring and advancement of drug pricing system President Lee announced a policy pledge to actively promote the pharmaceutical and bio industry as a new future growth engine for South Korea. As a measure to promote the pharmaceutical and bio industry, President Lee announced plans to revise the drug price system to focus on new drugs and strengthen the mechanism for removing generic drugs that have not been verified their effect from Korea’s health insurance reimbursement list. The most notable pledge is “drug price incentive linked to new drug R&D investment rates.” The vision is to create an environment where pharmaceutical and biotechnology companies can focus on developing new drugs by setting higher drug prices for medications produced by pharmaceutical companies that contribute significantly to innovative new drug R&D. This pledge was one of the policies proposed by multiple domestic pharmaceutical and biotech companies led by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government also promised to establish a more predictable drug pricing system to serve as a catalyst for new drug development and a cash cow for domestic pharmaceutical companies. The vision is to integrate drug price reduction mechanisms to establish a drug pricing system that encourages investment in new drug R&D. The president has also outlined a plan for the government to take the lead in establishing an R&D investment system and forming large-scale funds (megafunds) to promote industry development. In addition, the candidate's campaign promises include advancing the certification system for Korea Innovative Pharmaceutical Companies to expand R&D tax credits for certified innovative pharmaceutical companies, establishing a governance system that combines AI and big data technologies for the development of new drugs targeting global markets, and expanding risk-sharing agreements (RSA). To secure health insurance funds for these initiatives, the candidate proposed removing non-verified generic drugs from the market. In other words, the intention is to create some health insurance funds by more actively reevaluating the reimbursement of generics that have been approved for a long time but are not effective, thereby narrowing the scope of health insurance coverage. On the morning of the 4th, when his election was certain, the president-elect took the stage in front of the National Assembly and said, “The responsibility of a president in a united country is to bring the people together. I will never forget that my duty is not to be a great ruler, but to greatly unite the people.” Meanwhile, President Lee began his term as president immediately after the National Election Commission officially confirmed his election as president at 7 a.m. on the same day. President Lee held a brief inauguration ceremony at the National Assembly at 11 a.m. that day, after which he immediately appointed the Chief of Staff and began forming his Cabinet, including the Prime Minister.
