South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
Minghui Pharmaceutical Ltd. is out-licensing its antibody-drug conjugate (ADC) MHB-088C to Qilu Pharmaceutical Co. Ltd. for China rights for up to ¥1.345 billion (US$186.44 million). Under terms of the deal, Qilu gains rights to develop and manufacture the ADC in greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.
The KRAS G12D mutation is the most common oncogenic KRAS variant, identified in approximately 34% of pancreatic ductal adenocarcinoma cases, 12% of colorectal cancers and 4% of lung adenocarcinomas.
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine.
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
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