Akeso Inc. has been given the green light by China’s NMPA for its PD-1/CTLA-4 antibody Kaitanni (cadonilimab), which was approved for the treatment of patients with relapsed or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy. Read More
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine. Read More
Sunshine Guojian Pharmaceutical Co. Ltd. has granted Xiling Lab Pharmaceutical Co. Ltd. global rights to develop and commercialize the trastuzumab biosimilar Cipterbin (inetetamab) for antibody-drug conjugates (ADC) in a ¥1.03 billion (US$153 million) deal. Read More
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer. Read More
Shanghai Henlius Biotech Inc. has inked a deal to acquire greater China rights for two cancer-focused bifunctional sialidase programs from Palleon Pharmaceuticals Inc. In return, Palleon will receive an unspecified up-front payment and is eligible for up to $196.5 million in milestone payments. Read More
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare. Read More
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Arrowhead, Ascletis, Astellas, Biontech, Canariabio, Clover, H. Lundbeck, Otsuka, Pfizer, Takeda, Todos Medical. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Astellas, Biolinerx, Eli Lilly, Emergex Vaccines, Engeneic, Fate, Generian, Genfleet, Immunome, Mitobridge, Novavax, Ono, Transcenta. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Akeso, Ascentage, Astrazeneca, Daiichi Sankyo, Eli Lilly, Inflarx, Innovent Biologics, Jiangsu Recbio Technology, Kyowa Kirin, Pfizer, Prestige, Sinovac, Skye, Unibio Science, Valneva. Read More
