Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause. Read More
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children. Read More
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd. Read More
Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon, which is based in Guangdong, China, obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Seoul, Korea-based Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments. Read More
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China. Read More
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed. London-based Invox announced its plans to acquire F-star in June 2022 for $161 million to build up the presence of its parent company, Sino Biopharm Ltd., outside of China. Read More
A California man agreed to settle insider trading charges related to Tokyo-based Astellas Pharma Inc.’s buyout offer of San Francisco-based Audentes Therapeutics Inc. in December 2019 for $3 billion. Mahmoud Abdelkader’s wife worked for Audentes and allegedly determined from “facts he learned from his wife, that there was a high likelihood of Audentes being acquired,” the SEC’s complaint said. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alterity, Astellas, Astrazeneca, Ausperbio, Bionomics, Biothera Solutions, Daiichi Sankyo, Dyadic, Genfleet, Harbour, Immunovant, Innocare, JW. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Akston, Alpha Fusion, Astellas, Biocytogen, Bridgene, Concert, F-star, Hummingbird Bioscience, Invivyd, Invox, Janssen, Johnson & Johnson, Kyorin, Myovant Sciences, Phanes, Pharma15, Radiopharm, Sino, Stelis, Sumitomo, Sumitovant, Sun Pharmaceutical Industries, Takeda, Tessa, Xyphos. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astellas, Bioarctic, Eisai, Mesoblast, Revive, Seagen, Takeda. Read More
