Beijing Hanmi Pharm. Co. Ltd. broke ground on a ₩140 billion (US$98.65 million) large-scale project to build a near-500,000-square-foot China base near Beijing Capital International Airport in efforts to increase the company’s local production, R&D and office capabilities.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase I study for lymphomas.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Bioarctic, Biocon, Innovent, Mesoblast, Simcere, Travere Therapeutics, Verrica.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akeso, Astrazeneca, Cynata Therapeutics, Everest, Hua Medicine, Inventisbio, MEsoblast Vasomune Therapeutics.
Although it does not generally infect humans, a single mutation of the H5N1 virus in the highly pathogenic avian and bovine clade 2.3.4.4b could overcome this barrier and possibly trigger a pandemic.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Atom Therapeutics, China Medical Systems, Congruence, Dewpoint, GSK, Keros, Martin, Mitsubishi Tanabe, Ono Pharmaceutical, Nkgen, Nkmax, Northstar Medical, Peptidream, Takeda, Zhifei.
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