Drawn to the potential for improved selectivity and safety profiles of PARP-1-specific inhibitors over their first-generation counterparts, Merck KGaA signed an exclusive, worldwide license deal with Jiangsu Hengrui Pharmaceuticals Co. Ltd. worth up to €1.4 billion (US$1.5 billion) to gain access to the latter’s next-generation poly (ADP-ribose) polymerase (PARP)-1 inhibitor, HRS-1167. Read More
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC. Read More
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022. Read More
Lianbio Co. Ltd. announced mixed phase III top-line results on Oct. 30 for its in-licensed Demodex blepharitis treatment called TP-03, with the U.S. FDA-approved eyedrop hitting just one co-primary endpoint in the Libra trial on Chinese patients. Read More
Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group and will enable the company to advance its pipeline of musculoskeletal therapies. Read More
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments. Read More
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery. Read More
Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response, confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation. Read More
Fledgling biotechnology company Automera has launched in Singapore with $16 million in series A funding to develop its autophagy-targeting chimera small molecules (AUTACs) platform technology. Automera co-founder and chief technology officer Loong Wang told BioWorld that he and his business partner, Taiyang Zhang, decided to move into the biotechnology space in 2021. Read More
Peel Therapeutics believes evolutionary biology holds the key to developing new therapeutics for cancer and inflammation, a relatively unique approach in the world of biotech, but one that is bearing fruit: Its lead molecule is derived from camptothecin, a compound originating from the Chinese Happy Tree that is thought to have evolved as a plant defense mechanism, and it has progressed to a phase I dose escalation study in patients with advanced solid tumors. Read More
“Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo Alto, Calif.- and Singapore-based generative artificial intelligence (AI) biotech Gero is trying to figure out and, at the same time help the industry, “see what is actionable, reversible and what may not be” to help people avoid “hitting their heads against the wall” when tackling aging and aging-related diseases. Read More
Singapore’s Health Science Authority is rolling out new drug substance evidence requirements following consultations with stakeholders, and drugmakers will have one year to comply with the new regulations. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Biogen, Biosyngen Bridge, Calliditas, F2G, Genexine, Henlius, Highfield, Iksuda, Innocare, OLife Molecular, tsuka, Recce, Samsung Bioepis, SN Bioscience, Sumitomo. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Alphanavi, Anheart, Boehringer Ingelheim, Bristol Myers Squibb, Burning Rock, Immutep, Lianbio, Nippon Kayaku, Shanghai, Sumitomo Pharma. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Biosyngen, Calliditas, Genexine, Life Molecular, Sumitomo. Read More
