China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development.
D&D Pharmatech Inc., a Korean-American firm commercializing innovation from Johns Hopkins University raised $51 million in a pre-IPO series C round, which sets the stage for an IPO in Seoul early next year.
Aum Biosciences Pte. Ltd., a company developing targeted cancer therapies, has closed a $27 million series A funding round. The Singapore-based company plans to use the proceeds to advance clinical development of its portfolio with immediate initiation of two phase II programs for MNK and tropomyosin receptor kinase inhibitors.
Abbisko Cayman Ltd. has raised $226 million through an IPO in Hong Kong, where it launched with an initial price of HK$12.46 (US$1.60) per share. The company, doing business as Abbisko Therapeutics, plans to use about a third of the proceeds for research and development of its lead candidate, ABSK-091, as a potential treatment for multiple solid tumors.
In its first big pharma deal since it was founded around a cell programming technology in 2009, Immusoft Corp. signed Takeda Pharmaceutical Co. Ltd. to a research collaboration and license option targeting rare inherited metabolic disorders. The agreement brings an undisclosed up-front fee and research funding to Immusoft, which is also eligible to earn more than $900 million if all options are exercised and all milestones hit.
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI).
Sumitomo Dainippon Pharma Co. Ltd., its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Co. Ltd. have inked a global collaboration agreement to jointly advance four new compounds for serious neuropsychiatric conditions. Sunovion granted Otsuka rights to collaboratively develop and commercialize the four compounds worldwide. In return, Sunovion will receive an up-front payment of $270 million and up to $620 million in development milestone payments for the agents, with the potential for more depending on additional indications. It could also receive sales milestones from Otsuka.
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name.
Celltrion Inc. is riding high after receiving full approval for Regkirona (regdanvimab), as a treatment for COVID-19 in South Korea, seven months after the Ministry of Food and Drug Safety (MFDS) granted it conditional marketing approval in February 2021.