BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs.
HONG KONG – China has approved the fourth homegrown CD47 antibody to start clinical trials, intensifying the local CD47 race. Chinese biologics developer I-Mab Biopharma (Shanghai) Co. Ltd. said it received the go-ahead for the clinical study of TJC-4, its differentiated fully human CD47 monoclonal antibody for treating advanced malignant tumors.
Macrogenics Inc. is taking a further step into Asia as it joins with I-Mab Biopharma (Shanghai) Co. Ltd. in a collaboration and license agreement to develop and commercialize enoblituzumab, an immune-optimized, anti-B7-H3 monoclonal antibody.
HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China.
HONG KONG - Incyte Corp. entered a collaboration and licensing deal to flip its greater China rights to an investigational anti-PD-1 monoclonal antibody to Zai Lab Ltd., of Shanghai. The candidate, INCMGA-0012, is currently being evaluated as a monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.
HONG KONG – Supported by the municipal government of Chongqing in China, a joint venture between South Korean drugmaker Binex Co. Ltd. and Chinese pharmaceutical company Chongqing Zein Pharmaceutical Co. Ltd. will be set up in the third quarter of this year.
In an era when data are more valuable than gold, China has rolled out new regulations to strengthen control of its human genetics data. Any foreign biotech companies or institutes intending to use Chinese data must engage a Chinese partner in the research project, amongst other new requirements.
SUZHOU, China – Global intellectual property lawyers and consultants are quick to advise U.S. and European biotechs that they need a “China strategy” – guidance that usually generates a response akin to Scarlett O’Hara’s famous “I’ll think about it tomorrow” speech. And who can blame biotechs for procrastinating? They’re beset with the here and now: raising money, managing contract research and manufacturing organizations, submitting grant applications, designing studies, filing patents, meeting with potential partners and seeking consensus with regulators. I had the same skepticism about a hurry-up approach to China. But after networking among some of the 800-plus attendees at...
"If you plan to be around five or 10 years from now, you have to have a Chinese strategy." That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex Pharmaceuticals Inc., and now executive chairman of Alkeus Pharmaceuticals Inc., had just returned from China where Shanghai Syntheall Pharmaceuticals Co. Ltd., a manufacturing subsidiary of Wuxi Apptec Co. Ltd., is the manufacturing site for starting materials for Vertex's hepatitis C drug Incivek (telaprevir). A combined massive government investment, a growing appetite for capitalism, and a shift from pharmaceutical industry service...
“Hey kids, let’s put on a show!” That was a famous line from the 1937 Broadway musical, Babes in Arms, shouted to exhort the old gang to take action to save the orphanage. As the theater market just put on its Tony Awards to assess the state of its industry, June is also the most active event season for biopharma, as the industry puts on its own long-running show, with the ASCO and BIO events taking center stage this month. Only this time, it’s not the orphanage that’s in need, but the orphan drugs – as well as the biosimilars,...