BlackJack3D
Deals and Financings
Shenzhen EurekaBio closed a $40 million Series B+ funding to support the commercialization of its EuLV™ Lentiviral Vector Production System, a technology that the company believes could transform large-scale production of lentiviral vectors. The system is based on stable cell lines and a serum-free suspension system. Eureka believes its novel technology will have a major impact in how cell and gene therapies are developed. The B+ round was led by Yeuxiu Industrial Fund, with participation from China funds and follow-on investments from US funds.
Chengdu Maxvax Biotechnology raised $40 million in a Series C financing round to advance its portfolio of seven vaccines, two of which are in clinical trials. The company develops innovative vaccines and immunotherapies to prevent and treat infectious diseases and cancer. Maxvax, which has five subsidiaries with over 300 employees, was founded in 2016. The company applies its three platforms — adjuvant, recombinant protein and mRNA technology – to develop novel products. The company has been recognized as a national high-tech enterprise. The C round was funded exclusively by the Shenzhen Capital Group.
Hangzhou Zylox-Tonbridge, a peripheral and neurovascular interventional device company, entered a $15 million deal to distribute and manufacture the entire device line of California’s Avinger (AVGR) in China (see story). Avinger offers intra-vascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease. Zylox-Tonbridge, which will have Greater China rights to the products, will buy $7.5 million of Avinger stock upfront and the rest after technology transfer. Avinger will also have distribution rights in the US and Germany for Zylox-Tonbridge’s peripheral vascular products.
Shanghai Haihe Biopharma out-licensed Japan and Southeast Asia rights for its lead drug, gumarontinib, an approved therapy for non-small cell lung cancer, to Taiho Pharma of Tokyo. In March 2023, gumarontinib was approved in China to treat non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations. Haihe has already applied for Japanese approval of the drug. Taiho will have rights to develop, manufacture and commercialize gumarontinib in its areas. Haihe will receive an upfront payment, and it will be eligible for milestones and royalties based on sales revenues.
Trials and Approvals
Suzhou Innovent (OTCPK:IVBIY) and AnHeart Therapeutics of Hangzhou have filed a second NDA of their partnered next-gen ROS1 TKI in China (see story). The new NDA, which has been accepted for review by China’s CDE, is for use of taletrectinib as a first-line therapy for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have not previously been treated with a ROS1 TKI. The first NDA filing was for NSCLC patients who have been previously treated with ROS1 TKIs. In 2021, Innovent entered a $189 million agreement with AnHeart to commercialize taletrectinib in Greater China.
Beijing’s Akeso (OTCPK:AKESF, HK: 9926) enrolled the first patient in a Phase III clinical trial of cadonilimab (a PD-1/CTLA-4 bispecific antibody) as a first-line treatment for patients with PD-L1 negative non-small cell lung cancer (see story). Cadonilimab will be combined with chemotherapy and compared to tislelizumab (a PD-1 antibody) combined with chemotherapy. Cadonilimab, which is being tested in more than 60 ongoing clinical studies, is already approved as a second/third line therapy for advanced cervical cancer, and it has completed a successful Phase III trial as a first-line gastric cancer therapy.
Nanjing TransThera was approved to begin a European Phase III trial of tinengotinib in patients with cholangiocarcinoma (CCA). CCA, a cancer in the tubes that carry the digestive fluid bile through the liver, is a rare but aggressive form of cancer. To be enrolled, patients must have FGFR-altered disease that is refractory/relapsed from chemotherapy or a FGFR Inhibitor. The European Phase III trial is part of a global study of the drug. Tinengotinib, a next-gen FGFR inhibitor, has shown potency against a variety of FGFR2 kinase domain mutations in Phase I and II trials for the CCA indication.
Jinan Qilu Pharma presented data from a Phase II trial showing that its QL1706 combination therapy of a PD-1 and CTLA-4 was effective against cervical cancer. The combination met its primary endpoint with an objective response rate of 33.8%. In August 2023, China’s NMPA accepted a new drug application for QL1706, the first MabPair product targeting PD-1 and CTLA-4 worldwide. Qilu will present the trial data at The European Society of Gynecological Oncology (ESGO) 2024 Conference later this week.
Disclosure: None.
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