Image Source: Unsplash

Deals and Financings

• In a $480 million deal, Zenas, a Shanghai-Boston biopharma, acquired global rights to a bifunctional antibody from Xencor (XNCR) that targets CD19 (see story). The candidate uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which function in the immune system. The candidate, obexelimab, is in pre-clinical development. Instead of an upfront payment, Zenas will issue a warrant granting Xencor the right to acquire additional Zenas shares up to 15% of Zenas’ equity. Zenas will also pay $480 million in milestones plus royalties on sales.
• Suzhou CStone Pharma (2616.HK) out-licensed greater China rights for its CTLA-4 mAb to Jiangsu Hengrui Pharma (600276.SS) in a $200 million agreement (see story). Hengrui will have rights to develop, manufacture, and commercialize CS1002 in the territories. CStone has completed a successful China Phase I trial of CS1002 in combination with its PD-1 that enrolled patients with melanoma, hepatocellular carcinoma, and microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) tumors. The company will receive up to $200 million in upfront and milestone payments, plus double-digit royalties from Hengrui.
• Changzhou Tongshu Biotechnology raised $78 million in a C round to support its gene testing products for cancer diagnoses, which are based on multiple innovative platforms (see story). Founded in 2016, Tongshu Gene has developed IVD products that use ctDNA for early cancer screening tests. It will use the capital to continue developing its products and to build direct sales channels to more than 500 tertiary hospitals. The round was led by GL Capital Group, Broad Vision Funds, and Oceanpine Capital. It included new investors Jinyuan Capital, Haichuang Fund of Funds, and Yinhe Yuanhui Investment.
• Neurophth Therapeutics, a Wuhan-San Diego ophthalmic gene therapy company, closed a more-than $60 million Series C financing from China and international investors (see story). Neurophth's lead candidate is the first AAV2 gene therapy IND application approved in China. The company said it would use the funds to advance its lead therapy for Leber hereditary optic neuropathy (LHON), a genetic blindness condition, outside of China after starting China trials in June 2021. The C round was led by CMG-SDIC Capital and Sequoia Capital China.
• Allorion Therapeutics of Boston and Guangzhou completed a $40 million Series A financing to develop next-gen precision medicines for oncology and autoimmune disease (see story). Allorion claims its discovery platform combines technological breakthroughs in protein structure, big data, machine learning, and gene editing. The platform delivers highly selective small molecules, including covalent and allosteric inhibitors of well-validated targets. Allorion is completing IND-enabling studies and IND applications for two drug candidates in China and the US. The A round was led by Qiming Venture Partners. 
• Nanjing Simcere Pharma (2096.HK) has formed a collaboration to develop novel antiviral drugs for COVID-19 with the Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences (see story). Specifically, Simcere has exclusive global rights to develop and commercialize a small-molecule antiviral that targets the 3C-like protease, a key enzyme in the replication and of coronaviruses. In preclinical animal models, SIM0417 showed good antiviral activity and safety against SARS-CoV-2. The two entities will work together to promote clinical research and marketing of the candidate.

News 

• Beijing's BeiGene (BGNE) closed on a 42-acre US site in the Princeton, NJ area where it will build a manufacturing center and house clinical R&D operations (see story). The company said it would invest hundreds of millions of dollars to build a state-of-the art 400,000 square feet biologic manufacturing facility. In its first phase, the plant will include up to 16,000 liters of biologics capacity, along with clinical R&D and office space. The site has more than one million square feet of space for additional facilities as needed.
• The two co-founders of the WuXi AppTech/WuXi Biologics CROs, Drs. Ge Li and Ning Zhao, have made a $20 million charitable gift to Memorial Sloan Kettering Cancer Center (MSK) in New York City for cancer research (see story). The Ge Li & Ning Zhao Family Foundation gave the money to MSK to support lung cancer research and develop new therapies. The money will be used to create three Ning Zhao & Ge Li endowed chairs at MSK and a research fund to underwrite basic, translational, and clinical research.

Trials and Approvals 

• 3D Medicines reported that China's NMPA approved the launch of its anti-PD-L1 therapy, the first subcutaneously administered anti-PD-L1 approved anywhere in the world (see story). Envafolimab, a novel single-domain antibody against PD-L1, is approved as a second line therapy for MSI-H/dMMR cancer in patients with advanced solid tumors. Alphamab Oncology (9966.HK) originally discovered the drug, and 3D Medicines became its partner, with both companies responsible for clinical development. Tracon Pharma (TCON) shares US rights to envafolimab with the two China biopharmas while Simcere will commercialize envafolimab in China.
• Apollomics dosed the first patient in a China Phase III trial of uproleselan to treat relapsed or refractory acute myeloid leukemia (see story). APL-106 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, disrupting leukemic cell resistance within the bone marrow microenvironment. In 2020, Apollomics in-licensed Greater China rights to uproleselan from GlycoMimetics in a two-drug, $189 million deal. Apollomics is headquartered in Foster City, CA with China operations in Hangzhou and Shanghai.