Deals and Financings 

Xynomic Pharma, a US-China oncology company, has acquired a worldwide license to an mTORC1/2 inhibitor developed by Boehringer Ingelheim in exchange for an $800 million package of upfront, milestone and royalty payments (see story). BI has completed a successful Phase I trial of BI 860585. In 2019, Xynomic plans to start two clinical trials of the molecule: a potentially pivotal Phase II trial combining BI 860585 with a standard-of-care treatment against breast cancer, and a Phase Ib trial in combination with Xynomic's RAF inhibitor as a colorectal cancer treatment.

Suzhou Innovent (HK: 01801) formed a $391.5 million collaboration for China rights to three clinical-stage drug candidates developed by Incyte (NSDQ: INCY) of Palo Alto, CA (see story). Innovent will make a $40 upfront payment, then follow with a $20 million milestone payment when it files its first China IND. It will also be responsible for $331.5 million in development, regulatory and commercial milestones. For Innovent, the agreement is the first time the company has ventured outside of its primary focus on antibody candidates. It expects to file the first IND in 2019. 

China's Gan & Lee Pharma out-licensed ex-China rights to three insulin analogs to Sandoz, the generics division of Novartis (NYSE: NVS) (see story). The three Gan & Lee products are biosimilars to glargine, lispro and aspart, which have combined global market sales of $12 billion. Sandoz will have commercialization rights to the biosimilars in most ex-China markets, including the EU, the US, Switzerland, Japan, South Korea, Canada, Australia and New Zealand markets. The financial terms of the agreement were not disclosed. Gan & Lee is based in Beijing.  

Shanghai Cell Therapy Group raised $136 million in a C round (see story). Established in 2000, the company is a precision medicine company, offering cancer diagnosis and treatment, plus services that include cell production, cell cryopreservation, genetic testing and cell-related products. It is also constructing a clinical medical database, and it has established the Shanghai Wu Mengchao-Nobel Laureate Joint Medical Technology and Innovation Center. The funding was led by China Pacific Insurance, Haier Capital and China Industrial Asset Management.  

VoxelCloud closed a $50 million Series B funding to support its AI-based automated medical image analysis and clinical decision support systems (see story). Founded in 2015, VoxelCloud has offices in Los Angeles, Suzhou and Shanghai. The company believes its next-generation artificial intelligence and cloud computing -- along with first-class data -- will help realize its global goals. It currently offers automated reading of scans for lung cancer, retinal diseases, and coronary heart disease.  

GenomiCare Biotechnology, a Shanghai precision cancer company, completed a $30 million Series A+ financing round that was led by Trustbridge Partners and included General Oriental and GP Healthcare Capital (see story). GenomiCare says its precision cancer medicine platform was co-built by China and American biomedical scientists to be an international company. It provides precision medicine screening, implementation and monitoring to China cancer patients and doctors.  

Lee's Pharm, a China in-licensing company, announced a $22.5 million agreement for China and Southeast Asia rights to a preclinical cardioprotective molecule developed by Auransa of Palo Alto, CA (see story). Auransa uses its SMarTR™ Engine AI-driven platform to discover non-obvious drug candidates. AU018 is intended to be administered along with doxorubicin to mitigate the cardiotoxicity side effect of the chemotherapy. In early testing, AU018 did not interfere with doxorubicin's activity.  

I-Mab Biopharma of Shanghai partnered greater China rights for its long-acting GLP-1 Fc type 2 diabetes product to CSPC Pharma (HK: 01093) in a $22 million agreement (see story). TG103's long-acting formulation allows once-weekly or bi-weekly subcutaneous administration. CSPC will make a $2 million upfront payment and up to $20 million in milestones. I-Mab will also receive royalties on sales, while CSPC will contribute to development expenses. I-Mab was formed in early 2017 with backing from C-Bridge Capital and Tasly Pharma.  

Autobio Diagnostics (SHA: 603658), a Zhengzhou IVD company, will form a $19 million JV with Finland's Mobidiag to bring Mobidiag's Novodiag® platform to China (see story). The platform offers assays for human infectious disease, and the JV will focus initially on assays to detect respiratory and gastroenteric infections and meningitis. Autobio will contribute $14 million for a 65% stake in the JV, while Mobidiag will add $5 million for the rest. In addition, Autobio will make a $11.4 million investment in Mobidiag, though Autobio stressed the transaction was separate from the JV deal.  

Aptorum Group (NSDQ: APM), a preclinical Hong Kong pharma, completed a $12 million IPO on the NASDAQ exchange (see story). The company is developing therapeutic drugs, many of which are based on natural substances, along with surgical robotic devices. It expects to file for approval of at least one of its three lead products in the US, China or the EU by 2021. In the IPO, the company placed 761,419 Class A Shares at a price of $15.80 per share, but in their first trading session, the shares lost 11%, dropping to $14.00 

Anji Pharma, a Boston-Shanghai startup, in-licensed China rights to pradigastat, a potential treatment for hyperlipoproteinemia currently in a Phase III trial, from Novartis (NYSE: NVS) (see story). Hyperlipoproteinemia results from an inability to break down lipids or fats, specifically cholesterol and triglycerides. Anji paid Novartis $2 million upfront and will make additional milestone and royalty payments. Initially, Anji will conduct China trials for the candidate; it plans to eventually pursue additional indications. Anji is a genomically based drug discovery company with Shanghai clinical operations.  

Ascentage Pharma of Suzhou formed a strategic collaboration with Shanghai's Genor Biopharma that will test a combination of Ascentage's MDM2-p53 inhibitor and Genor's anti-PD-1 mAb (see story). MDM2 inhibits the function of p53 through direct protein-protein interaction, Ascentage's specialty. The two companies will conduct preclinical and clinical studies in both solid tumors and hematologic malignancies. Earlier this year, Ascentage filed for an IPO on the Hong Kong exchange.  

Trials and Approvals 

Junshi Biosciences of Shanghai announced Tuoyi (toripalimab), its anti-PD-1 checkpoint inhibitor, was approved in China as a second-line treatment for melanoma, the first domestic PD-1 approved in China (see story). There are three other China-developed anti-PD-1 mAbs under review by the NMPA. Tuoyi joins two US already-China-approved PD-1 products in the market: Keytruda from Merck (NYSE: MRK) and Opdivo from Bristol-Myers Squibb (NYSE: BMY). Junshi is completing a $400 million IPO on the Hong Kong Exchange.  

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