Deals and Financings

Shanghai's I-Mab (NSDQ: IMAB) out-licensed ex-China rights for lemzoparlimab, its anti-CD47 mAb, to AbbVie (NYSE: ABBV) in a blockbuster $2 billion agreement (see story). Separately, AbbVie also acquired right-of-first-refusal to two other CD47 molecules, which if exercised, would each trigger a $500 million payment. And I-Mab raised $418 million in a private placement from Hillhouse and other investors to support trials of its clinical candidates. I-Mab said it chose AbbVie because of its immunoncology and clinical development expertise. It added that testing a combination therapy of the CD47 and AbbVie's Bcl-2 inhibitor is a possibility.

Carlyle Group, a US private equity firm, invested $260 million in Shenzhen Salubris Pharma (SHZ: 002264) to buy a 5% stake (see story). Salubris makes finished drugs and medical devices for cardiovascular, oncology and anti-infective needs. In a statement, Carlyle said China's new methods of reimbursement will cause consolidation among domestic generic drug companies, giving the surviving companies greater market share. With Carlyle's help, Salubris will expand into the US, possibly through M&A.

Adlai Nortye Biopharma of Hangzhou raised nearly $100 million in a C financing to support development of its immunoncology portfolio (see story). Founded in 2016, the company has three candidates in clinical trials and at least ten more undergoing pre-clinical tests.  The fundraising was led by Hangzhou Tigermed and Yingke Capital. Because it targets global markets, Adlai Nortye has established a US R&D and clinical operations center in New Jersey, in addition to its China facilities.  

Waterstone Pharmaceuticals (Wuhan) completed a $63 million Series C financing led by SDIC Juli Investment (see story). Founded in 2009, Waterstone is known for making APIs, intermediates and generic drugs, but it has also branched into novel biologic drugs over the last few years. The company has four molecules ready to begin clinical trials for kidney and metabolic diseases, with more in earlier development. Panxi Capital, YuanBio Venture Capita and Yichang State-owned Investment Ronghe also participated in the round. 

CoWin Biosciences, a Beijing biological reagent company, closed a $36 million financing led by Addor Capital with Green Pine Capital Partners and Share Capital participating (see story). Established in 2007, CoWin Biosciences provides high quality biology reagents for life science research and molecular diagnostics. In July, the company's novel SARS-CoV-2  Fast Nucleic Acid Detection Kit was approved for use in the US. The kit detects the virus' nucleocapsid and ORF1ab genes in oropharyngeal swabs. 

InxMed (Nanjing), a clinical-stage biopharma focusing on developing "Best-in-Disease Combination" medicines, completed a $19 million Series A+ round (see story). InxMed's major project, IN10018, is an active ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor. According to InxMed,  IN100018 overcame drug resistance faced by KRAS G12C inhibitors in preclinical tests. The company is conducting clinical trials of IN10018 in the US, Australia and China for four indications. The financing was led by Ennovation Ventures and China Growth Capital with InnoMed Capital and Grand Yangtze Capital participating.  

Trials and Approvals 

Suzhou Innovent Bio (HK: 01801) was approved by China's NMPA to market Sulinno® (adalimumab), a Humira® biosimilar (see story). Sulinno, a recombinant human anti-TNF-α monoclonal antibody, is indicated to treat rheumatoid arthritis, ankylosing spondylitis and psoriasis. Sulinno is Innovent's third monoclonal antibody drug to hit the market, joining Tyvyt® , the company's PD-1 mAb indicated for Hodgkin's lymphoma, and Byvasda® , an Avastin biosimilar for NSCLC and colorectal cancer. Innovent noted that Sulinno is the company's first product approved for a non-oncology indication.

CStone Pharma (HK: 2616) of Suzhou has been approved to start a US Phase II trial of its PD-L1 mAb in patients with a relatively rare, difficult-to-treat form of lymphoma (see story). Cstone's sugemalimab (CS1001) will be tested as a monotherapy in relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL). The disease has a one-year survival rate of less than 20% in currently available treatments, but a 72% rate with sugemalimab. The US trial will extend a similar test already underway in China.

Innovent (HK: 01801) presented positive data from China Phase I and II tests of its PCSK9 mAb anti-cholesterol treatment (see story). In the Phase II trial, tafolecimab demonstrated LDL-C reductions were 54 % in healthy subjects and 72% in hypercholesterolemia patients. In addition, tafolecimab was dosed at intervals of six and up to eight weeks, which is longer than the competition.  

Innovent (HK: 01801) started a China Phase I trial of a novel anti-inflammatory drug (see story). IBI112 is a recombinant anti-interleukin 23p19 subunit antibody injection that is aimed at psoriasis, inflammatory bowel disease (IBD) and other autoimmune diseases. The trial will evaluate the safety and tolerability of the candidate in addition to PK/PD when IBI112 is administered as a single subcutaneous or IV dose in healthy individuals.

Disclosure: none.