Deals and Financings

BeiGene (NSDQ: BGNE; HK: 06160), a Beijing cancer biopharma, announced a blockbuster collaboration with Amgen (NSDQ: AMGN) that calls for Amgen to invest $2.7 billion into BeiGene while BeiGene agrees to develop and market 23 Amgen novel cancer candidates in China (see story). One of the drugs is already approved in China and two others are approved outside of China. In addition, BeiGene will be in charge of China development for 20 Amgen pre-clinical molecules. All together, BeiGene will set aside $1.2 billion for development costs of the candidates. It said the agreement will build its China marketing business while its own drugs move into commercialization. The $2.7 billion Amgen investment represents a 20.5% stake in BeiGene, valuing the company at $13 billion.

SinoMab Bioscience, a Hong Kong company that develops antibodies and immunotherapies for autoimmune diseases and cancer, will raise up to $223 million in a Hong Kong IPO (see story). The company’s lead candidate, SM03, is a global first-in-class mAb that is currently in a China Phase III trial for rheumatoid arthritis. SM03 targets CD22, a novel antigen found only on B cells. SinoMab expects to submit an NDA for SM03 by mid-2020. SinoMab began offering shares today and will continue until November 5, with trading starting on November 6.

I-Mab, a Shanghai biopharma, has filed to IPO on the NASDAQ Exchange with the goal of raising up to $100 million (see story). The company was formed in 2017 when Third Venture Biopharma merged with Tasgen Biotech and completed a $150 million initial funding, led by C-Bridge Capital and Shanghai Tasly Pharma. Currently, I-Mab is developing a portfolio of 11 biologics for oncology and inflammatory indications, including immunotherapies. Eight of its candidates are in clinical trials. In 2018, I-Mab closed a $220 million C financing, one of the largest ever for a China biopharma.

On its first day of trading following a Hong Kong IPO, Ascentage Pharma (HK: 6855) of Suzhou rose as much as 57% from its IPO price, but settled back to a 10% gain at the end of the session (see story). The price increase brings Ascentage's market cap to $1 billion. The company plans to use 42% of the $53 million IPO to support its lead drug, HQP1351, which targets BCR-ABL-mutations in chronic myeloid leukemia patients who are resistant to existing therapies. HQP1351 is in China Phase II trials and was recently approved to start a US Phase Ib trial as well.

Denovo Biopharma, a San Diego-Beijing company, closed a $42.6 million Series B round from China investors to support its personalized drug development operations (see story). The company applies its genomic biomarker discovery platform and algorithm retrospectively using archived clinical samples from drugs with low levels of efficacy or unacceptable safety issues. If it finds a promising situation, Denovo acquires rights to the drugs and conducts clinical trials in a more narrow patient population. The company in-licensed its two lead programs from Lilly (NYSE: LLY), one a treatment for and the other for glioblastoma multiforme. Both are in global Phase III trials.

Aesthetic Medical International Holdings (NSDQ: AIH), a Shenzhen aesthetics company, completed a $30 million IPO on NASDAQ (see story). AIH, also known as “Peng’ai” in China, is the third largest aesthetics service company by revenue in China, with 15 facilities in large China cities plus Hong Kong and Singapore. The IPO values AIH at $280 million. Founded over 20 years ago, AIH is more than 50% owned by Dr. Zhou Pengwu, CEO, and his wife. The ADSs, which were priced at $12 each, fell 16% to $10.03 in their first trading session.

QnQuality Pharmaceuticals of Shanghai-Seattle raised $15 million in a Series A funding led by Matrix Partners China and BioTrack Capital (see story). QnQuality is developing first-in-class drugs to treat side-effects of oncotherapy, especially a hand-foot skin reaction in cancer patients treated with VEGF drugs. OQL011 has been approved to start Phase II trials in the US. Also participating in the funding were CASH Capital, backed by state-owned Chinese Academy of Sciences Holdings Company.

Jiangsu QYuns Therapeutics agreed to out-license ex-China rights to its portfolio of six autoimmune disease mAb candidates to Seneca Biopharma (NSDQ: SCNA) of Maryland (see story). The agreement does not include any upfront, milestone or royalty payments, though presumably QYuns will manufacture the drugs for Seneca to commercialize. QYuns developed the products, which are mostly interleukin antibodies. using its novel rabbit-based discovery platform. After final agreement, Seneca's lead drug will be QYuns' QX005N, an IL-4Rα mAb aimed at asthma and atopic dermatitis that has a potential market in the US of $1 billion.

Yixi Biotech of Nanjing has completed an angel round of several million dollars to support its portfolio of treatments for intestinal microbial diseases, starting with reconstructing bacteria after chemotherapy (see story). The company will use the financing's proceeds for R&D of alternative treatment protocols, synthetic biological strains and drugs that treat intestinal microbial diseases. Founded earlier this year, Yixi Biotech aims to manage intestinal microorganisms so that people can have healthy intestinal microbial communities and avoid metabolic diseases.

Trials and Approvals

Ansun Biopharma, a San Diego anti-infectives company, announced two clinical trial approvals in China for its novel anti-infective, DAS181: a China extension of Ansun's global Phase III DAS181 trial for hospitalized, immunocompromised patients with lower respiratory tract parainfluenza virus infection, and a Phase IIb trial to treat severe hospitalized influenza infection (see story). In the last 18 months, Ansun has raised $165 million to support parallel development of these two trials around the globe. The company noted there are no approved drugs to treat either condition in patients who do not respond to the standard of care.

Visen Pharma of Shanghai reported that China approved its IND to start a Phase III trial for TransCon human growth hormone in patients with childhood growth hormone deficiency (GHD) (see story). Visen was formed last year by Sweden's Ascendis Pharma and an investor syndicate that provided $40 million in capital, led by Vivo Capital. The company will develop Ascendis' portfolio of three endocrinology rare disease therapies in Greater China. Visen believes TransCon hGH, a long-acting drug that offers once-weekly dosing, will be the first long-acting growth hormone therapy available in China.

Terns Pharma, a Shanghai-San Francisco biopharma, announced that TERN-101, a farnesoid X receptor (FXR) agonist, was granted Fast Track Designation by the US FDA to treat NASH (see story). In 2018, Terns in-licensed global rights to TERN-1, together with a second NASH candidate, from Eli Lilly. Lilly Asia Ventures also invested $30 million in Tern at the same time. In preclinical testing, TERN-101 reduced liver steatosis, inflammation, ballooning and fibrosis in a NASH model. Phase I pharmacokinetics were consistent with once-daily dosing.

Disclosure: none.

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