Deals and Financings
Innovent Biologics has priced its Hong Kong IPO to raise $421 million, very close to the top of the expected range. The company set its offering price at HK$13.98, just below the top of the range. The successful IPO shows investors are still interested in young China biopharmas, even though the three earlier pre-revenue biotech IPOs in Hong Kong saw their prices slide lower once they began trading. The IPO values Innovent at $2 billion; its shares will begin trading in one week, on October 31.
China Everbright Limited, a Hong Kong firm, held its first closing of $155 million for the third iteration of its life science investment vehicle, Everbright Medical & Healthcare Fund III. The company expects its third fund to eventually raise $216 million. The first closing brings the total assets of Everbright's three healthcare funds to $432 million. Everbright invests over all stages of companies involved in pharma-biotech, health services, medical consumables, devices and equipment. It also participates in restructurings of China stage-owned enterprises.
XtalPi, a Boston-Shenzhen startup, raised $46 million in a second B round tranche, to develop its computer-driven drug research services. XtalPi says it combines quantum physics, artificial intelligence and cloud computing to improve pharmaceutical research. The new funding was led by China Life Healthcare Fund. XtalPi says its Intelligent Digital Drug Discovery and Development (ID4) platform provides accurate predictions on the physiochemical and pharmaceutical properties of small-molecule candidates for drug design.
Xgene Pharma, a Shanghai start-up, raised $20 million in series B financing round led by Ping An Ventures. Xgene's lead product, a combination of naproxen and pregabalin (Lyrica®) for chronic pain, is in Phase II trials in the US. Founded in 2016, Xgene Pharma develops small-molecule drugs for chronic pain, infectious diseases and tumors. Also participating in the funding were Zhongtai Investment, a subsidiary of Indonesia's Sinar Mas Group, and existing investors Morningside Venture Capital and TF Capital.
Shanghai Fosun Pharma (OTCPK:FOSUY) (HK:02196) (SHA:600196) will invest $10 million into Glycotest, a New York City company that is developing non-invasive diagnostic tests for early stage hepatocellular carcinoma (HCC), liver fibrosis and cholangiocarcinoma (bile duct cancer) (see story). Fosun will own 40% of Glycotest after it completes its investment and will have rights to market Glycotest's HCC panel in China, paying a royalty. Fosun will make an upfront payment of $3 million and milestone payments for the remaining $7 million.
CANbridge Pharma of Beijing and WuXi Biologics (HK:2269) announced a strategic partnership to develop new treatments for rare diseases. The partnership combines WuXi Biologics' (OTCPK:WXXWY) discovery, development and manufacturing capabilities with CANbridge's expertise in clinical development of orphan drugs. CANbridge expects to file the first China rare disease IND application from the partnership in 2019. WuXi Biologics will receive upfront payments, plus potential milestones and royalties on global sales for the partnership's programs.
WuXi AppTec (SHA:603259), China's largest CDMO, formed a big data JV with China Electronics Data Service Co. that will gather hospital medical and prescription data. The JV, which will be called CW Data, plans to provide real world data on China's use of medicines. The two companies said the JV will provide services that range from drug discovery and development to post-marketing drug efficacy evaluation and drug distribution. The JV will use CECD's National healthcare big data platform and protect patient privacy.
Trials and Approvals
Zai Lab (NASDAQ:ZLAB) of Shanghai was approved in Hong Kong to market Zejula® (niraparib), an oral, once-daily PARP inhibitor for adult ovarian cancer patients (see story). The approval of Zejula was based on the global Phase III trial of Zejula sponsored by Tesaro. Zai in-licensed China rights (including Hong Kong) to the drug from Tesaro in 2016. It is Zai's first marketing approval, and the company expects to launch Zejula before the end of the year. Zai is continuing to conduct China trials of Zejula.
Green Valley Pharma of Shanghai announced positive results from the Phase III trial of GV-971, its oral carbohydrate treatment for Alzheimer's disease, at a recent scientific meeting in Barcelona. In the trial, GV-971 produced a 2.54 improvement in ADAS-Cog12 scores over placebo, a statistically significant difference. The trial enrolled 818 patients with mild-to-moderate Alzheimer's. Last week, the company filed for China New Drug and Marketing Approval of GV-971, which was developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Suzhou Alphamab Oncology and 3D Medicines of Shanghai have started China Phase III trials of their novel fusion anti-PD-L1 antibody in patients with bile tract carcinoma. The candidate is also in a China Phase II trial for MSI-H solid tumors. According to the companies, KN035 is a first-in-class PD-L1 single-domain antibody with the unique advantages of subcutaneous injection and good stability at room temperature. So far, more than 300 patients have participated in KN035 clinical trials in the United States, Japan and China.
CStone Pharma of Suzhou received permission for US clinical trials of its novel PD-1 mAb, CS1003. One week ago, CStone announced a US approval to start a trial of another immuno-oncology candidate, its PD-L1 molecule, CS1001. Both candidates are full-length, humanized immunoglobulin G4 (IgG4) mAbs, and both showed good tolerability and efficacy in preclinical studies. In May, CStone began a Phase I trial of the PD-1 candidate in Australia. The Phase I trials will determine the Phase II dose for CS1003 in solid tumor patients.
CASI Pharma (NASDAQ:CASI), a Maryland-Beijing biopharma, acquired a US FDA-approved abbreviated new drug application from Laurus Labs of India, for tenofovir disoproxil fumarate (TDF), a first-line treatment for hepatitis B (see story). CASI will use the ANDA to apply for approval of the generic drug in China. China is home to 90 million people with HBV, one-third of the world's total. CASI will make upfront and milestone payments to Laurus, though details were not disclosed.
Jiangsu Hengrui Medicine (SHA:600276) and LSK BioPharma of Salt Lake City announced a global test that combines Hengrui's PD-1 candidate with LSKB's rivoceranib, a VEGFR-2 inhibitor, as a treatment for hepatocellular carcinoma. Hengrui's PD-1 mAb, camrelizumab, is currently under NDA review in China for classic Hodgkin's Lymphoma. Hengrui also owns China rights to rivoceranib, where it is available as Aitan® as a treatment for gastric cancer. LSKB holds ex-China rights to the drug.
Reistone Biopharma, a Shanghai startup, announced FDA approval to start a US Phase II clinical trial of a Janus Kinase 1 inhibitor (JAK1) in patients with ulcerative colitis. Reistone said the approval is a first step towards a simultaneous clinical testing of the candidate in China, the US and several EU countries. Reistone in-licensed the JAK1 inhibitor from Jiangsu Hengrui (SHA:600276), which also backs Reistone. Formed in January 2018, Reistone focuses on globalizing innovative drugs developed in China by companies like Hengrui.
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