publication date: Oct 24, 2020
author/source: Richard Daverman, PhD
Deals and Financings
India's Gland Pharma, a majority-owned subsidiary of Shanghai Fosun Pharma (SHA: 600196; HK: 2196), was approved for an $814 million IPO on India's Sebi exchange (see story). The Hyderabad-based drug company makes generic injectible drugs for international markets. In 2017, Fosun paid $1.1 billion for a 74% stake in Gland. About $170 million of the IPO will be company shares, while $644 million will go to existing shareholders, a combination of Fosun and long-term investors including the founding family.
Huadong Medicine (SHZ: 000963) in-licensed greater China rights to an antibody-drug conjugate developed by ImmunoGen (NSDQ: IMGN) in a $305 million agreement (see story). IMGN853 (mirvetuximab soravtansine) is in a US Phase III trial for platinum-resistant ovarian cancer, with data expected in 2021. Huadong will pay $40 million upfront and up to $265 million in milestones. Its subsidiary, Hangzhou Zhongmei Huadong Pharma, will be in charge of China development.
3D Medicines, a Beijing clinical-stage biopharma, completed a $225 million funding (see story). Two years ago, 3DMed spun off its diagnostics business into 3D Diagnostics and now concentrates on development of immunotherapy drugs. In 2017, 3DMed agreed to conduct the clinical trials and commercialization of Alphamab's envafolimab (KN035), a subcutaneous injection PD-L1 checkpoint inhibitor. The candidate has started clinical trials in China, the US and Japan. The company's funding was co-led by China Capital Management and Efung Capital, a biomedical venture capital firm.
Sirnaomics, a US-China company developing RNAi therapeutics, closed a $105 million Series D round from China investors (see story). The company is developing a portfolio of novel RNAi therapeutics that address a range of diseases including various cancers, fibrosis diseases, metabolic diseases and viral infections. Earlier this year, it announced positive interim results from a Phase IIa study of STP705 for Cutaneous Squamous Cell Carcinoma in-situ. Siranomics, which plans to conduct an IPO in the near future, is headquartered in Maryland, with China operations in Suzhou and Guangzhou.
Zhaoke (Hong Kong) Ophthalmology Pharma acquired Greater China rights to a myopia treatment from Nevakar in a $102 million agreement (see story). NVK-002 is a novel topical treatment aimed at slowing the progression of myopia in children. It is currently being tested in a US-EU Phase III clinical trial. ZKO's parent, Zhaoke Ophthalmology, raised $50 million in a Series A last year and closed a $145 million Series B recently. Zhaoke is described as an indirect non-wholly-owned subsidiary of China in-licensing company Lee's Pharm.
Beijing Immunochina Pharma raised $15 million in C+ round of financing to support its portfolio of 12 CAR-T candidates (see story). Established in 2015, Beijing Immunochina has developed a serum-free production process and large-scale gene vector production platforms to improve the safety and efficacy of CAR-T products. It has started clinical trials for one CAR-T candidate, IM19, that it is co-developing with China's Simcere Pharma for leukemia and non-Hodgkin's lymphoma.
Four China biopharmas have dosed a total of 60,000 people in Phase III trials of their respective COVID-19 vaccines without causing any serious adverse reactions (see story). The news did not include any reports on the vaccines' efficacy, which must wait for more data. At a news conference, Zheng Zhongwei, head of China’s COVID-19 vaccine development task force, said China is expected to produce as many as 610 million vaccine doses by the end of this year.
Carelink, a Shanghai pharma founded in 2018, acquired China rights from Japan's FujiFilm for Avigan® Tablets (favipiravir), a flu drug, to treat COVID-19 (see story). Favipiravir is approved in several markets for the coronavirus, though not in the US or EU. Carelink will use FujiFilm's nonclinical and clinical data on Avigan for flu and COVID-19 as the basis for China approval of the drug. The two companies will also work together to develop an injectable form of Avigan.
Trials and Approvals
Suzhou Ascentage Pharma (HK: 6855) reported its New Drug Application for Olverembatinib (HQP1351) will be reviewed under priority status in China (see story). According to Ascentage, Olverembatinib is a third-gen BCR-ABL inhibitor because it is able to overcome resistance caused by tyrosine kinase mutations, especially T315I-caused resistance. Olverembatinib, which was tested in patients with T315I-mutant chronic CML and accelerated CML, is Ascentage's first China NDA submission.