Hong Kong IPOs 

Mabpharm Limited, a Taizhou biotech, will IPO in Hong Kong, the eleventh pre-revenue China biopharma to be approved to list there (see story). Mabpharm is developing a portfolio of nine biosimilars, which it hopes will prove to be biobetters. Three of the candidates are in Phase III trials. They were initially discovered by Sinomab, which spun out Mabpharm to develop the drugs, while Sinomab continues to focus on its CRO/CMO operations. Mabpharm intends to make manufacturing of biologic drugs part of its business as well. CDH Investments has backed the company and currently holds 22% of its shares.  

Ascentage Pharma of Suzhou has been approved to stage a Hong Kong IPO (see story). The company, which has built a portfolio of seven clinical stage small-molecule candidates, bases its drug discovery on an expertise in protein-protein interactions (see story). Its seven candidates are currently being tested in 20 Phase I and II trials in China, the US and Australia. One month ago, Ascentage raised $150 million in a Series C funding, bringing its total venture backing up to $240 million.  

Zai Lab (NSDQ: ZLAB) is planning to list its shares on the Hong Kong exchange, according to unnamed sources, in a transaction that could raise up to $300 million (see story). One year ago, the company completed a $172 million NASDAQ debut offering. Zai is following the lead of BeiGene (NSDQ: BGNE), which raised $900 million in Hong Kong after initially listing on NASDAQ. The Zai transaction is expected to be 10% to 20% of its expanded share base; it currently has a market capitalization of $1.2 billion.  

Deals and Financings  

China Biologic Products (NSDQ: CBPO), a Beijing blood products company, rejected a $3.9 billion management-led privatization offer, and will instead accept a $590 million private equity investment, led by a investment firm associated with management (see story). The management-led privatization was a response to CITIC's offer to buy CBP for $3.6 billion. Following the higher bid from management, CITIC withdrew its offer and CBP's board rejected the management privatization. CBP dropped $15.62 (15.5%) to $85.28 on news the takeover won't happen.  

Harbour BioMed acquired global rights (ex-China) to a PD-L1 candidate from Sichuan Kelun-Biotech in a deal worth up to $350 million (see story). Kelun-Biotech is currently testing A167 (KL-A167) in several China Phase I and II trials among patients with lymphoma and solid tumors. Harbour plans to conduct A167 trials in combination with its own innovative compounds and in collaborations with partners' drugs. Harbour has an R&D site in Shanghai, headquarters in Boston and an antibody discovery operation in Holland.

Harbin Gloria Pharma (SZE: 002437) restructured its development program by forming a $53 million consortium with four investors (see story). The consortium will have rights to four Gloria development-stage assets. 6 Dimensions, Boyu Capital and two other investors will acquire a 51% stake in Guangzhou Gloria Biotech for $27 million. Gloria will invest $26 million for the remaining 49%. The new subsidiary will be in charge of development of the four assets, including a PD-1 clinical stage candidate.

Oxford Biodynamics PLC (LON: OBD) raised $12.5 million from GL Capital Group, a Shanghai private equity investor with a healthcare focus (see story). OBD uses a proprietary platform, EpiSwitch™, to develop biomarkers based on chromosome conformation signatures, which allow early identification of disease-causing changes. GL Capital, which will own a 5% stake in Oxford Biodynamics, will be in charge of finding China partners for OBD's products/services.  

Trials and Approvals 

Jiangsu Hengrui Medicine (SHA: 600276) was awarded China approval of a novel treatment for HER2-positive cancer as a second-line therapy (see story). Pyrotinib, a dual EGFR/HER2 dual tyrosine kinase inhibitor, was conditionally approved after it improved Overall Response Rate and more than doubled Progression-Free Survival in a Phase II trial in patients with HER2-positive breast cancer. China conducted a priority review of the drug. Hengrui has already started a China Phase III trial of pyrotinib in the same patient population and an early US trial in solid tumors.  

Roche (VX: ROG) received marketing authorization from the China National Drug Administration for Alecensa (alectinib) as a first-line treatment for ALK-positive non-small cell lung cancer (see story). The company noted the approval came just eight and nine months after EU and US approvals, a speedy priority review process. Alecensa more than tripled progression-free-survival in Phase III trials, compared to Xalkori (crizotinib), a Pfizer (NYSE: PFE) drug. 

Bio-Thera Solutions of Guangzhou said its Biologics License Application for a Humira biosimilar was accepted for review by the China National Drug Administration (CNDA) (see story). Humira (adalimumab) is used to treat arthritis, psoriasis and other autoimmune disorders. As part of its filing, Bio-Thera presented data from a PK/PD trial, and a Phase III confirmatory safety/efficacy study in ankylosing spondylitis. Bio-Thera's filing is the first adalimumab biosimilar BLA accepted for China review. 

Company News 

Bristol-Myers Squibb (NYSE: BMY) will set the China price of Opdivo, its PD-1 lung cancer treatment, at half the US price, according to news sources (see story). The US price is roughly $150,000, but the China price will be a still-high $84,000, which would make Opdivo one of the most -- if not the most -- expensive drugs in China. BMY expects to launch the drug in China before the end of September.

Disclosure: none.