Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical officer at E-nitiate Biopharma. “The first step is to enter China’s autoimmune skin diseases market.”
Shanghai Junshi Biosciences Co. Ltd. plans to raise up to ¥3.969 billion (US$570 million) by issuing no more than 70 million A shares to target subscribers on the Shanghai STAR Market.
Investments in early stage biotech companies were in focus at the Hong Kong Stock Exchange’s (HKEX) Biotech Summit 2022. The virtual event on Sept. 1 saw discussions centered on this investment trend for younger biotech firms, which looks to be where capital is headed in the sector after a cooldown for listings in Chinese stock markets in the first half of 2022.
Biocytogen Pharmaceuticals Co. Ltd. has raised HK$471.1 million (US$60 million) in net proceeds through an initial public offering on the Hong Kong Stock Exchange Sept. 1. It plans to use about three-quarters of the proceeds to advance clinical trials of two of its core anticancer candidates, YH-003 and YH-001. Company shares (HKEX:2315), initially offered at HK$25.22 each, closed at HK$26 on their first trading day.
Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
China has upheld a recent ruling on a dispute between Chugai Pharmaceutical Co. Ltd. and Wenzhou Haihe Pharmaceutical Co. Ltd. over a generic form of an osteoporosis treatment. The move is seen as an indicator that patent protection for drugs has improved in China.
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino.
For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets.
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