China Pharma News Roundup May 11th 2020


Top recent news from Chinese pharma, including listings on the Hong Kong Stock Exchange, Junshi’s out-licensing of a potential COVID-19 treatment to Lilly, and Ascentage being granted US FDA orphan drug status for its leukaemia candidate.


Hong Kong IPOs Pick Up the Pace as China Restarts

Initial public offerings are picking up the pace in Hong Kong after two wildly successful biotech listings improved sentiment in the financial hub.

Even though the city’s benchmark Hang Seng Index has rebounded somewhat from its March low, firms have raised only $2.27 billion through first-time share sales since January, just over half of the amount in the same period last year, data compiled by Bloomberg show. But the listings of biotech companies InnoCare Pharma Ltd. and Akeso Inc. have shown the market is still open, especially for the health-care sector.


Junshi Out-Licenses Ex-China Rights for COVID-19 mAb to Eli Lilly

Junshi Biosciences (HK: 1877) out-licensed ex-China rights for a therapeutic antibody aimed at prevention and treatment of COVID-19 to Eli Lilly (NYSE: LLY). JS016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and blocks the binding of viruses to host cell surface receptor ACE2. The antibody research was developed jointly by Junshi and the Institute of Microbiology, Chinese Academy of Science.

Lilly plans to file an IND and start trials in the US in Q2 of 2020. Junshi retains all China rights to the candidate. Lilly will have an exclusive license to conduct clinical development, manufacturing and distribution of JS016 outside of Greater China.


Ascentage Granted US Orphan Drug Status for Leukemia Candidate

Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (US FDA) has granted HQP1351, the Company’s core drug candidate, an Orphan Drug Designation (ODD) for the treatment of chronic myeloid leukemia (CML).

This is the first ODD obtained by Ascentage Pharma. This ODD from FDA qualifies HQP1351 for various development incentives, including a tax credit of 50% of expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by FDA, and, most importantly, 7 years of US market exclusivity upon approval.


Chengdu-based Chinese biotech firm HitGen uses DNA to discover new drugs

HitGen listed on China’s STAR Board on April 16, raising some 118 million U.S. dollars. According to the company’s listing prospectus, 75 percent of its listing net proceeds will be used for a new molecular design, construction, and application platform construction project, with the remaining funds for a new drug research and development project. Li Jin, chairman and CEO of HitGen, said the company’s top priority is to continue to invest in its core technology – the DEL technology – to make progress in its drug discovery programs.

HitGen has collaborated with global pharmaceutical companies to help them discover and develop new medicines. Most recently, it signed licensing agreements with Mitsubishi Tanabe Pharma Cooperation, Kaken Pharmaceutical, and Janssen Biotech – one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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