HONG KONG The biotech sector in greater China ended the financial year on a high note. Companies on the Hong Kong Stock Exchange reported better-than-expected results, including seven pre-revenue startups that went public over the last year, adding to the energy in the biotech space.
HONG KONG – The late December IPO of Shanghai Junshi Biosciences Co., shortly after the company got a green light for the first made-in-China immunotherapy treatment, delivered a strong close to 2018 for the country's biotech industry. But it did little to mask the huge losses that Chinese pharma stocks suffered through the year.
In a second first in the same week for China, roxadustat (previously FG-4592), developed by Fibrogen Inc. and partnered in the country with Astrazeneca plc, became the first drug advanced by a global biopharma to receive its initial nod from the National Medical Products Administration (NMPA, formerly the CFDA) before applications were submitted to the FDA and EMA. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) was approved to treat anemia caused by chronic kidney disease (CKD) in patients who are dialysis dependent (DD) and use either hemodialysis or peritoneal dialysis.
HONG KONG – China has seen a busy month of drug approvals, from Lenvima (lenvatinib, Eisai Co. Ltd. and Merck & Co. Inc.) on Sept. 5 to Elunate (fruquintinib, Hutchison China Meditech Ltd.) and Soliris (eculizumab, Alexion Pharmaceuticals Inc.) on Sept. 6. More notably, the three drugs, all accepted under the priority review pathway, were granted marketing approval in about a year.
HONG KONG – Amid renewed interest in CD47 as an immuno-oncology target, Innovent Biologics Inc., of Suzhou, China, has received IND approval in China to start clinical trials of its monoclonal antibody (MAb), IBI-188. To further get ahead in the anti-CD47 race, Innovent will conduct clinical trials on IBI-188 at home and abroad simultaneously.
Despite the fact that the industry inked more than 1,000 deals last year, it appears that biopharma companies are not losing their appetite for dealmaking. According to data from BioWorld and Cortellis Deals Intelligence, there were 271 deals signed in the first quarter of 2018, on par with 2017 first quarter transactions.
HONG KONG – Less than two months after picking up a big win with the FDA approval for Mylan NV-partnered Herceptin biosimilar Ogivri (trastuzumab-dkst), India's Biocon Ltd. inked a deal with another leader in biosimilar development, Sandoz Inc., a division of Novartis AG, to develop, manufacture and commercialize multiple products in the areas of immunology and oncology.
HONG KONG – With a series of advancements in the area of biosimilar development, China's Shanghai Fosun Pharmaceutical Group Co. Ltd. is getting closer to becoming the first domestic company to market a biosimilar product in China. Fosun Pharma said its subsidiary, Shanghai Henlius Biotech Inc., has received a notice from the CFDA that its first marketing application, for a biosimilar rituximab, is officially under review.