This week, in terms of drug review and approval, three pieces of news are particularly worthy of attention: Humanwell Healthcare's first generic drug of oxycodone hydrochloride sustained release tablets were approved for marketing; Zelgen Biopharmaceuticals' Jaktinib, the first JAK inhibitor made in China, was declared for marketing; and LEGN.US' Cilta-cel, a BCMA CAR-T cell therapy, was approved in Japan. In terms of R&D, Eisai and Biogen announced positive results from the Phase III trial of Lecanemab to treat Alzheimer's disease (AD); There is also some news worthy of attention in terms of business and policy.
Drug Review
NMPA – Marketing
[Approval]
1. On September 28, the NMPA official website revealed that Humanwell Healthcare's oxycodone hydrochloride sustained release tablets had been approved for marketing, intended for the first-line treatment of moderate to severe cancer pain. Oxycodone hydrochloride is a pure opioid receptor agonist with relative selectivity to μ receptor, able to combine with other opioid receptors to treat pain at higher doses. Humanwell Healthcare thus became the first pharmaceutical company to produce a generic drug of oxycodone hydrochloride sustained-release tablets.
2. On September 29, the NMPA official website revealed that the new indication of Lepu Biopharma's Pucotenlimab monoclonal antibody injection had been conditionally approved for marketing, intended for the treatment of patients with unresectable or metastatic melanoma who had failed systemic treatment in the past. Pucotenlimab is a humanized IgG4 monoclonal antibody against PD-1.
NMPA – Marketing
[Application]
3. On September 27, the CDE official website revealed that the marketing application for the new indication of Pfizer's Crisaborole Ointment had been processed, presumably intended for atopic dermatitis in adults and children aged 3 months and above. Developed by Anacor, Crisaborole is a small-molecule, non-hormonal, non-steroidal anti-inflammatory...
(All Rights Reserved)