Recent Advances in Drug Development and Approvals by Multiple Pharmaceutical Companies

　　【Pharmaceutical Network Industry DynamicsOn October 8, Everest Medicines announced that the new antibacterial drug Eravacycline (Xerava) has been approved for marketing in Hong Kong, China, for the treatment of complicated intra-abdominal infections in adults. Eravacycline was developed by Tetraphase (a wholly-owned subsidiary of La Jolla), and Everest Medicines holds the exclusive rights for the development and commercialization of the drug in Greater China, South Korea, and several key Southeast Asian markets.
 

It is reported that the indication approved for this drug in the Hong Kong region of China is also complicated intra-abdominal infections in adults. In addition, the marketing applications for Eravacycline targeting this indication are under review in mainland China and Taiwan.
 

On October 6, Provention Bio announced an agreement with Sanofi to jointly advance the commercialization of teplizumab. Previously, the FDA had accepted the Biologics License Application (BLA) for teplizumab to delay the onset of Type 1 diabetes in high-risk individuals, setting the PDUFA date for November 17, 2022. This also indicates that, if all goes well, the drug is expected to be approved next month.
 

On October 5, GSK announced that its PD-1 monoclonal antibody Jemperli (dostarlimab) in combination with chemotherapy demonstrated positive topline results compared head-to-head with Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC) in the Phase II PERLA trial, meeting the primary endpoint. Detailed results will be presented at an upcoming meeting. Data show that Jemperli is a humanized anti-PD-1 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.
 

In fact, entering 2022, there has been a constant stream of news about new drug approvals and clinical trial authorizations. According to the Insight database, just last week (September 19th to September 25th), in China, 53 innovative drugs (including improved new drugs) such as Junshi Biosciences' Toripalimab and RemeGen's Telitacicept made new progress in their development. Among them, 20 drugs received clinical trial approval, involving several innovative drugs being authorized for clinical trials for the first time.
 

In addition, according to data statistics from the National Medical Products Administration and the Center for Drug Evaluation under the National Medical Products Administration, as of October 5, 2022, 14 major innovative drugs have been approved for marketing. Among them, several innovative drugs produced by Chinese pharmaceutical companies have been approved, such as the Omutigevimab Injection from North China Pharmaceutical, Tazverik from CStone Pharmaceuticals, and Duvrilisib Capsules from CSPC Pharmaceutical Group.
 

The industry believes that, from the above, it is clear that innovative drugs have become a key focus for companies in the sector. As a result, a large number of pharmaceutical companies are expected to continuously achieve new progress in the commercialization/research and development of new drugs. Especially against the backdrop of China's vast pharmaceutical market, which is increasingly attracting the attention of more multinational pharmaceutical companies, there may also be an increasing number of pharmaceutical companies actively promoting the launch of new drugs in China to benefit more patients.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.