NMPA Approves Five New Drugs for Clinical Trials from Eli Lilly, Roche, Hengrui, Janssen, and Servier

On March 13, the CDE website showed that five new drugs from five companies were approved for clinical trials, namely Tirzepatide Injection (Eli Lilly), SHR2150 Injection (Hengrui), RO7234292 Injection (Roche), Guselkumab Injection (Janssen), and Irinotecan Liposome Injection (Servier).

Tirzepatide Injection

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist developed by Eli Lilly. The drug has currently been approved for three clinical trials in China, namely: 1) type 2 diabetes; 2) long-term weight management in patients with overweight or obesity; and 3) type 2 diabetes with high cardiovascular risk.

Furthermore, tirzepatide has also demonstrated certain therapeutic potential for non-alcoholic steatohepatitis (NASH). In its 2019 report, the renowned investment firm EvaluatePharma listed it as one of the most valuable investment opportunities.

SHR2150 Injection

SHR2150 is a Class 1 new drug developed by Hengrui, available in two formulations: capsules and injection. The SHR2150 capsule received implicit clinical trial approval for advanced malignant tumors in December 2018. Now, the SHR2150 injection has also been approved for clinical trials to treat advanced/metastatic malignant tumors.

RO7234292 Injection

RO7234292 (RG6042) is an antisense oligonucleotide (ASO) developed by Roche, with Huntington’s disease as the intended indication. The drug aims to reduce the production of the pathogenic protein, namely toxic mutant huntingtin (mHTT), in patients with Huntington’s disease by targeting human huntingtin RNA.

Guselkumab Injection

Guselkumab is a fully humanized monoclonal antibody targeting interleukin-23 (IL-23), developed by Janssen. It was approved in China on December 27, 2019, for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The clinical trial approval obtained this time for Guselkumab injection is for the indication of moderate-to-severe active Crohn's disease.

Irinotecan Liposome Injection

Liposomal irinotecan hydrochloride injection is a topoisomerase I inhibitor encapsulated within phospholipid bilayer vesicles, or liposomes. It was co-developed by Merrimack and Servier. The clinical trial approval obtained this time is for use in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic pancreatic cancer who have progressed following gemcitabine-based therapy. This indication was approved by the FDA on October 22, 2015.