Over 50 Domestic Class 1 Innovative Drugs Poised for Market Launch in Q4, Including Candidates from Corrozone Pharma, Legend Biotech, and CARsgen

　　【Pharmaceutical Network Product Information】 Currently, favorable policies for the innovative drug sector in China are being continuously released, and the R&D technology of major pharmaceutical companies is also improving. The innovative drug market is welcoming a high-speed development opportunity. According to relevant data, the scale of China's innovative drug market reached 678.5 billion yuan in 2022, and it is expected that the scale of China's innovative drug market will grow to 778.9 billion yuan in 2023.
 

Driven by policy and market forces, the innovation and R&D enthusiasm of Chinese pharmaceutical companies has been ignited, with continuous breakthroughs in domestically produced Class 1 innovative drugs. As we enter the fourth quarter of 2023, data predicts that 54 China-produced Class 1 new drugs may be launched in the market during this period. Companies involved include Shanghai Kechow Pharma, Inc., Legend Biotech, Juventas, and CARsgen Therapeutics, Ltd.
 

On February 10, the CDE website showed that the MEK inhibitor Tolorametinib Capsules (HL-085) from Shanghai Kechow Pharma, Inc. were included in the priority review as a "drug eligible for conditional approval," for the treatment of patients with advanced melanoma carrying NRAS mutations who have previously received immunotherapy.
 

Data show that HL-085 is a novel ATP non-competitive MEK inhibitor targeting NRAS mutations. Compared with traditional MEK inhibitors, the advantage of HL-085 lies in its lack of accumulation. In a Phase I clinical trial in China, it demonstrated promising efficacy in melanoma patients with NRAS mutations. Industry experts note that NRAS-mutant melanoma is highly malignant, has a poor prognosis, and lacks effective treatment options. Currently, there are no globally approved targeted drugs for this condition, underscoring the urgent clinical need to develop effective therapies.
 

Legend Biotech's Cilta-cel (Ciltacabtagene Autoleucel) had its marketing application in China accepted by the Center for Drug Evaluation (CDE) on December 30, 2022. This drug is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA) and was approved in the United States in February 2022. It received conditional approval from the European Commission in May of the same year and was approved by Japan’s Ministry of Health, Labour and Welfare four months later for the treatment of adult patients with relapsed or refractory multiple myeloma.
 

In addition, in January 2023, Legend Biotech announced that the evaluation showed the phase 3 study CARTITUDE-4 of CARVYKTI (Ciltacabtagene Autoleucel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma had reached its primary endpoint. That is, for the first round of pre-specified interim analysis of this study, compared with standard therapy, progression-free survival (PFS) was significantly improved statistically. Based on the recommendation of the clinical trial data monitoring committee, the study has been unblinded.
 

On December 15, 2022, the marketing application for Juventas' CAR-T therapy (Chimeric Antigen Receptor T-Cell Immunotherapy) targeting the CD19 antigen, Hercloncell Injection, was accepted by the National Medical Products Administration (NMPA) and proposed for priority review and approval. It is intended for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Currently, no CAR-T therapy for this indication has been approved in China.
 

Juventas' Hecarlun Cell Injection is the first CAR-T cell therapy product in China's leukemia treatment field to have its new drug application accepted and is expected to be the first approved. It also has the potential to become the first approved fully self-developed Chinese CAR-T cell therapy product targeting CD19.
 

On October 18, 2022, CARsgen Therapeutics announced that the China National Medical Products Administration (NMPA) has accepted the new drug application for the marketing of Zevor-cel Injection (R&D code: CT053). Data shows that Zevor-cel Injection is a fully human anti-BCMA autologous CAR-T cell candidate product intended for the treatment of relapsed/refractory multiple myeloma. Recently, the drug has been proposed by the CDE for inclusion in the priority review.
 

Currently, CARsgen Therapeutics is conducting a Phase 1b/2 clinical trial in North America to evaluate the safety and efficacy of Zevor-cel (Zevorcabtagene Autoleucel) Injection for the treatment of relapsed/refractory multiple myeloma. In 2019, Zevor-cel received the Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. FDA.
 

As China-produced Class 1 innovative drugs get approved for marketing, patients will also have more medication options. According to data statistics, since the beginning of this year, over 60 Class 1 new drugs (including imported new drugs, but excluding improved new drugs) have been approved for marketing in China, far surpassing the number in 2022.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.