The most encouraging news this week is that the international, multicenter, Phase III clinical trials of Hengrui's PD-1 combination therapy for liver cancer have been announced to be successful, and the company plans to start a conversation soon with the FDA for a potential new drug application. The review of this week is from May 6 to 14, covering 19 pieces of news in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA
Marketing
Approval
1. On May 6, NMPA's official website revealed that the marketing application of ACEA Pharma's avitinib maleate capsules is in the "in approval" stage, which is expected to get a review result in the near future. Avitinib is the first Chinese three-generation EGFR-TKI to be declared for marketing, and its application was submitted in June 2018. However, during the process of data supplementation, Hansoh Pharmaceutical Group's Almonertinib and Allist's Furmonertinib preempted the market.
2. On May 11, GSK announced the expanded indication of Dovato (dolutegravir/lamivudine) tablets, the single-pill two-drug regimen for the treatment of HIV patients, has been officially approved by NMPA. It is intended as a complete regimen for the treatment of HIV-1 adults and adolescents over 12 years old who have achieved virologic suppression.
Clinical
Application
3. On May 10, CDE's official website revealed that Qilu Pharmaceutical's clinical trial application for AB-729 injection, an RNA interference (RNAi) therapeutic agent targeting hepatocytes developed by Arbutus, was accepted. In December 2021, Qilu Pharmaceutical was granted the exclusive license for the development and commercialization of AB-729 in Greater China (including the Chinese Mainland, Hong Kong,, S.A.R, China, Macau, S.A.R., China, and Taiwan, China).
4. On May 10, CDE revealed that the JS203 clinical application of Junshi Biosciences was accepted. JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi, mainly for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma. Pre-clinical in vivo pharmacodynamics showed that JS203 has a significant anti-tumor effect. In addition, JS203 is well tolerated by animals.
5. On May 12, the clinical application of Pfizer's highly-selective CDK2 inhibitor PF-07104091 was first declared in China. The clinical trial of PF-07104091 was first initiated in August 2020, and two clinical trials have been registered by now. The first clinical trial is a Phase I/II clinical trial, exploring PF-07104091 combined with palbociclib for the treatment of multiple solid tumors, including triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and ovarian cancer.
Approval
6. On May 11, the CDE official website revealed that Genelux Corporation's Olvi-Vec injection was granted implied permission for a clinical trial, which is for the proposed indication of platinum-relapse/refractory small cell lung cancer. Olvi-Vec is an oncolytic virus immunotherapy product, which is currently in the preparation phase of Phase III registrational clinical trial overseas. Newsoara has interests in Greater China.
7. On May 12, the CDE official website revealed that Stone Pharma's CS5001 was clinically approved for advanced malignant neoplastic hematologic disorder and solid tumors. CS5001 is an antibody-drug conjugate (ADC) composed of a human monoclonal antibody targeting ROR1. In October 2020, Stone Pharma entered into a license agreement with LegoChem Biosciences, Inc. for the development and commercialization of CS5001.
Priority review
8. On May 11, CDE's official website revealed the marketing application of Yichang Humanwell Pharmaceutical’s generic drug, clobazam tablets will be included for priority review for the combined treatment of seizures in patients with Lennox-Gastaut Syndrome (LGS) aged 2 years and above. Clobazam is an effective drug for the treatment of rare epilepsy, and Yichang Humanwell Pharmaceutical is the first company in China to submit such an application.
FDA
Marketing
Application
9. On May 9, Biogen announced that its partner Eisai has completed the rolling submission to the FDA Biologics License Application (BLA) for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for the treatment of Alzheime...
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