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 Alzheimer's disease. Lecanemab was co-developed by Eisai and BioArctic. As part of the completed rolling submission, Eisai has requested Priority Review.

R&D

Launching the clinical trials

10. On May 10, a press conference was held in Uzbekistan for oral COVID-19 drug VV116 of Junshi Biosciences/Vigonvita. VV116 is an oral drug for COVID-19 with the fastest development progress in China, and its international, multi-center, Phase III clinical trials are actively advancing, including a head-to-head Phase III clinical trial of Pfizer's Paxlovid. The patient enrollment has been completed.

11. On May 12, Shanghai Zhimeng Biopharma announced the dosing of the first participant in the US Phase I study in healthy subjects of its innovative small-molecule KCNQ2/3 selective opener (CB03), developed for the treatment of refractory epilepsy. Independently developed by Zhimeng Biopharma, CB03 is Zhimeng’s first drug candidate to enter clinical trials in the field of central nervous system disorders.

12. On May 12, the drug clinical trial registration and information publicity platform of CDE revealed that the clinical trials of Simcere Pharmaceutical’s oral protein-arginine methyltransferase 5 (PRMT5) inhibitor (SCR-6920) were initiated for treating advanced malignant tumors. SCR-6920 is highly selective and potent for PRMT5 activity inhibition and exhibits proliferation inhibitory activity against a variety of hematologic and solid tumor cells in vitro.

Clinical data release

13. On May 10, CARsgen announced the interim results of the investigator-initiated trial of CT041 were published in Nature Medicine, which is one of the top international medical academic journals. CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on gastric cancer/esophagogastric junction adenocarcinoma (GC/GEJ) and pancreatic cancer.

14. On May 11, Roche announced the interim results of its Phase III SKYSCRAPER[RH6] -01 clinical trial, evaluating the investigational anti-TIGIT immunotherapy tiragolumab in combination with PD-L1 monoclonal antibody Atezolizumab as a first-line treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer NSCLC. The study failed to reach the co-primary endpoints of progression-free survival (PFS) and the other co-primary endpoint of overall survival (OS) was immature.

15. On May 12, Hengrui Medicine announced that the international multicenter Phase III clinical trial of camrelizumab combined with apatinib mesylate for the first-line treatment of hepatocellular carcinoma (SHR-1210-III-310) was determined by the Independent Data Monitoring Committee (IDMC) that the primary endpoint of the study met the protocol-preset superiority standard. The results demonstrated that camrelizumab combined with apatinib compared with sorafenib as first-line treatment could significantly prolong progression-free survival (PFS) and overall survival (OS) in patients with advanced hepatocellular carcinoma.

Business

16. On May 9, Reistone Biopharma announced the completion of a Series A financing round valued at nearly US$ 100 million, co-led by the medical fund under Huagai Capital and Capital Healthcare Fund managed by it. Reistone Biopharma was co-founded by Hengrui in early 2018 with a US$ 100 million investment, and its four drugs in development are all national Class I new drugs. Currently, several clinical trials are underway, four of which have been in the Phase III clinical stage.

17. On May 10, Pfizer announced the acquisition of Biohaven, a leader in the treatment of migraine headaches, with a total of US$ 11.6 billion. The companies expect the transaction to close by early 2023. Under the terms of the deal, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer with a 33% premium of US$ 148.50 per share in cash. Biohaven is the owner of the oral calcitonin gene-related peptide (CGRP) antagonist, Rimegepant.

18. On May 11, Zhaoke Ophthalmology and Visus Therapeutics announced an exclusive license agreement for the development and commercialization of Brimochol PF and carbachol PF in Greater China, South Korea, and select Southeast Asian territories. Brimochol PF and carbachol PF are preservative-free therapeutics designed to be long-acting, once-daily eye drops to correct for the loss of near vision associated with presbyopia.

19. On May 11, Henlius announced that it has entered into a license agreement with Eurofarma , pursuant to which, it agreed to grant Eurofarma a license to develop, manufacture and commercialize three products, rituximab injection (Hanlikang), trastuzumab injection (Hanquyou) and bevacizumab injection (Hanbeitai), in 16 Latin American countries.