The failure of Phase III clinical trials targeting the popular target TIGIT monoclonal antibody has once again put tumor immunotherapy on the radar this week. The pharma news review of this week from March 28 to April 1 covers a total of 25 pieces of news in 4 sections, including  drug review, R&D, business, and listing.

NMPA

Marketing Application

1. On March 29, it was shown on the CDE official website that the new drug, Carglumic Acid Dispersible Tablets of Class 5.1, was declared for marketing and accepted. According to public information, it is a rare disease treatment product, which was initially approved overseas for hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency.

2. On March 30, it was shown on the CDE official website that Merck's Tepotinib was declared for marketing in China. Tepotinib is a c-Met inhibitor researched and developed by Merck and was first approved for marketing in Japan in March 2020. The first c-Met inhibitor approved for marketing in China was Savolitinib of Hutchison Pharmaceuticals.

Approval

3. On March 30, Yangtze River announced that its generic drug of Sugammadex Sodium Injection had been approved for marketing, becoming the first specific binding neuromuscular block antagonist approved for marketing globally. Sugammadex Sodium is a water-soluble modified γ-cyclodextrin drug that specifically binds to muscle relaxants via physical encapsulation to reverse neuromuscular blockade.

Clinical

Application

4. On March 28, it was shown on the CDE official website that the JS116 of Junshi Biosciences was first declared for clinical use in China. This is the seventh new chemical drug declared by Junshi in China. JS116 is a small molecule irreversible covalent inhibitor of KRASG12C with a novel structure, which is used for treating patients with non-small cell lung cancer (NSCLC) caused by KRASG12C mutation.

5. On March 28, it was shown on the CDE official website that the clinical application of B7H4x4-1BB double-antibody of Harbour BioMed was accepted for the treatment of solid tumors in China. HBM7008 is a First-in-Class bispecific antibody that simultaneously targets tumor antigen B7H4 and T cell co-stimulatory molecule 4-1BB. It is the only bispecific antibody targeting these two targets in the world.

6. On March 29, it was shown on the CDE official website that the GB263T for Injection of Genor Biopharma was declared for clinical use for the first time. It is the first trispecific antibody for EGFR/c-Met/c-Met in the world and is indicated for non-small cell lung cancer (NSCLC). Currently, there are seven EGFR/c-Met antibody drugs under development worldwide, and only Johnson & Johnson’s Amivantamab has been approved by the FDA for marketing.

7. On March 30, it was shown on the CDE official website that the clinical application for WJ13404 Tablet jointly invested by Junshi Biosciences and Wigen Biomedicine was accepted. WJ13404 is an effective fourth-generation EGFR inhibitor with potent inhibitory activity against third-generation EGFR-insensitive acquired EGFR variants and a high degree of selectivity for wild-type EGFR.

Approval

8. On March 29, Sino Biopharm announced that a new drug of Class 1, FHND5071, was approved by NMPA for clinical trials in the treatment of advanced solid tumors. FHND5071 is a brand new selective inhibitor of transfection rearrangement (RET) and its Investigational New Drug application has been submitted to the FDA.

9. On March 29, Hengrui Medicine announced that the Investigational New Drug application of SHR8028 Eye Drops was approved, and the clinical trials will be carried out in the near future. SHR8028 Eye Drops is a CyclASol (0.1% cyclosporin A drug product) introduced by Hengrui Medicine from Novaliq for the treatment of dry eye disease. At present, the drug is undergoing Phase 3 clinical trials in China and the United States simultaneously.

10. On March 30, it was shown on the CDE official website that the ABSK043 Capsule declared by Abbisko Therapeutics received the implied license for clinical trial approval, and the proposed indication is malignant tumor. ABSK043 is an innovative oral small molecule PD-L1 inhibitor researched and developed by Abbisko Therapeutics. The results of preclinical research will be presented at the annual meeting of the American Association for Cancer Research (AACR) in 2022.

11. On March 31, it was shown on the CDE official website that the Relmacabtagene Autoleucel Injection, a CD19CAR-T cell therapy of JW Therapeutics, was clinically approved for adult patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma after first-line systemic treatment. This application is a Phase III critical Investigational New Drug for Relmacabtagene Autoleucel as a second-line treatment for LBCL.

FDA

Marketing

12. On March 28, Novo Nordisk announced that FDA had approved its weekly subcutaneous injection of 2 mg of the GLP-1 analog, Ozempic, for the treatment of type 2 diabetes. Currently, Ozempic has been approved in the United States in doses of 0.5mg, 1.0mg, and 2.0mg for the treatment of adult type 2 diabetes.

13. On March 29, Enanta announced that  FDA had granted the company the Fast Track qualification for EDP-235, a drug taken orally once a day for the treatment of COVID-19. EDP-235, a coronavirus 3CL protease inhibitor, is currently being researched in the first phase I human research.

14. On March 30, Akebia announced that it had received a complete response letter (CRL) from FDA regarding its new drug application for Vadadustat. Vadadustat is an orally administered inhibitor of hypoxia-inducible factor prolyl-hydroxylase (HIF-PH), which is used to treat anemia due to chronic kidney disease (CKD). FDA said the current situation was not sufficient to support approval of the drug.

Clinical

15. On March 30, BioneCure announced that its Phase 1 Investigational New Drug (IND) application for BIO-106, which targets the TROP-2ADC, has been approved by the U.S. FDA. On the same day, BioneCure officially launched its clinical research in the United States.

R&D

16. On March 29, Roche updated the latest results of its Phase III clinical SKYSCRAPER-02 research. It is a global, multi-center, phase III clinical research that evaluates Tiragolumab, an anti-TIGIT monoclonal antibody, combined with Atezolizumab (Tecentriq) and chemotherapy as the first-line treatment for extensive small cell lung cancer (ES-SCLC). It failed to reach the common primary endpoint of progression-free survival (PFS) and the common primary endpoint of overall survival (OS) in the interim analysis.

17. On March 30, KeyMed announced that its phase II clinical research (CM310NP001) of the new drug CM310 for chronic sinusitis with nasal polyps had reached all the efficacy endpoints and achieved positive results. CM310 is an innovative humanized monoclonal antibody targeting the human IL-4 receptor α subunit (IL-4Rα) independently researched and developed by KeyMed.

18. On March 30, Adagio reported that the primary endpoints were met with statistical significance for all three indications in the ongoing global Phase II/III clinical trials evaluating its investigational drug adintrevimab (ADG20) as a pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19. An Emergency Use Authorization (EUA) application will be submitted for it in the near future.

19. On March 31, Alphamab announced the first interim analysis of the Phase III clinical trials of the PD-L1/CTLA4 bispecific antibody KN046 in combination with platinum-based chemotherapy for advanced unresectable or metastatic squamous NSCLC had been completed and the prespecified PFS endpoint had been reached. Alphamab will submit a New Drug Application in mid-2022.

20. On March 31, Stone Pharma announced that the first patient has been successfully enrolled in an international, multi-center, Phase I clinical trials of its antibody-drug conjugates, CS5001 (ROR1ADC), in the United States. CS5001 is one of the fastest researching and developing ADCs targeting receptor tyrosine kinase-like orphan receptor 1(ROR1) in the world, with the best potential for drugs of its kind globally.

If you want to know more about pharmaceutical products and medical product suppliers, Pharmasources would be your best choice.

Business

21. On March 28, Innovent and Eli Lilly jointly announced that they would deepen strategic cooperation and reach an agreement on the following matters: 1) Innovent obtains the exclusive right to commercialization upon approval of the import, sale, promotion, and distribution of CYRAMZA (Ramucirumab) and Retsevmo (Selpercatinib, LOXO-292) in the Chinese mainland, and 2) Innovent is granted with the preferential negotiation right to the future commercialization rights of Pirtobrutinib (LOXO-305) in the Chinese mainland.

22. On March 30, Brii Biosciences announced that its subsidiary, Brii Huachuang, had reached strategic cooperation with Sinopharm Group to jointly promote the commercialization of the long-acting COVID-19 neutralizing monoclonal antibody (mAb) therapy, the amubarvimab/romlysevimab combination (previously BRII-196/BRII-198 combination) in China. It includes stockpiling, channel distribution, regional access, and other innovative business cooperation. The combination therapy was approved for marketing in December 2021. [RH1] 

23. On March 30, Biosion signed an authorization agreement with Pyxis Oncology. According to the agreement, Pyxis Oncology will obtain the exclusive license for the global development and commercialization of BSI-060T from Biosion outside of Greater China. BSI-060T is a fully human monoclonal antibody against Siglec-15 with high affinity. The indications to be developed include non-small cell lung cancer, ovarian cancer, triple-negative breast cancer, and other solid tumors.

Listing

24. On March 31, Remegen was officially listed on the Sci-Tech Innovation Board of the Shanghai Stock Exchange. Remegen has two drugs on the market, namely Telitacicept, a new drug of "double-target" for systemic lupus erythematosus, and Disitamab Vedotin, an ADC drug that targets HER2. Seven products are currently undergoing clinical trials for more than 20 indications.

25. On March 31, Rec-Biotechnology was officially listed on the Hong Kong Stock Exchange. Rec-Biotechnology is an innovative vaccine-manufacturing company, and the core product REC603, a recombinant human papillomavirus (HPV) bivalent vaccine for the prevention of cervical cancer, is currently in Phase 3 clinical trials. A product pipeline of 12 innovative vaccines under development has been established.

 [RH1]https://www.biospace.com/article/releases/brii-bio-announces-strategic-partnership-with-sinopharm-to-advance-commercialization-of-long-acting-covid-19-neutralizing-antibody-therapy-amubarvimab-romlusevimab-combination-in-china/