Weekly Pharma News Review | PharmaSources.com (1008-1014)

This week, in terms of drug review and approval, the most exciting thing for the industry is that a first-in-class drug named Dorzagliatin Tablets, which is independently researched and developed by Hua Medicine was approved for marketing, becoming the first approved new drug for GKA diabetes in the world. In terms of R&D, pivotal progress has been made in several important clinical researches, and the PFS superiority has been achieved in the global, Phase III, head-to-head research of Zanubrutinib in BeiGene. In terms of business, it's a bit unremarkable. Immune-Onc Therapeutics and BeiGene have reached a strategic cooperation agreement to jointly research the concomitant medication of myeloid checkpoint inhibitors IO-108, IO-202, and Tislelizumab.

The news review of this week is from October 8 to 14, covering a total of 25 pieces of information in 3 sections, i.e. drug review and approval, R&D, and business.

Drug Review

NMPA – Marketing

[Approval]

1. On October 8, the NMPA official website revealed that a first-in-class drug, Dorzagliatin Tablets, developed by Hua Medicine had been approved for marketing to treat type II diabetes. Dorzagliatin is a first-in-class glucokinase initiator (GKA), which can be used as a  monotherapy or in combination with a currently approved diabetes drug.

2. On October 9, the NMPA official website revealed that the new indication for the PD-1 inhibitor Pembrolizumab Injection of MSD was approved. It is the 9th indication approved for Pembrolizumab in China and is intended for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received Sorafenib or Oxaliplatin.

NMPA – Marketing

[Application]

3. On October 8, the CDE official website revealed that the marketing application for the second indication of Dexmedetomidine Hydrochloride Nasal Spray, a class-2.2 new drug of Hengrui Medicine, had been processed for the treatment of preoperative sedation for children (such as general anesthesia for children). Dexmedetomidine Hydrochloride Nasal Spray is an improved new drug. Compared with injection, nasal spray has the advantages of high bioavailability and convenient drug administration, especially suitable for children.

4. On October 9, the CDE official website revealed that a marketing application for new indications of the first-in-class, Pyrotinib Maleate Tablets, developed by Hengrui Medicine, had been processed for the treatment of HER-2 positive relapsed/metastatic breast cancer with the combination of Trastuzumab and Docetaxel. Pyrotinib is an oral HER1/HER2/HER4 tyrosine kinase inhibitor and has been approved for two indications, both of which are breast cancer.

5. On October 13, the CDE official website revealed that the marketing application of the new indications of Stone Pharma’s Pralsetinib had been processed, intended for the first-line treatment of locally advanced or metastatic RET fusion-positive NSCLC. Pralsetinib, an oral, once daily, potent, and highly selective RET inhibitor, was approved in March 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received platinum-containing chemotherapy for RET fusion-positive.

NMPA – Clinical Trials

[Approval]

6. On October 10, the CDE official website revealed that the CL-197 capsule of Genuine Biotech had been approved for clinical trials, intended for the treatment of adult patients infected with HIV-1. CL-197 is a potential long-acting novel oral HIV candidate and belongs to the purine nucleoside reverse transcriptase inhibitor (NRTI). CL-197 capsule is expected to be taken once a week.

7. On October 12, the CDE official website revealed that the Nolasiban Dispersible Tablet of ObsEva had been approved for clinical trials, and it was planned to be developed to improve the clinical pregnancy rate of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) patients with abnormal endometrial contractions before embryo transfer. Nolasiban is a potential first-in-class oral oxytocin receptor antagonist, and Yuyuan Life has the right to develop and commercialize it in China.

[Application]

8. On October 9, the CDE official website revealed that BGM0504 of Bright Gene had been declared for clinical trials in China. As a dual agonist of GLP-1 and GIP receptors, BGM0504 can produce biological effects such as blood glucose control, weight loss, and treatment of NASH. This is the third dual GIPR/GLP-1R agonist declared for clinical trials. At present, only one dual GIPR/GLP-1R agonist is on the market in the world.

9. On October 9, the CDE official website revealed that SAL008(JK08) of Salubris had been declared for clinical trials in China for the treatment of advanced solid tumors. SAL008 is a fusion protein of IL-15/IL-15Rα complex and anti-CTLA-4 antibody, which was independently researched and developed by Salubris.

10. On October 10, the CDE official website revealed that Simcere Pharmaceutical's SIM0237 injection was applied for clinical trials in China. SIM0237 is a PD-L1/IL15v bifunctional fusion protein, and it is a potential best-in-class anticancer drug with a wide therapeutic window through mutation and attenuation. It was found in the preclinical research that the effect of this drug is significantly better than that of PD-L1 single-drug and IL-15 single-drug in a mouse tumor model.

11. On October 10, the CDE official website revealed that Simcere Pharmaceutical's SIM0348 injection was applied for clinical trials in China. SIM0348 is a kind of TIGIT/PVRIG bispecific antibody, which is the first bispecific antibody declared by Simcere Pharmaceutical. Preclinical research showed that the in vitro activity and drug effect of SIM0348 is significantly better than that of Roche's TIGIT monoclonal antibody Tiragolumab, achieving the anti-tumor effect of 1+1 > 2, and the combination with PD-L1 monoclonal antibody Tecentriq may get a synergistic effect.

12. On October 10, the CDE official website revealed that the EMB-09 injection of EpimAb Biotherapeutics was applied for clinical trials in China for the treatment of advanced solid tumors. EMB-09 is a bispecific antibody independently researched and developed by EpimAb Biotherapeutics based on Fabs-In-Tandem technology, which can block the interaction between PD-1 and PD-L1 and conditionally activate the OX40 signaling pathway through PD-L1-mediated cross-linking reaction.

FDA - Marketing

[Approval]

13. On October 10, scPharmaceuticals announced that Furosemide Subcutaneous Injection (Furoscix) was approved by the FDA for marketing for the treatment of congestion caused by fluid overload in adult patients with class II/III chronic heart failure. Furosemide Subcutaneous Injection has become the world's first hypodermic circulation diuretic, which can be used by patients at home on their own.

14. On October 12, the FDA announced that it had amended the Emergency Use Authorization (EUAs) of the Moderna COVID-19 Vaccine, Bivalent, and Pfizer-BioNTech's bivalent COVID-19 vaccine to authorize their use as a single booster dose in younger populations at least two months following completion of primary or booster immunization. Among them, the bivalent COVID-19 mRNA vaccine of Moderna (mRNA-1273.222) was authorized for a booster dose in children down to 6 years of age. Pfizer-BioNTech's COVID-19 vaccine, bivalent is licensed for booster vaccination in children down to 5 years of age.

[Orphan Drug Designation]

15. On October 12, Remegen announced that Telitacicept (R&D code: RC18) had obtained the FDA's Orphan Drug Designation for the treatment of myasthenia gravis (MG). Previously, the domestic Phase II clinical research of Telitacicept in the treatment of systemic myasthenia gravis (gMG) has been completed with positive results.

[Priority Review]

16. On October 11, Gilead Sciences announced that a supplemental Biologics License Application (sBLA) for Trodelvy to treat patients with unresectable locally advanced HR+/HER2- metastatic breast cancer, regardless of HER2 status, had been processed by the FDA and granted priority review status. The date of PDUFA is February 2023.

R&D

Clinical trials Status

17. On October 10, Harbour Biomed announced its decision to terminate its Phase III trial of tanfanercept in China based on the observed trend of insufficient efficacy, as recommended by the Independent Data Monitoring Committee (IDMC), and not to enroll new subjects, but to continue to follow up existing subjects according to the clinical trial protocol. Tanfanercept is a TNF receptor-1 fragment drug developed by HanAll for patients with moderate and severe dry eye disease.

18. On October 10, Sciwind Biosciences announced that a Phase I clinical trial of XW014 for the treatment of obesity and type II diabetes was initiated in the United States, and the administration of the first subject was completed on September 28. As an oral small-molecule drug, XW014 is a novel oral small-molecule GLP-1 receptor agonist.

19. On October 12, Merck, Germany, launched an international multi-center (including China) Phase III clinical trial of xevinapant oral solution for subjects with locally advanced squamous cell carcinoma of the head and neck, according to the drug clinical trial registration and information publicity platform of CDE. Xevinapant is a highly potent oral antagonist of a potential first-in-class inhibitor of apoptotic proteins (IAP).

Clinical data release

20. On October 10, Wantai BioPharm announced that the COVID-19 vaccine, a nasal spray influenza virus vector developed in cooperation with Xiamen University and Hong Kong University, had completed the interim master data analysis of phase III clinical trial and obtained pivotal data. The results showed that the absolute protective efficacy of the nasal spray COVID-19 vaccine within three months was 55% for the population without immunization history. For the population with an immunization history, the absolute protective efficacy within 6 months after the nasal spray of the COVID-19 vaccine to enhance immunity was 82%; The protective efficacy of the population over 60 years old is not weaker than that of people aged 18-59.

21. On October 11, Juventas and the Institute of Hematology, Chinese Academy of Medical Sciences jointly announced that the CAR-T product Hejilensai injection (proposed) targeting CD19 has reached the primary endpoint in the pivotal clinical research of treating adult patients with relapsed or refractory acute B-lymphoblastic leukemia (r/r B-ALL).

22. On October 12, CGeneTech announced that the phase III clinical trial of Cetagliptin for the treatment of type II diabetes has completed pivotal clinical research. The results showed that the dose of 50mg can reach the preset endpoint of the trial. Cetagliptin is a first-in-class which is independently researched and developed by CGeneTech. As a new oral DPP-4 inhibitor, it has the advantages of high selectivity and strong inhibition.

23. On October 12, Albireo Pharma announced positive topline results from its Phase III ASSERT research evaluating the safety and efficacy of odevixibat (Bylvay) in Alagille syndrome patients. Odevixibat is a potent, non-systemic inhibitor of ileal bile acid transport (IBATi), with minimal systemic exposure, that only acts locally in the intestine.

24. On October 12, BeiGene announced that Zanubrutinib had achieved superior Progression-Free Survival (PFS) versus Ibrutinib in a final analysis of the global phase III ALPINE trial. Zanubrutinib became a BTK inhibitor with PFS superiority over Ibrutinib "head-to-head" in chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL).

Business

25. On October 10, Immune-Onc Therapeutics announced that it had reached a clinical trial cooperation and supply agreement with BeiGene. As a part of the clinical development project in China, the aim is to evaluate the efficacy of the first-in-class myeloid checkpoint inhibitors IO-108 and IO-202 in combination with BeiGene PD-1 inhibitor Tislelizumab.