The news review of this week is from April 24 to 29, covering a total of 20 pieces of information in 3 sections, i.e., drug review, R&D, and business.

Approval

NMPA

Marketing

Application

1. On April 24, CDE's official website revealed that Jingxin Pharmaceutical submitted the application for a first-in-class drug, EVT201 capsule, for insomnia. As for the partial positive allosteric modulator for the receptor of EVT201 GABAA (Gamma-aminobutyric acid A), Jingxin Pharmaceutical collaborated with Evotec of Germany in 2010 and acquired the exclusive patent license and development right of it in China.

2. On April 24, CDE accepted the marketing application of Qilu Pharmaceutical's dolutegravir sodium. It is the first time for a generic drug of this type to be declared for marketing in China. Dolutegravir was an anti-AIDS drug developed by GSK/ViiV, which is categorized as an integrase inhibitor. In 2015, dolutegravir tablets were approved for marketing in China.

3. On April 24, CDE's official website revealed that Bayer's marketing application for new indications of darolutamide tablets for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) was accepted. As an oral androgen receptor inhibitor (ARi), Darolutamide tablets are approved for marketing in China in February 2021 for the treatment of adult patients with nmCRPC.

4. On April 25, CDE revealed that a marketing application for new indications of nimotuzumab injection, submitted by Biotech Pharma, was accepted. Nimotuzumab was an anti-EGFR humanized monoclonal antibody, which had been approved for the treatment of nasopharyngeal carcinoma in China earlier.

5. On April 27, Suzhou Zelgen Biopharmaceuticals Co., Ltd. announced the submission of the marketing application for its recombinant protein new drug, recombinant human thrombin for external use. Independently developed by Zelgen, recombinant human thrombin for external use is a highly specific human serine protease. The Phase III trial of this drug has reached the presupposed primary endpoint.

6. On April 28, the CDE official website revealed that Qilu Pharmaceutical's Aflibercept Intravitreous Injection was accepted for a marketing application. It was the first biosimilar drug applied in this variety in China. Aflibercept, an anti-VEGF drug jointly developed by Regeneron and Bayer, was approved for marketing in China in February 2018.

Clinical

Application

7. On April 26, CDE revealed that a first-in-class drug of Henlius, HLX53 was declared for clinical use, which is the initial declaration of this drug for clinical use in China. HLX53 is an anti-TIGIT monoclonal antibody independently developed by Henlius. Currently, there were 17 TIGIT antibody projects in the clinical stage in China, including 11 monoclonal antibodies and 6 bispecific antibodies.

Approval

8. On April 26, the CDE official website revealed that allogeneic endothelial progenitor cells (EPCs) injection (ALF201) declared by Allife Medicine had acquired an implied license for clinical trials. It is intended to be developed for the treatment of large-artery atherosclerosis acute ischemic stroke. ALF201 was an endothelial progenitor cell injection prepared by Allife Medicine based on iPSC directional differentiation endothelial progenitor cell stock solution.

9. On April 28, a new indication of Eli Lilly's GLP-1R/GIPR double agonist, Tirzpatide, was approved for a clinical trial in China. It is used for single intervention drug treatment of adult patients with moderate to severe obstructive sleep apnea (OSA) and body mass index (BMI) ≥ 30kg/m2.

Priority review

10. On April 24, CDE intended to include the marketing application of a HER2-directed ADC drug Enhertu of Daiichi Sankyo/AstraZeneca in the updated publicity list of priority review. Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more anti-HER2 based regimens.[RH1] 

Breakthrough therapy

11. On April 26, CDE revealed that it planned to include Allist's Furmonertinib Mesilate Tablets in breakthrough therapy for the treatment of patients with positive EGFR exon 20 insertion mutation, or with locally advanced or metastatic non-small cell lung cancer (NSCLC) during or after platinum-containing chemotherapy.

FDA

Marketing

12. On April 25, AstraZeneca announced that the Biologics License Application (BLA) for the indication of unresectable hepatocellular carcinoma was accepted by FDA. The cancer was under the first-line treatment by the combination between CTLA-4 monoclonal antibody, tremelimumab, and PD-L1 monoclonal antibody, durvalumab (Imfinzi). AstraZeneca had used the priority review voucher for this application, and the PDUFA date was in Q4 of 2022.

Breakthrough therapy

13. On April 27, AstraZeneca and Daiichi Sankyo jointly announced that Enhertu, an HER-2 ADC drug, had acquired Breakthrough Therapy Designation (BTD) from FDA for the treatment of adult patients with unresectable or metastatic HER2-low (IHC1+or IHC2 +/ISH-negative) breast cancer who have received at least one prior system therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Fast Track

14. On April 26, OncoC4 announced that FDA had granted ONC-392 Fast Track as a monotherapy[RH2]  to treat patients with metastatic non-small cell lung cancer (NSCLC) who had progressed after receiving anti-PD-1/L1 therapy. ONC-392 is a new generation of anti-CTLA-4 monoclonal antibody being developed by OncoC4 and AcroImmune Group, which was currently in Phase I clinical research globally.

R&D

Launching the clinical trials

15. On April 25, Innolake Biopharm announced the first patient dosing of ILB-2109 in the Phase 1a clinical trials for the advanced solid tumors. Based on preclinical research, as a novel A2aR selective antagonist, ILB-2109 was efficient and secure in tumor resistance.

16. On April 27, VITRAC, a U.S. subsidiary of JS InnoPharm, announced the launch of Phase 1/2 clinical trials to evaluate the safety and efficacy of Aurora A kinase inhibitor VIC-1911 combined with sirolimus and post-transplant cyclophosphamide (PTCy) in the prevention of graft-versus-host disease (GVHD) in myeloablative allogeneic hematopoietic stem cell transplantation.

17. On April 28, the drug clinical trial registration and information publicity platform of CDE revealed that Novartis's Zolgensma was put into clinical practice in China for the first time. This is a Phase III clinical trial, which is categorized as the Chinese part of the global Phase III clinical STEER research (NCT05089656), targeting patients ranging from 2 to 18 years old with type 2 spinal muscular atrophy (SMA). Zolgensma is a gene therapy for SMA and is currently the most expensive drug in the world. [RH3] 

Clinical data release

18. On April 27, BeiGene announced that RATIONALE306, a global Phase III clinical trial of PD-1 monoclonal antibody Tislelizumab (brand name: Baizean) in the first-line treatment of esophageal squamous cell carcinoma (ESCC), had acquired promising results. According to the pre-set interim analysis by the Independent Data Monitoring Committee (IDMC), it had reached the primary endpoint of overall survival (OS).

Business

19. On April 25, Arrowhead announced that it had established a joint venture company, Visirna, with Vivo Capital. Arrowhead had also signed a licensing agreement with Visirna. On the basis of the agreement, the joint venture company acquired the exclusive right to develop and commercialize 4 RNAi drugs under development by Arrowhead in Greater China for the treatment of cardiac metabolic diseases.

20. On April 26, Xbiome announced that it had acquired the clinical-stage M201 from Assembly Biosciences. The M201 program is designed for patients with mild to moderate ulcerative colitis. It is comprised of a rationally designed consortium of commensal bacteria that were selected based on [RH4] the ulcerative colitis-relevant biological mechanism and cellular modulation mechanism.