The new review this week is from January 4th to 7th, covering a total of 18 pieces of information in 4 sections, i.e. review, policy, listing, and others. 

Review 

NMPA 

Listing 

1. On January 4, the official website of CDE announced that Salubris submitted the listing application for Enarodustat tablets and received acceptance, which is a new drug with the indication of renal anemia. In December 2019, Salubris introduced Enarodustat, an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) from Japan Tobacco, which is expected to be the second drug of its kind to be listed following Roxadustat. 

2. On January 5, the official website of NMPA announced that the second indication of Remegen's Disitamab Vedotin was approved for listing. It is targeted at patients with locally advanced or metastatic urothelial carcinoma who have received prior systemic chemotherapy and HER2 expression of 2+ or 3+ on immunohistochemistry. As the first Chinese-made ADC approved for listing, Disitamab Vedotin obtained its first approval in June 2021. 

3. On January 5, the official website of NMPA announced that the listing application review status of CSPC's Class 2.2 new drug, Mitoxantrone Hydrochloride Liposome Injection, has been updated to "under review" and it is expected to be approved in the near future. The drug is aimed at patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who had been treated with first-line standard therapy in the past. 

4. On January 5, the latest NMPA approval revealed the listing of the 6th indication for BeiGene PD-1 monoclonal antibody, Tislelizumab, was approved. It is for the treatment of second- or third-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression after receiving platinum-based chemotherapy. This sBLA relies on the results of the interim analysis of RATIONALE303, which clinically met the OS primary endpoint. 

5. On January 5, the official website of CDE announced that the listing application of SHR8008 capsule, a Class 1 new drug imported by Hengrui Medicine, was accepted. It is for the treatment of acute vulvovaginal candida mycoderma bacteria disease. SHR8008 is a novel oral azole antifungal drug that inhibits the fungal CYP51 enzyme with a high degree of specificity. Hengrui acquired the rights to this drug in Greater China from Mycovia in June 2019. 

6. On January 5, NMPA issued approval for a new indication of Eli Lilly's CDK4/6 inhibitor, Abemaciclib. The combined endocrinotherapy (tamoxifen or aromatizing enzyme inhibitor) is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, and early-stage breast cancer with a high risk of recurrence and Ki-67≥20%. 

7. On January 5, the official website of NMPA announced that CGeneTech's teriflunomide tablets were officially approved in China for the treatment of relapsing multiple sclerosis. Teriflunomide is an immunomodulator with an anti-inflammatory effect. The R&D of the original drug was conducted by Sanofi and it has been listed in China. 

8. On January 5, the official website of NMPA announced the approval of the second indication of Pfizer's introduction of isavuconazonium sulfate, Cresemba for the treatment of invasive aspergillosis in adults. Developed jointly by Astellas Pharma Inc. and Basilea Pharmaceutica Ltd., Cresemba is a triazole antifungal for intravenous and oral use. In December 2021, it was approved for listing in China, becoming the first oral antifungal drug approved for the treatment of invasive mucormycosis for adults in China. 

9. On January 6, the official website of NMPA announced that the status of the listing application of Romiplostim for Injection by Kyowa Hakko Kirin was changed to "under review" and it is expected to be approved in the near future. The drug is targeted at the treatment of primary immune thrombocytopenia (ITP). Romiplostim is a second-generation oral TPO-R agonist drug.

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Clinic 

10. On January 4, CStone Pharmaceuticals announced the approval of a clinical trial application for Larotrectinib in ROS1-positive advanced non-small cell lung cancer (NSCLC), which is the first pivotal study of Larotrectinib in this regard. Larotrectinib, developed by Pfizer, is a third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) with central nervous system penetration. 

11. On January 5, Akeso, Inc. announced that Candonilimab (PD-1/CTLA-4 double-antibody) in combination with Ivonescimab (PD-1/VEGF double-antibody) obtained CDE approval to conduct a Phase Ib/II clinical research with or without chemotherapy for the treatment of advanced non-small-cell lung cancer (NSCLC). This clinical research is the first double-antibody + double-antibody combination therapy in the world that has entered clinical research. 

12. On January 5, Laekna released the approval of a Phase 1/2 dose-escalation and efficacy/safety study of a three-drug combination of afuresertib + sintilimab + chemotherapy, which is targeted to treat patients with specific solid tumors resistant to PD-1/PD-L1. 

13. On January 6, the official website of CDE announced that Nankai University submitted the clinical trial application of Class 1 new drug CP0119 tablets and it was accepted. Information publicly available says that CP0119 is an intestinal motility accelerant developed by a team from Nankai University. This accelerant is characterized by a new target and it is developed for the treatment of colon slow transmission diseases. 

Breakthrough therapy 

14. On January 4, the official website of CDE announced that PI3Kδ inhibitor, SHC014748M Capsules, of Sanhome Pharmaceutical Co., Ltd., is proposed to be included in breakthrough therapies for the treatment of relapsed or refractory follicular lymphoma (FL). SHC014748M capsule is a Class 1 new drug independently developed by Nanjing Sanhome Pharmaceutical Co., Ltd. with independent intellectual property rights, and is currently in Phase 2 clinical stage.

FDA 

15. On January 4, Tianjin Chase Sun Pharmaceutical Co., Ltd. declared that the company's investigational new drug KB was granted the fast-track status by the U.S. FDA for the treatment of sepsis. KB, with dual targets of LPS and CpGDNA, is a bacterial pathogen-associated molecular antagonist. 

Policy 

16. On January 6, Joint Purchasing Office issued a notice that the purchasing amount of each medical institution for the selected insulin products of special joint purchasing has been confirmed. The corresponding agreed purchasing amount can be viewed by the provincial medical insurance departments and the selected enterprises on the official website. The selected results for the joint purchasing of insulin will be implemented in May 2022 in all regions. 

Listing 

17. On January 7, Asieris was officially listed on SSE Star Market. Asieris is a company that is about to enter the commercialization stage, specializing in the field of genitourinary tumors and other major diseases. According to the prospectus, the R&D of 9 products is currently in process, of which 3 studies of 2 innovative products are in Phase 3 or pivotal clinical trials. 

Others 

18. On January 4, Junshi announced to terminate its PD-1 promotion collaboration with AstraZeneca. On February 28, 2021, Junshi awarded AstraZeneca the exclusive rights to promote Toripalimab in the urologic oncology indication and exclusive promotion vouchers for all approved indications in non-core city areas. 

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.