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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