Weekly Pharma News Review | PharmaSources.com (0130-0203)

On January 29, 2023, National Medical Products Administration released an announcement as follows. According to the relevant regulations of the Drug Administration Law of the People's Republic of China, and following the special approval process for drugs, National Medical Products Administration conducted the emergency drug review and approval and conditionally approved the marketing application of the first-in-class innovative drugs, Simnotrelvir Tablets/Ritonavir Tablets (co-packaged) (brand name: SIM0417) of Hainan Simcere Pharmaceutical Co., Ltd. and Renmindevir (brand name: Mindvy) of Shanghai Wangshi Biological Technology Co., Ltd.

The two drugs are small-molecule oral therapeutic drugs for infection of SARS-CoV-2, which are used for treating adult patients with mild to moderate coronavirus disease 2019 (COVID-19). Patients should take the medication strictly according to the doctor's instructions.

National Medical Products Administration requires the marketing authorization holder to continue the related researches, meet the requirements of the attached conditions by the deadline, and submit the results of subsequent studies without delay.

This article sorts out China's drug review and approval, R&D, and global business, with a statistical period of January 30 to February 3. 

Drug review and approval

Marketing

Approval

1. On January 31, the NMPA official website revealed that the zoster vaccine live of BCHT was approved for marketing, which is appropriate for adults aged 40 years and above. It had previously granted priority review. The zoster vaccine live is a high titer lyophilized vaccine, which is made by the attenuated varicella-zoster virus based on the production process of live attenuated varicella vaccine. It is a vaccine indicated for preventing elderly herpes zoster and its complication, post-herpetic neuralgia.

2. On January 31, the NMPA official website revealed that the PD-1 monoclonal antibody Camrelizumab (brand name: AiRuiKa) of Hengrui Medicine was approved for marketing for new indications, which is used in combination with Apatinib in the first-line therapy of patients with unresectable or metastatic hepatocellular carcinoma who has never received systematic treatment. It is the ninth approved indications of Camrelizumab.

Application

3. On February 1, the CDE official website revealed that Hengrui Medicine had submitted a marketing application of SHR8058 Eye Drops for the treatment of ophthalmoxerosis associated with tarsal gland dysfunction. SHR8058 Eye Drops is an innovative eye drop therapy, which Hengrui Medicine introduced from Novaliq GmbH in November 2019.

4. On February 1, the CDE official website revealed that Roche had submitted a marketing application for the first-in-class, glofitamab. It is a bispecific T-cell adaptin targeting CD20 and CD3, which was included as a drug of breakthrough therapy designation by the CDE in 2021 and will be given to adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) after second-line therapy or multi-line systematic therapy.

5. On February 2, the CDE official website revealed that CGeneTech had submitted a marketing application for the DPP-4 inhibitor Centagliptin, which is used to treat type 2 diabetes. 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.

Clinical

Approval

6. On January 30, the CDE official website revealed that the VVN461 Eye Drops of VivaVision Biotech had been approved for the clinical trial, and a Phase I trial to evaluate its safety in healthy adult subjects, as well as a middle-to-late clinical trial in patients with non-infectious anterior uveitis, will soon be conducted in China. VVN461 Eye Drops is a potent small-molecule immunomodulator highly active in inhibiting multiple cytokine pathways, thereby reducing and alleviating the inflammatory response in the eye.

7. On January 30, the CDE official website revealed that the new first-in-class, SAL0119 Tablets of Salubris, had been approved for the clinical trial. It is used in the treatment of active ankylosing spondylitis (AS) and moderate-severe active rheumatoid arthritis (RA). SAL0119 is a small-molecule oral immunosuppressant with a unique mechanism of action different from that of the JAK inhibitors and a broad-spectrum inhibitory effect on cytokines. Its preclinical research demonstrates good efficacy and safety.

8. On February 2, the CDE official website revealed that the new first-in-class, IBR854 Cell Injection of Imbioray, had been approved for the clinical trial. It is used in the treatment of patients with unresectable locally advanced or metastatic solid tumors without currently available or resistant to standard therapy. It is a universal off-the-shell CAR-raNK cell product derived from the allogeneic peripheral blood and a non-genetically modified approach to CAR-raNK cell therapy for solid tumors.

Application

9. On January 31, the CDE official website revealed that the clinical trial application of JS401 injection of Junshi Biosciences had been submitted and processed. It is for the treatment of mixed hyperlipidemia. It is the first clinical trial application of siRNA drug submitted by Junshi Biosciences, and the first potential siRNA drug of a certain target in China. JS401 is a siRNA drug developed on this platform to effectively target mixed hyperlipidemia in the long term.

Business

19. On January 31, CARsgen announced that it had entered into a clinical research collaboration agreement with Roche to evaluate the efficacy and safety of combining its humanized CLDN18.2 monoclonal antibody AB011 with Roche's Atezolizumab and standard treatment and chemotherapy in treating patients with gastric cancer or gastroesophageal junction cancer. Under the agreement, Roche will be responsible for the operation, management, and advancement of the clinical trial, and CARsgen and Roche will share the costs of the AB011 dosing group in the clinical trial.

20. On February 2, Zhimeng Biopharma announced that it had entered into an exclusive global license agreement with GSK for CB06. Under the agreement, Zhimeng Biopharma will allow GSK to develop, produce, and commercialize CB06 after the phase I clinical research is completed successfully. When that day comes, CB06 can be used in combination therapy or sequential treatment with bepirovirsen. CB06 is a small-molecule oral TLR8 agonist independently developed by Zhimeng Biopharma.