The first therapeutic effect data of VV116, a small-molecule oral drug for COVID-19 of Junshi Biosciences and Vigonvita, was released this week, captivating the industry.
The news review of this week is from May 16 to 20, covering 17 pieces of news in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA
Marketing Approval
1. On May 19, the review result of ACEA Pharma's Avitinib is finally available. The company failed to obtain marketing approval from NMPA for Avitinib this time. Avitinib is the first third-generation EGFR-TKI (EGFR tyrosine kinase inhibitor) to be declared for marketing in China, and the marketing application was submitted in June 2018. In addition, Sorrento has completed the acquisition of ACEA Pharma for a potential worth up to US$ 488 million. [RH2]
2. On May 19, NMPA issued an announcement approving Bayer's Vericiguat for the treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). Vericiguat, the first-in-class soluble Guanylate Cyclase (sGC) agonist, was co-developed and promoted by Bayer and MSD.
Clinical
Approval
3. On May 16, CDE's official website revealed that Immune-Onc Therapeutics' IO-108 is clinically approved to treat advanced solid tumors. IO-108 is a novel inhibiting antibody targeting Leukocyte Immunoglobulin-like Receptor B2 (LILRB2, also known as ILT4), an immune checkpoint in myeloid cells. It is also the first LILRB2 antibody to receive clinical approval in China.
4. On May 17, Simcere Pharmaceutical announced the clinical approval of its 3CL protease inhibitor SIM0417.[RH3] It is proposed for post-exposure prophylaxis for close contacts of individuals who test positive for SARS-CoV-2. The Phase II/III clinical trials of SIM0417 were initiated on May 12. It will be combined with ritonavir for the treatment of adult patients with mild to moderate COVID-19.
5. On May 19, CDE's official website announced that XZB-0004 capsules filed by Xuanzhu Biotechnology were clinically approved. The proposed indications are hematological malignant tumors and advanced solid tumors. XZB-0004 is an AXL-targeted inhibitor. In September 2021, Xuanzhu Biotechnology entered into a collaboration with SignalChem to introduce the exclusive development and commercialization rights of the drug in Greater China for over US$ 220 million.
R&D
Launching the clinical trials
6. On May 16, MingMed Biotechnology announced that the Phase II clinical trials of its investigational product, QA102, a potential first-in-class small-molecule ophthalmic drug for the treatment of Dry Age-related Macular Degeneration (Dry AMD), have been launched in the United States and the subject dosing is about to start.
Clinical data release
7. On May 16, Bristol Myers Squibb (BMS) announced that the Checkmate-901 study failed to meet the primary endpoint in the final analysis of overall survival (OS) in individuals whose tumor cells express PD-L ≥1%. The study is a Phase III clinical trial of PD-1 monoclonal antibody Opdivo combined with CTLA-4 monoclonal antibody Yervoy for the first-line treatment of unresectable or metastatic urothelial carcinoma. As of press time, the data has not yet been released to the public.
8. On May 16, Boehringer Ingelheim announced Phase II data for BI 1015550[RH4] , a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine (NEJM). The promising 12-week data showed a reduction in the rate of lung function decline in patients with idiopathic pulmonary fibrosis (IPF).
9. On May 17, the first therapeutic effect data for VV116 of Junshi Biosciences/ Vigonvita was published in the Emerging Microbes & Infections. The study evaluated the impact of VV116 on the time required to turn from positive to negative nucleic acid in patients with non-severe Omicron infection. The results showed that VV116 is a safe and effective oral antiviral drug with improved performance during the early onset for patients with Omicron infection.
10. On May 17, CStone announced the results[RH5] of the final Progression-free Survival (PFS) analysis of a registrational study (GEMSTONE-301 study) of the anti-PD-L1 monoclonal antibody Sugemalimab in patients with Stage III NSCLC. Sugemalimab further improved PFS as assessed by blinded independent central review (BICR) wit...
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