Weekly Pharma News Review | PharmaSources.com (March 14 to 18)

One of the most exciting news of this week was the marketing approval of duvelisib capsules, a dual PI3K inhibitor introduced by CSPC Pharmaceutical Group Co., Ltd. Meanwhile, the oral nucleoside anti-SARS-CoV2 drug from Junshi Biosciences has initiated phase-three clinical research and the enrollment and dosing of the first patient have been completed. The pharma news review of this week covers a total of 24 pieces of news in 3 sections, i.e. review approval, R&D, and business. 

Review Approval

NMPA 

Marketing 

1. On March 14, the CDE official website revealed that InnoCare Pharma’s Supplemental New Drug Application (sNDA) of the BTK inhibitor Orelabrutinib for new indications was accepted for marketing, intending to treat patients with relapsed/refractory Waldenström’s macroglobulinaemia. In December 2020, Orelabrutinib was approved in China for treating relapsed/refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), and for two indications of relapsed/refractory Mantle Cell Lymphoma (MCL). 

2. On March 15, the CDE official website revealed that the marketing application for the new indication of PD-1 monoclonal antibody (mAB) Zimberelimab Injection of Gloria Pharmaceuticals and WuXi Biologics was accepted, and the indication is likely to be recurrent or metastatic cervical cancer. Zimberelimab is a whole-human PD-1 mAB with an independent intellectual property right, which was commissioned by Gloria Pharmaceuticals to be developed by WuXi Biologics. It is also the first PD-1 mAB declared for cervical cancer indication in China.

3. On March 16, Bayer announced that the rivaroxaban tablet (brand name: rivaroxaban) was approved in China for the treatment of the new indication of Venous Thromboembolism (VTE) and prevention of VTE recurrence after at least 5 days of initial non-oral anticoagulant therapy in children and adolescents under 18 years of age and weighing 30kg to 50kg and above. The drug is currently the only anticoagulant available in China for the treatment of VTE in children and the prevention of its recurrence. 

4. On March 18, according to the latest announcement on the NMPA official website, CSPC’s duvelisib capsule has been approved for the treatment of relapsed or refractory Follicular Lymphoma (FL) after at least two previous systemic treatments. According to public information, duvelisib is a dual inhibitor of PI3K-δ and PI3K-γ, and CSPC has an exclusive license for the development and commercialization of this product in Greater China. 

5. On March 18, according to the latest announcement on the NMPA official website, Betta Pharmaceuticals’ ensartinib has been approved for marketing for a new indication in China. The press release issued earlier by Betta Pharmaceuticals indicated that the new indication for the approval is the first-line treatment of non-small cell lung cancer (NSCLC). 

6. On March 18, NMPA announced on its website that ramucirumab injection, a VEGFR-2 monoclonal antibody innovative drug declared by Eli Lilly, has been approved for marketing in China. According to an earlier press release issued by Eli Lilly, the indication declared this time is presumed to be the second-line treatment for advanced gastric cancer. 

Clinical Trials 

7. On March 14, the CDE official website revealed that AstraZeneca’s PD-1/TIGIT bispecific antibody AZD2936 was firstly declared for clinical trials in China. AZD2936’s TIGIT antibody sequence is from Compugen’s COM902. Currently, AZD2936 is in Phase I/II development globally. 

8. On March 14, Konruns Pharmaceutical announced to withdraw the application of the Investigational New Drug for teriparatide injection due to the need to further improve the application materials. Teriparatide is a recombinant human parathyroid hormone (PTH) analog (rhPTH[1-34]), developed by Pfenex and approved by the FDA, which is a generic drug of teriparatide injection from the original R&D manufacturer, Eli Lilly. 

9. On March 16, CDE publicly announced on its official website that Novartis’s application for the Investigational New Drug of lifitegrast eye drops has been granted implied permission. The eye drop is intended for treating signs and symptoms of dry eyes. According to public information, the drug is the first prescription drug approved to treat the signs and symptoms of dry eye disease by inhibiting the inflammation caused by the disease, and treatment against inflammation is considered to be the key to dry eye treatment. 

10. On March 16, the CDE official website revealed that implied permission for clinical trials of JMKX000623 with the indication of ache was granted to Shanghai Jiyu Medical Technology Co., Ltd, a wholly-owned subsidiary of Jimincare. JMKX000623 is a highly selective ion channel blocker independently developed by Shanghai Jiyu. 

11. On March 17, the CDE official website revealed that InnoCare Pharma’s Tafasitamab for Injection made its first clinical declaration in China. This is the second CD19 monoclonal antibody declared in China. Previously, only one similar drug in China, Inebilizumab from Hansoh Pharmaceutical Group/VielaBio, was under research, which has just been approved for marketing. 

12. On March 17, the CDE official website revealed that the CTA101 UCAR-T cell injection developed by Bioheng was approved for clinical trials, with the proposed indication of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). 

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Breakthrough Therapy 

13. On March 14, the CDE official website revealed that Novartis’ LNP023 capsule is proposed for inclusion in the breakthrough therapy program for C3 glomerulopathy (C3G). LNP023 is a first-in-class, orally targeted B-factor inhibitor, a key driver of complement-dependence renal diseases (CDRDs). Currently, the highest phase that has been reached for LNP023 in China is Phase III clinical development.

FDA 

14. On March 14, AstraZeneca announced that the FDA issued a complete response letter (CRL) to the Supplemental Biologics License Application (sBLA) for benralizumab (brand name: Fasenra), concluding that the new indication for benralizumab in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) requires additional clinical data before  being approved. 

15. On March 14, SinoMab BioScience announced the Investigational New Drug application (IND), for the treatment of patients with asthma for the Company’s First-in-Class therapeutic product SM17 (humanized anti-IL-17RB monoclonal antibody for injection), was approved by the FDA. The company will initiate the first human clinical research of the drug in the US as early as the first quarter of this year. 

16. On March 16, Adagene announced FDA clearance for Phase 1b/2 trial of its anti-CTLA-4 monoclonal antibody ADG126 in combination therapy with anti-PD-1 antibody pembrolizumab. This global trial will evaluate patients with advanced/metastatic solid tumors at multiple clinical centers in the US and the Asia-Pacific region. 

17. On March 16, Cstone Pharmaceuticals’ partner Servier announced that the FDA has accepted a Supplemental New Drug Application (sNDA) for ivosidenib as a potential treatment option for previously untreated patients with primary IDH1 mutant Acute Myeloid Leukemia (AML). 

R&D 

18. On March 14, Henlius announced that it has completed its Phase 1 clinical research for HLX71, demonstrating a favorable safety and tolerability profile in the Phase 1 clinical study conducted in healthy adult subjects. HLX71 is a recombinant human angiotensin-converting enzyme 2 (hACE2) fusion protein with IgG1Fc at the C-terminus developed by Henlius and is intended for treating COVID-19. 

19. On March 14, Bristol-Myers Squibb and Nektar announced the first analysis of the Phase 3 PIVOT IO-001 study. The study evaluated the efficacy of biased IL-2bempegaldesleukin in combination with PD-1 monoclonal antibody nabolutumab (Opdivo) in the first-line treatment for unresectable or metastatic melanoma, and the analysis results of the independent Data Monitoring Committee (DMC) showed that the two-drug treatment group failed to show clinical benefit compared to the single-drug group. 

20. On March 14, Sanofi announced the Phase 2 clinical AMEERA-3 study for Amcenestrant in patients with locally advanced or metastatic ER+/HER2-breast cancer that has progressed after hormone therapy failed to meet the primary endpoint of PFS. Amcenestrant is an oral SERD that binds to the estrogen receptor (ER) in breast cancer cells, inhibiting its normal function and triggering degradation. 

21. On March 15, MSD announced that the Phase III clinical KEYLYNK-010 study of the PD-1 monoclonal antibody pembrolizumab in combination with Lynparza, a PARP inhibitor, for the treatment of patients with Metastatic Castration-resistant Prostate Cancer (mCRPC) who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide did not demonstrate a benefit in overall survival (OS) and the radiographic progression free survival (rPFS) (dual primary endpoints of the study) in an interim analysis, but increased the incidence of grade 3-5 adverse events. 

22. On March 16, Junshi Biosciences announced that VV116 tablet, an oral nucleoside anti-SARS-CoV2 drug developed by its subsidiary Shanghai DreamTop Biotech Co., Ltd. in collaboration with Suzhou Vigonvita, has initiated an international, multicenter, randomized, double-blind, controlled Phase III clinical research. It aims to evaluate the efficacy and safety of VV116 versus standard therapy in subjects with moderate-to-severe symptoms of COVID-19, and the enrollment and dosing of the first patient have been completed. 

23. On March 17, according to the drug clinical trial registration and information publicity platform of CDE, Everest Medicines has initiated a Phase 3 clinical trial of Nefecon in China for treating patients with primary IgA nephropathy. According to public information, Nefecon is an orally targeted budesonide extended-release capsule introduced by Everest Medicines, which was approved in the US at the end of last year. It is the first therapeutic drug approved by the FDA to reduce proteinuria in patients with IgA nephropathy. In China, Nefecon was previously included in the breakthrough therapy category. 

Business 

24. On March 18, Canwell announced the completion of Series A financing of nearly RMB 200 million. Led by Lapam Capital, the funds raised this time will be used to accelerate the ongoing clinical trials of CAN1012, a TLR7 agonist, as well as product development for multiple innovative pipelines. CAN1012 is a small-molecule agonist self-developed by Canwell for the Class 1 new drug Toll-like receptor (TLR7) .