Weekly Pharma News Review | PharmaSources.com (0815-0819)

This week, Alphamab Oncology’s JSKN003 injection became the first Chinese bispecific antibody ADC declared for clinical use. The news review of this week is from August 15 to 19, covering a total of 24 pieces of information on drug review, R&D, and business.

Drug Review

NMPA – Marketing

[Approval]

1. On August 15, Roche China announced that a new indication for its targeted anti-cancer drug, entretinib, had been officially approved by the NMPA. It is for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Entratinib became the first ROS1 inhibitor with clear central nervous system (CNS) efficacy approved in China.

[Application]

2. On August 17, the CDE accepted Kyowa Kirin's marketing application for evocalcet tablets. It is for the treatment of the secondary hyperparathyroidism of chronic kidney disease. Evocalcet, a next-generation oral calcium-sensitive receptor agonist (calcimimetics), was first approved for marketing in Japan in March 2018.

3. On August 18, the CDE official website revealed that Daiichi Sankyo's marketing application for Trastuzumab deruxtecan, an ADC drug, had been formally accepted by the CDE. It is for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior systemic therapy in the metastatic disease stage, or who have relapsed during or within 6 months after the completion of the adjuvant chemotherapy.

4. On August 18, the CDE official website revealed that Boehringer Ingelheim's marketing application for a new indication for Jardiance tablets was accepted. The expected indication is reducing the risk of cardiovascular death in patients with type 2 diabetes and cardiovascular diseases. Jardiance is an oral once-daily, highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor.

NMPA – Clinical Trials

[Approval]

5. On August 15, Hengrui announced that its clinical trial application for HRS-5965 tablets had been approved. It is for primary or secondary glomerular diseases mediated by such complements as IgA nephropathy, idiopathic membranous nephropathy, C3 nephropathy, and lupus nephritis. Preclinical study shows that it has a significant therapeutic effect and good safety in the nephritis model of rats.

6. On August 16, the CDE official website revealed that Novo Nordisk's dual mechanism of action, compound CagriSema injection, had been approved for clinical use. It can be taken as an adjunctive treatment to reduce the caloric diet and increase physical activity in the weight management of adult patients with an initial body mass index (BMI) ≥30kg/m2 (obese) or ≥27kg/m2 to <30kg/m2 (overweight) and with at least one weight-related comorbidity.

7. On August 16, the CDE official website announced that MSD's first-in-class, MK-4830 injection, was granted a clinical trial implied license. It will be developed for the treatment of advanced solid tumors. Public data show that MK-4830 is an ILT4 inhibitor under research, Phase II clinical trials of which are being conducted overseas.

8. On August 16, the CDE announced that ZGGS18 for injection, a first-in-class drug declared by Zelgen, was granted a clinical trial implied license. It is intended for the treatment of advanced solid tumors. Public data show that this is a recombinant humanized anti-VEGF/TGF-β bifunctional antibody fusion protein. The clinical trials for the treatment of advanced solid tumors have been approved in the United States in July 2022.

9. On August 17, Dragon Boat Biopharmaceutical announced that the clinical trial application for its self-developed BC007 antibody injection treating advanced solid tumors had been approved by the NMPA. This is the first and only CLDN18.2/CD47 bispecific antibody approved for clinical use in the world. On July 29, it was approved for clinical use by the FDA.

[Application]

10. On August 16, the CDE official website revealed that the clinical trial application of JSKN003 injection by Alphamab Oncology for the treatment of solid tumors had been accepted and became the first Chinese bispecific antibodies ADC declared for clinical use. JSKN003, a bispecific antibodies ADC targeting HER2 developed by Alphamab Oncology, was designed and modified based on KN026, a HER2 bispecific antibody.

11. On August 16, the CDE official website revealed that the clinical trial application for JCXH-211 injection by Immorna for treating cancers was accepted. It is the first novel drug of encoding human interleukin-12 (hIL-12) based on the self-replicating mRNA declared for clinical use in China. JCXH-211 is a self-replicating mRNA with differentiated advantages which allows the long-term expression of IL-12 in vivo and is potentially suitable for the treatment of various solid tumors.

12. On August 17, Junshi Biosciences announced that its clinical trial application for JS015 had been submitted to the NMPA and was accepted. According to the announcement, JS015 is its independently developed recombinant humanized anti-DKK1 monoclonal antibody injection, which is mainly for the treatment of advanced malignant solid tumors. No similar target product has been approved for marketing at home and abroad at present.

[Priority Review]

13. On August 15, the CDE official website revealed that it was proposed to include Sanofi's avalglucosidase alfa in the priority review. It is for long-term enzyme replacement therapy for patients with Pompe disease (acid alpha-glucosidase [GAA] deficiency). Avalglucosidase alfa is a highly effective enzyme replacement therapy that targets the mannose 6-phosphate (M6P) receptor, thereby improving the delivery of GAA to muscle cells.

[Breakthrough therapy]

14. On August 17, the CDE revealed that it had been proposed to include BBM-H901 injection in the breakthrough therapy. The injection is independently developed by Xinzhi Pharmaceutical, a wholly owned subsidiary of Belief BioMed and is intended to be used to prevent bleeding in adult male patients with hemophilia B (congenital coagulation factor IX deficiency). As a single intravenous dose drug of adeno-associated virus (AAV) hemophilia B gene therapy under research, its Phase I/ II clinical trials are being conducted in China.

FDA - Marketing

[Application]

15. On August 16, Roche announced that the FDA has accepted the supplemental biologics license application (sBLA) for Polatuzumab vedotin (Polivy). It will be combined with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP regimen) for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have not received prior therapy. The expected PDUFA date is April 2, 2023.

16. On August 17, GSK announced that the FDA has accepted the new drug application (NDA) for Momotinib to treat patients with myelofibrosis and the expected PDUFA date is June 16, 2023. Momelotinib is a potential new drug targeting JAK1, JAK2, and ALK2 with a differential mechanism of action, which can improve systemic symptoms and splenomegaly by inhibiting JAK1 and JAK2.

[Priority Review]

17. On August 16, AstraZeneca/MSD announced that the supplemental new drug application (sNDA) for olaparib in combination with abiraterone and prednisone/prednisolone had been accepted and the priority review had been granted by the FDA. It is for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and the PDUFA date is the fourth quarter of 2022.

R&D

Clinical trials launching

18. On August 16, Salubris announced that it had completed all patient enrollment for its self-developed S086 tablets in Phase III clinical trials. It is for the treatment of patients with mild to moderate essential hypertension. S086 (Allisartan Isoproxil + Sacubitril) is the second ARNi small-molecule pharmaceutical chemical in the clinical trial phase in worldwide. For its target indications are hypertension and chronic heart failure, both are in the Phase III clinical research.

Clinical data release

19. On August 15, AstraZeneca/Daiichi Sankyo jointly announced the clinical success of Trastuzumabderuxtecan (DS-8201) in the DESTINY-Breast02 Phase III trial for the treatment of patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1), meeting the primary endpoint. It is a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the T-DXd group compared to the standard therapy. The trial also met the key secondary endpoint of improved overall survival (OS).

20. On August 15, Novartis announced that the Phase III CANOPY-A study evaluating adjuvant treatment with Canakinumab (ACZ885) in adult patients with stage II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) did not meet the primary endpoint of disease-free survival (DFS). Canakinumab is a fully human monoclonal antibody, which is an interleukin-1β (IL-1β) inhibitor.

21. On August 15, Clene announced that the Phase II VISIONARY-MS trial of the nano-therapy CNM-Au8 for the treatment of relapsing remitting multiple sclerosis (RRMS) had met its primary endpoint of the improvement in best corrected-low contrast letter acuity (BC-LCLA). In addition, the trial met the secondary endpoint of the improvement in adjusted composite scores of functions.

22. On August 16, Palatin announced that the interim analysis of the pivotal Phase III MELODY-1 study of its melanocortin receptor agonist PL9643 eye drops for the treatment of patients with moderate to severe dry eye disease was positive and did not identify any safety concerns. Based on the positive result, the DMC recommended that Palatin should continue the study and enroll 230 new patients.

23. On August 17, Sanofi announced that the Phase III AMEERA-5 trial evaluating Amcenestrant in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer did not meet the primary endpoint. Thus, Sanofi is discontinuing the global clinical development program for Amcenestrant, an investigational oral selective estrogen receptor degrader (SERD) targeting ER that is under research.

Business

24. On August 18, Jemincare announced that Shanghai Jiyu had entered into an exclusive license agreement with Genentech to grant its exclusive development and commercialization rights of JMKX002992. JMKX002992 is a new oral AR degradation agent independently developed by the Shanghai Jiyu Institute of Small Molecule Innovation Research.