The Marketing Approval of Luye Pharma’s First-in-class Anti-depressant Drug in China

Drug Review

NMPA – Marketing

[Approval]

1. On October 31st, the NMPA official website revealed that the new indication of PD-1 Monoclonal Antibody Serplulimab Injection developed by Henlius had been approved for marketing, intended for the combination chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). This is the second indication of Serplulimab approved after MSI-H solid tumor.

2. On November 1st, the NMPA official website revealed that Chiral-tech's generic drug of Eliglustat Tartrate Capsule had been approved for marketing for the long-term treatment of adult patients with Gaucher's disease whose cytochrome P4502D6 (CYP2D6) genotypes are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs) 1. The original product is a potent and highly specific oral ceramide analogue inhibitor.

3. On November 3rd, the NMPA official website revealed that Toludesvenlafaxine Hydrochloride Extended-Release Tablets (brand name: Ruoxinlin), a first-in-class drug developed by Luye Pharma, had been approved for marketing for the treatment of depression. The antidepressant effect of Toludesvenlafaxine Hydrochloride may be relevant to the enhancement of 5-hydroxytryptamine (5-HT) and norepinephrine (NE) in the central nervous system by inhibiting the reuptake of 5-HT and NE.

NMPA – Marketing

[Application]

4. On November 2nd, the CDE official website revealed that Risperidone Oral Soluble Film, a new drug developed by Qilu Pharmaceutical, had been declared for marketing to treat schizophrenia. Qilu Pharmaceutical thus became the first pharmaceutical company to submit a marketing application for this drug. Risperidone is a benzisoxazole derivative, a first-choice drug in the first-line treatment guidelines of schizophrenia.

5. On November 3rd, CDE’s official website revealed that Salubris' 2.3 new drug Allisartan Isoproxil-Amlodipine Tablets had been declared for marketing. Allisartan Isoproxil-Amlodipine Tablets are a kind of compound formulation drug, intended for patients with essential hypertension whose blood pressure is poorly controlled after Allisartan Isoproxil or amlodipine monotherapy.

NMPA – Clinical Trials

[Approval]

6. On November 1st, the CDE official website revealed that Eli Lilly's clinical trial application of Peresolimab Injection had been approved for the treatment of moderate and severe active rheumatoid arthritis. Peresolimab is a PD-1 agonist with "first-in-class" potential, which can bind PD-1 and inhibit lymphocyte activation and expansion as its agonist.

7. On November 1st, the CDE official website revealed that Eli Lilly's clinical trial application of LOXO-783 tablets had been approved for the treatment of advanced breast cancer and other solid tumors with PIK3CAH1047R mutation. LOXO-783 is a PI3KαH1047R inhibitor under research and undergoing Phase I clinical trials overseas.

8. On November 1st, the CDE official website revealed that the clinical trial application of AK129 injection of Akeso, Inc. had been approved for the treatment of malignant tumors. AK129 is a PD-1/LAG-3 bispecific antibody, also the third new bispecific antibody drug independently developed by the company.

9. On October 31st, the CDE official website revealed that Alphamab Oncology's registered clinical trial application for Phase III of KN026 combined with KN046 had been approved, intended for the treatment of HER2 positive locally progressive unresectable or metastatic gastric/gastroesophageal junction cancer (GC/GEJ). KN026 is a HER2 bispecific antibody and KN046 is a PD-L1/CTLA-4 bispecific antibody, both developed by Alphamab Oncology.

[Application]

10. On November 1st, the CDE official website revealed that AZD2693 of AstraZeneca had been declared for a clinical trial in China, and its indication was nonalcoholic steatohepatitis (NASH). AZD2693 is an oligonucleotide therapy targeting patatin-like phospholipase structural domain protein 3 (PNPLA3) gene developed by Ionis Pharmaceuticals, using its ligand conjugated antisense (LICA) technology platform and the 2.5th generation chemical technology.

11. On November 2nd, CDE’s official website revealed that SAR443122 Hard Capsules developed by Sanofi had been applied for clinical practice in China. SAR443122 is a peripheral selective small molecule inhibitor of RIPK1. RIPK1 is considered a promising target, expected to bring innovative therapeutic drugs to nervous system diseases and systemic inflammatory diseases.

[Breakthrough Therapy]

12. On November 3rd, the CDE official website revealed that the new indication of Pyrotinib Maleate Tablets developed by Hengrui Medicine had been proposed to be included as a breakthrough therapy, intended, in combination with Trastuzumab and Docetaxel for the treatment of recurrent or metastatic breast cancer patients with positive epidermal growth factor receptor 2 (HER2) and who had not received anti-HER2 treatment in an advanced stage. Pyrotinib is the first HER1/HER2/HER4 targeted drug independently developed in China.

FDA – Clinical Trials

[Approval]

13. On October 31, Antengene Corporation announced the FDA approval of the Phase I clinical trial application to evaluate the safety, pharmacokinetics, and preliminary efficacy of ATG-017 combined with PD-1 inhibitor Nivolumab in the treatment of advanced solid tumors. ATG-017 is a selective oral small molecule inhibitor of extracellular signal-regulated kinase 1 and 2 (ERK1/2).

14. On November 1, Abbisko announced that the first international human Phase I clinical trial of ABSK121 for the treatment of advanced solid tumors had been approved by the FDA. ABSK121 is a second-generation small molecule FGFR inhibitor with oral administration, high activity, and selectivity, and able to overcome drug resistance mutation.

[Breakthrough Therapy]

15. On November 1st, Rhythm Pharmaceuticals announced that Setmelanotide had been granted the qualification of breakthrough therapy by the FDA for the treatment of hypothalamic obesity. Setmelanotide is a "First-in-class" melanocortin-4 receptor (MC4R) agonist, which was first approved by the FDA in November 2020.

[Fast Track Designation]

16. On October 31, Grandpharma announced that ITM-11, intended for the treatment of gastrointestinal and pancreatic neuroendocrine tumors, had been granted Fast Track Designation by the FDA. ITM-11 is a peptide receptor radionuclide therapy developed by ITM Company, under Phase III clinical research overseas. Grandpharma owns the exclusive rights and interests of this drug in Greater China.

EMA – Marketing

[Approval]

17. On November 2, BeiGene announced that EMA had granted the marketing license of BTK inhibitor Zanubrutinib to treat adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who had received at least one anti-CD20 therapy before. This approval applies to all 27 Member States of the European Union (EU), as well as Iceland and Norway.

R&D

Clinical trials Status

[Initiation]

18. On October 31, the Drug Clinical Trial Registration and Information Publicity Platform of CDE revealed that AstraZeneca had launched a Phase IIb/III international multicenter (including China) clinical trial to evaluate the safety and efficacy of Cotadutide in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with fibrosis. Cotadutide is a double agonist of GCGR and GLP-1R.

[Termination]

19. On October 31, Inventiva announced that it had decided to terminate the development of Cedirogant (ABBV-157) based on the analysis of a recently concluded non-clinical toxicology study. ABBV-157 is an oral RORγ reverse agonist jointly developed by Inventiva and AbbVie, intended for the treatment of autoimmune diseases.

Clinical data release

20. On October 31, Sanofi announced that the key phase III clinical research of Dupilumab in adult and adolescent asthma patients in the Asia-Pacific region had achieved positive results, reaching the primary endpoints and the key secondary endpoints. The results indicated that Dupilumab can significantly improve asthma patients' lung function, better asthma control, and reduce acute attacks. Dupilumab is a monoclonal antibody that can inhibit IL-4 and IL-13 at the same time.

21. On October 31, RemeGen announced the completion of the domestic Phase II clinical research of Telitacicept (brand name: Tai'ai) in the treatment of systemic myasthenia gravis (gMG). The results indicated that Telitacicept can significantly improve the state of systemic myasthenia gravis with good safety. Telitacicept is an antibody fusion protein drug molecule, which inhibits the overexpression of BLyS and APRIL cytokines.

22. On October 31st, Akeso, Inc. announced the release of the Ib phase clinical research data of AK112 combined with etoposide and carboplatin in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). The results indicated that in the first-line treatment of ES-SCLC, AK112 combination chemotherapy has excellent anti-tumor efficacy and survival benefits, as well as good safety. AK112 is the world's first PD-1/VEGF bispecific antibody to enter into clinical research independently developed by Akeso, Inc.

23. On October 31st, Actinium Pharmaceuticals announced that the key phase III SIERRA study of Iomab-B for the treatment of relapsed or refractory acute myeloid leukemia (r/rAML) had reached the primary endpoints. Iomab-B (initial R&D code: BC8) is a radioimmunotherapy targeting CD45 developed by Fred Hutchinson Cancer Research Center.

24. On November 1, Akeso, Inc. announced success in the Phase III clinical research of Inusimab developed in cooperation with Dawnrays Pharmaceutical for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia, HeFH) and mixed hyperlipidemia, which had reached the preset endpoint. Inusimab is a PCSK9 monoclonal antibody jointly developed by Akeso, Inc. and Dawnrays Pharmaceutical, intended for the treatment of primary hypercholesterolemia and mixed hyperlipidemia.

Business

25. On October 31st, SonnetBio announced that it had reached a cooperation agreement with Janssen, a subsidiary of Johnson & Johnson, on three candidate products: SON-1010, SON-1210, and SON-1410. Janssen will conduct head-to-head research on the candidate products in combination with its cell therapy. SON-1010 is a special structure of IL-12 developed by FHAB technology. SON-1210 can connect IL-12 and IL-15, two kinds of active ingredients, and SON-1410 can connect IL-18 and IL-12.