The Marketing Approval for GSK's Two-Drug HIV Treatment in China

Drug Review

NMPA – Marketing

[Approval]

1. On October 21, the NMPA official website revealed that a new indication for Tofacitinib Citrate Sustained Release Tablets of Pfizer was approved for marketing. Tofacitinib is a JAK inhibitor developed by Pfizer, with approved indications worldwide for rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. In August 2021, the sustained-release tablet formulation was approved for marketing in China, making it the first once-daily sustained-release tablet approved in China for tofacitinib. On the same day, according to the NMPA, the Class 3 generic drug Tofacitinib Citrate Sustained Release Tablets of CSPC Pharmaceutical were also approved for marketing, which is the second generic tofacitib sustained release tablet marketed in China.

2. On October 21, the NMPA official website revealed that Dolutegravir Edurant Tablets of GSK were approved for marketing, which is used for adult human immunodeficiency virus type 1 (HIV-1) infected patients who have achieved virological suppression (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least six months, have no history of virological failure, and have no known or suspected resistance to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors.

NMPA – Marketing

[Application]

3. On October 18, the CDE official website revealed that the human anti-autologous CAR-T product, Zevorcabtagene Autoleucel Injection of CARsgen, was submitted for a marketing application for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have failed previous treatment with at least one immunomodulator and a proteasome inhibitor. This is also the second BCMA CAR-T product to be declared for marketing in China.

4. On October 20, the CDE official website revealed that the second indication of Dalpiciclib Isetionate Tablets of Hengrui Medicine was submitted for marketing, which is indicated for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with aromatase inhibitors as initial treatment. Dalpiciclib is an oral, effective, and highly selective small molecule CDK4/6 inhibitor independently developed by Hengrui Medicine.

5. On October 21, the CDE official website revealed that the Liraglutide Injection of Chiatai Tianqing was submitted a marketing application with a predicted indication of diabetes, which is the fourth liraglutide injection made in China to be declared for marketing. Liraglutide, an analogue of GLP-1, is an important target for the treatment of diabetes with the following physiological functions: Blood glucose dependence promotes insulin secretion, protects pancreatic β cells, delays gastric emptying, reduces appetite, etc. The original liraglutide drug was developed by Novo Nordisk.

NMPA – Clinical Trials

[Approval]

6. On October 17, the CDE official website revealed that HBW-3210 Capsules of Hyperway Pharm were approved clinically in China, to be developed for the treatment of B-cell non-Hodgkin's lymphoma. HBW-3210 Capsule is a strong brain-permeable, reversible anti-drug-resistant third-generation BTK inhibitor developed by Hyperway Pharm, intended for use in B-cell non-Hodgkin's lymphoma, with primary/secondary central nervous system lymphoma (PCNSL/SCNSL) or diffuse large B-cell lymphoma (DLBCL) with possible involvement of the central nervous system as the primary indication for development.

[Application]

7. On October 19, the CDE official website revealed that the 9MW3011 Injection of Mabwell was declared for clinical use. 9MW3011 is an innovative target monoclonal antibody independently developed by Mabwell, whose target is mainly expressed on the surface of the hepatocyte membrane. The proposed indications for 9MW3011 include a variety of rare diseases such as β-thalassemia and true erythrocytosis, which are closely related to iron homeostasis.

8. On October 21, the CDE official website revealed that the Remternetug Injection of Eli Lilly was declared clinically for the treatment of Alzheimer's disease (AD). Remternetug is a successor to Donanemab, which demonstrated deep plaque clearance capability in the Phase Ib clinical trial conducted and has a favorable safety profile. Donanemab is a drug under development by Eli Lilly that targets a modified β-amyloid plaque antibody known as N3pG and was previously recognized by the FDA as a breakthrough therapy.

[Priority Review]

9. On October 17, the CDE official website revealed that the marketing application for Sciencare Pharmaceutical’s Naltrexone Implant is proposed to be included in the priority review for relapse after detoxification for patients with opioid dependence. Naltrexone is an opioid receptor antagonist, and its binding activity to opioid receptors is more than 30 times that of heroin's opioid drugs, so naltrexone in the body can effectively antagonize the vast majority of opioid receptors when it reaches a certain concentration.

[Breakthrough Therapy]

10. On October 20, the CDE official website revealed that Hengrui Medicine’s PD-1 monoclonal antibody Camrelizumab for Injection and multi-target tyrosine kinase inhibitor famitinib malate capsules are proposed to be included in the breakthrough therapy varieties. The combination of both drugs is used in the first-line treatment of recurrent or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression in tumor cells (TPS ≥ 1%) and without EGFR/ALK gene abnormalities.

11. On October 20, the CDE official website revealed that a clinical trial application for AK112 Injection of Akeso is proposed to be included in the breakthrough therapy varieties. The indications to be developed include combination chemotherapy for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation that has failed trans-epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy. AK112 is a humanized anti-PD-1/VEGF bispecific antibody.

R&D

Clinical trials Status

12. On October 17, Bayer announced the initiation of the Phase III OASIS 4 study of Elinzanetant for the treatment of vasodilatory symptoms (VMS) caused by endocrine therapy in patients with breast cancer and women at high risk for breast cancer. Elinzanetant is a first-in-class, once-daily oral, non-hormonal, neurokinin-1,3 receptor (NK1R, NK3R) antagonist for the treatment of nutritional, metabolic, endocrine, and sex hormone-related disorders in women.

13. On October 19, the official website of the Drug Clinical Trial Registration and Information Publicity Platform of CDE announced that HEC initiated a Phase III clinical trial to evaluate the efficacy and safety of the Tablets for the treatment of relapsed/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation. The Tablets are a new generation, highly specific FLT3 inhibitor, a first-in-class developed by HEC.

Clinical data release

14. On October 17, Innovent announced the results of a high-dose cohort of the Phase Ib clinical research of the GLP-1R/GCGR dual agonist mazdutide in multiple-dose increments in Chinese overweight or obese subjects. Mazdutide's high-dose clinical Phase I results made it the first single drug in the world to achieve a weight loss of more than 11.5% at 12 weeks of dosing. Mazdutide was developed by Eli Lilly, and in August 2019, Innovent entered into a strategic partnership with Eli Lilly to advance the development and commercialization of mazdutide in China.

15. On October 17, Kiora announced positive results from a Phase I study of KIO-100 in non-infectious uveitis, in which a single intravitreal injection of KIO-100 reduced intraocular inflammation in a dose-dependent manner and significantly improved visual acuity. KIO-100 is a non-steroidal anti-inflammatory drug known as a dihydroorotate dehydrogenase (DHODH) inhibitor. Uveitis is a T-cell-mediated inflammatory disease in the eyes that predisposes to blindness.

16. On October 18, Teva announced the latest results of an approximately 3-year ARC-HD trial of Deutetrabenazine (brand name: Austedo) for the treatment of chorea associated with Huntington's disease. Studies have shown that long-term use of Deutetrabenazine is safe and well tolerated in patients with chorea associated with Huntington's disease. Huntington's disease (HD) is a rare and fatal neurodegenerative disease.

17. On October 19, Providence, a partner of Everest Medicines, released the Phase II clinical PRO-CL-002 data of the new mRNA vaccine for COVID-19, PTX-COVID19-B. The results showed that PTX-COVID19-B achieved statistically non-inferiority compared to Pfizer/BioNTech's mRNA vaccine Comirnaty, with respect to the geometric mean titer (GMT) ratio of neutralizing antibodies observed two weeks after the second of two intramuscular injections. Additionally, its safety and tolerability are also similar to Comirnaty.

18. On October 19, Incyte released updated data from its pivotal Phase III TRuE-V trial programme assessing Ruxolitinib Cream (Opzelura) 1.5% in patients 12 years old and older with nonsegmental vitiligo. The results showed a higher proportion of vitiligo patients with facial and total body repigmentation after 52-week ruxolitinib treatment compared to previously published data of the 24-week treatment.

19. On October 19, BMS announced the latest results of the Phase III CheckMate-76K study. The study aimed to evaluate the efficacy and safety of PD-1 monoclonal antibody Opdivo in the adjuvant treatment of patients with completely resected Phase IIB/IIC melanoma. The results showed that the Opdivo (nivolumab) group had significantly longer recurrence-free survival (RFS) than the placebo group.

20. On October 17, Milestone Pharmaceuticals announced that the Phase III RAPID study of Etripamil in the treatment of paroxysmal supraventricular tachycardia has achieved positive results, and plans to submit a marketing application in mid-2023. Etripamil, a novel calcium channel blocker and a self-administered nasal spray that patients can use at home, is expected to change the treatment paradigm for PSVT.

Listing

21. On October 18, the official website of the STAR Market of Shanghai Stock Exchange announced that Hrain Biotechnology had submitted an IPO application and was accepted. The company plans to adopt the fifth set of listing standards for its IPO on the STAR market. At present, Hrain Biotechnology has built a product pipeline including 11 projects under development, covering CAR-T, CAR-NK, and DASH CAR-T. Among them, the clinical trial application of the CD19-targeted CAR-T product HR001 has been included in the priority review, and the new drug application is expected to be submitted in 2023.