Monthly Pharma News Review of PharmaSources (February) - Chinese Drug review and approval

In February, in terms of drug review and approval, domestically, the anti-PD-L1 monoclonal antibody Adebrelimab from Hengrui Pharmaceuticals was approved for marketing, and the Class 3 chemotherapy Limaprost tablets from Sino Biopharm were approved for marketing, targeting common diseases in the middle-aged and elderly.

1. On February 20, the NMPA official website revealed that Class 3 chemical drug Limaprost Tablets (brand name: Keliton) from Sino Biopharm was approved for marketing in the field of analgesia and microcirculation treatment. Limaprost Tablets are the only small-molecule drug with clear indications for the treatment of lumbar spinal stenosis in the clinical manual, and are the first drug in China to address the pathological mechanism of lumbar spinal stenosis, with the dual effects of improving neural blood flow microcirculation disorders and improving neurological function, as the basic drug for the whole management of lumbar spinal stenosis.

2. On February 20, NMPA official website revealed that Nitisinone capsules as well as oral suspension of Sobi Pharmaceuticals were approved for marketing for the treatment of hereditary tyrosinemia type I (HT-1) in adults and pediatric patients (of any age) and for the indication of combining tyrosine and phenylalanine dietary restrictions. Nitisinone, developed by Orphan BiovitrumAB of Switzerland, is a reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase.

3. On February 20, the NMPA official website revealed that the Upadacitinib Sustained Release Tablets from AbbVie were approved for marketing fourth indication for the treatment of adult patients with moderately severe active ulcerative colitis (UC) who have responded poorly to one or more tumor necrosis factor (TNF) inhibitors or who are intolerant or contraindicated. Upadacitinib is a self-developed JAK1 inhibitor by AbbVie, and its enzymatic activity and cellular assay results show that it inhibits JAK1 with higher potency than JAK2, JAK3 and TYK2. 

4. On February 20, the NMPA official website revealed that Amphotericin B Liposome for Injection (brand name: AmBisome) from Gilead. was approved for marketing for the treatment of invasive fungal diseases. AmBisome targets s variety of fungi including Candida, Aspergillus, Trichoderma and Cryptococcus fungi, with an overall response rate of up to 90% against Candida and rare drug resistance.

5. On February 20, the NMPA official website revealed that Human Coagulation Factor IX from Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. was approved for marketing. The approved indication is for the prevention and treatment of bleeding caused by human coagulation factor IX deficiency (hemophilia B). Hemophilia is a rare recessive hereditary bleeding disorder that can be classified into two types, hemophilia A and hemophilia B, which are both caused by mutations in the corresponding coagulation factor genes. Among them, hemophilia B is caused by a deficiency of coagulation factor IX.

6. On February 20, the CDE official website revealed that X842, which was co-developed by Shanghai Pharmaceuticals's wholly-owned subsidiary Shanghai Sine Pharmaceutical Laboratories Co., Ltd., was submitted and processed as a marketing application for the treatment of reflux esophagitis. X842 is a next-generation potassium competitive acid blocker (P-CAB) orally administered drug. In October 2021, Shanghai Pharmaceuticals acquired the exclusive contract manufacturing and industrial marketing rights for X842 in China for all indications from Sinorda Biomedicine for a transaction amount not exceeding RMB 690 million.

7. On February 20, the CDE official website revealed that the indication of the first-in-class drug Tegoprazan Tablets from Luoxin Pharmaceuticals was submitted and processed for marketing, with the new indication of duodenal ulcer. Tegoprazan is the first self-developed potassium competitive acid blocker (P-CAB) in China. In October 2015, Luoxin Pharmaceuticals entered into an agreement with CJHealthCare (South Korea) to acquire the rights to develop, manufacture and commercialize Tegoprazan in China.

8. On February 22, the CDE official website revealed that SUL-DUR from Zai Lab was submitted and processed as a marketing application for the treatment of infections caused by Acinetobacter baumannii (including multi-drug resistant and carbapenem resistant [CRAB] strains). SUL-DUR is a combination of sulbactam sodium, an intravenous infusion beta-lactam antibiotic, and dulobactam sodium, a novel broad-spectrum intravenous infusion beta-lactamase inhibitor.

9. On February 23, Gan & Lee Pharmaceuticals announced that the Biologics License Application (BLA) for Insulin Glargine Injection was processed by the FDA and entered the substantive review stage. Insulin Glargine is a long-acting insulin analogue, also known as basal insulin, which is modified to provide stable levels of plasma insulin over an extended period and requires only one injection per day.

10. On February 25, the CDE official website revealed that the first-in-class drug Tornodafil Hydrochloride Tablets from Yangtze River Pharmaceutical Group were submitted for marketing and processed for the treatment of erectile dysfunction (ED). Tornodafil hydrochloride tablets are phosphodiesterase 5 (PDE5) inhibitors. Four original PDE5 inhibitors have been marketed in China, namely sildenafil (2002/10, Pfizer), vardenafil (2004/07, GSK/Bayer), tadalafil (2004/12, Eli Lilly), and aildenafil (2021/12, Youcare Pharmaceutical).

11. On February 28, the CDE official website revealed that Sugemalimab Injection (Cejemly) from CSTONE Pharmaceuticals with combination chemotherapy was submitted and processed for a marketing application for a new indication for the first-line treatment of non-operable advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. This is also the 3rd indication for which sugemalimab has been declared in China. The drug is an anti-PD-L1 monoclonal antibody developed by CSTONE Pharmaceuticals based on the OmniRat transgenic animal platform introduced under license from Ligand, Inc.

12. On March 1, the NMPA official website revealed that Palbociclib Capsules from Sino Biopharm were approved for marketing. Palbociclib is the world's first approved CDK4/6 inhibitor, which can selectively inhibit CDK4/6, restore cell cycle control, and block tumor cell proliferation. The approved indication is locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative, and should be used in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal female patients.

13. On March 1, the NMPA official website revealed that Tedizolid Phosphate Tablets and Tedizolid Phosphate for Injection from Sino Biopharm for injection were approved for marketing. Tedizolid is a second-generation oxazolidinone antibiotic for acute bacterial skin and skin structure infections in adults caused by specific sensitive bacteria. Tedizolid phosphate, as a prodrug, is rapidly converted in vivo by phosphatase to the biologically active tertizolamide, which binds to the ribosomal 50S subunit of bacteria, thereby inhibiting protein synthesis.

14. On March 3, the NMPA official website revealed that the first-in-class drug Adebrelimab Injection from Hengrui Pharmaceuticals was approved for marketing with combination chemotherapy for the first-line treatment of extensive-stage small cell lung cancer. Adebrelimab is a humanized anti-PD-L1 monoclonal antibody self-developed by Hengrui, which can specifically bind PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance and reactivate the anti-tumor activity of the immune system, thus treating tumors.

15. On March 3, the NMPA official website revealed that HS022, a biosimilar of trastuzumab, from Hisun Biomaterials, a wholly-owned subsidiary of BioRay, was approved for marketing for the treatment of HER2-positive metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer. The original trastuzumab product is Roche Herceptin, which was previously approved in China for the treatment of breast cancer and gastric cancer.

16. On March 3, the NMPA official website revealed that TQB2302, a biosimilar of bevacizumab, from Chiatai Tianqing, was approved for marketing. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor. The original drug, Roche Anvitin, has been approved in China for the treatment of NSCLC, metastatic colorectal cancer, glioblastoma, hepatocellular carcinoma, ovarian cancer and cervical cancer, among other indications.