Drug Marketing in China and Worldwide (June)

NMPA

1. On June 1, NMPA official website revealed that Ethyl Icosapentate soft capsule, Class 5.1 chemical drug from Ceclor Pharmaceutical, a subsidiary of Yiteng, had been approved for marketing for reducing the TG level of adult patients with severe VHTG (≥500mg/dL). The drug, a monomolecular prescription drug containing highly purified active ingredient IPE developed by Amarin, has been approved for marketing by FDA under the brand name Vascepa, and Yiteng has the right to develop and commercialize in Greater China. 

2. On June 2, NMPA official website revealed that CANbridge's Class 5.1 chemical drug Maralixibat Oral Solution (Code: CAN108) had been approved for marketing for treating cholestatic pruritus in patients aged 1 year and above with Alagille syndrome. CAN108 is an oral, once-a-day IBAT inhibitor developed by Mirum Pharmaceuticals. 

20. On June 2, NMPA official website revealed that GSK's Class 5.1 chemical drug Dolutegravir Dispersible Tablet (brand name: Tivicay) had been approved for marketing for treating pediatric HIV-1 infection. Dolutegravir (brand name: Tivicay), an HIV integrase inhibitor, can block HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells. 

3. On June 2, NMPA official website revealed that Qilu Pharmaceutical's Class 4 chemical drug Apremilast Tablet had been approved for marketing for treating adult patients with moderate to severe plaque psoriasis who meet the indications of phototherapy or systemic therapy, which is the second generic drug of Apremilast approved for marketing in China. Apremilast is an oral small molecule PDE4 inhibitor, originally developed by Amgen. 

4. On June 2, NMPA official website revealed that Yangtze River's Class 3 chemical drug Peramivir Injection had been approved for marketing for treating influenza A and B. The original peramivir, a cyclopentane anti-influenza virus drug originally developed by Biocryst Pharmaceuticals, was approved by the FDA in 2014, which is the only anti-influenza injection approved by the FDA. 

5. On June 5, NMPA official website revealed that the new indication of Ustekinumab Injection (brand name: Stelara, specification: 45mg/0.5ml/injection) from Janssen, a subsidiary of Johnson & Johnson, had been approved for treating the moderate and severe plaque psoriasis in children and adolescents aged 6 and above (weighing 60 kg to 100 kg) who have insufficient or intolerable response to other systemic treatments or phototherapy. The drug has been approved for treating the moderate to severe plaque psoriasis in adults before. Ustekinumab is a fully humanized "double-targeted" IL-12 and IL-23 inhibitor. 

6. On June 13, NMPA official website revealed that the third indication of AstraZeneca's Eculizumab Injection (brand name: Soliris) had been approved for treating the refractory gMG adult patients with anti-AChR antibody positive. The two indications approved before are PNH and aHUS. Eculizumab Injection is a C5 complement inhibitor. 

7. On June 26, NMPA official website revealed that AstraZeneca's Class 5.1 chemical drug Dapagliflozin And Metformin Hydrochloride Extended-Release Tablet (brand name: XigduoXR) had been approved for marketing for treating T2D. XigduoXR, a compound formulation of SGLT2 inhibitor/metformin hydrochloride sustained release tablet, was approved for marketing by FDA in October 2014. Its another indication is T2D complicated with chronic kidney disease with moderate renal dysfunction (estimated eGFR is 45-59mL/min/1.73m2).

8. On June 26, NMPA official website revealed that the new indication of Hengrui Pharmaceuticals' Class 1 chemical drug Dalpiciclib Isetionate Tablets (R&D code: SHR6390) had been approved for combining aromatase inhibitor as the initial treatment for locally advanced or metastatic breast cancer with HR positive and HER2 negative. The drug is an oral, efficient and selective small molecule CDK4/6 inhibitor self-developed by Hengrui, and was marketed in China in December 2021 for combining with Fulvestrant to treat recurrent or metastatic breast cancer with HR positive and HER2 negative after endocrine therapy. 

9. On June 26, NMPA official website revealed that the new indication of CSTONE Pharmaceuticals' Class 1 chemical drug Pralsetinib Capsules (brand name: Gavreto) had been approved for the first-line treatment of locally advanced or metastatic NSCLC patients with RET fusion-positive. Pralsetinib is an oral, once a day, potent and highly selective RET inhibitor developed by Blueprint. In June 2018, CSTONE Pharmaceuticals got its exclusive right to develop and commercialize in Greater China. 

10. On June 26, NMPA official website revealed that the new indication of Fosun Kite's Class 3 therapeutic biological product Axicabtagene Ciloleucel Injection (brand name: Yescarta) had been approved for adult large B-cell lymphoma (r/rLBCL) that fails to respond to first-line immunotherapy or recurs within 12 months after first-line immunotherapy. Axicabtagene Ciloleucel injection is a genetically modified autologous CAR-T cell injection targeting CD19 developed by Gilead./Kite. In 2017, Fosun Kite obtained its all technical authorization. 

11. On June 26, NMPA official website revealed that Teva's Class 5.1 chemical drug Glatiramer Acetate Injection had been approved for marketing for multiple sclerosis. Glatiramer Acetate is a peptide copolymer mixture composed of four amino acids (glutamic acid, lysine, alanine and tyrosine). The drug was first approved by the FDA in 1996, with two dosages, 20mg and 40mg, which it needs one injection each day for the former and three injections each week for the latter.

12. On June 28, NMPA official website revealed that Qilu Pharmaceutical's Class 1 chemical drug lruplinalkib Tablets (Former name: Iroquois, R&D code: WX-0593) had been approved for marketing for the treatment of locally advanced or metastatic NSCLC patients with ALK positive and with disease progression or intolerance to crizotinib after previous treatment. Lruplinalkib is a new ALK/ROS1 inhibitor developed by Qilu. 

13. On June 29, NMPA official website revealed that Chiatai Tianqing's Class 3 chemical drug Lubiprostone soft capsule had been approved for marketing, being the first generic drug. Lubiprostone, a secretagogue, acts on the type 2 chloride ion channel of intestinal epithelium and improves constipation symptoms by promoting the secretion of intestinal fluid and accelerating intestinal transport. The drug has been approved abroad for more than 10 years, and the approved indications include chronic idiopathic constipation and constipation-type irritable bowel syndrome. 

14. On June 29, NMPA official website revealed that Yiteng's Class 5.1 chemical drug Lusutrombopag Tablet (brand name: Mulpleta) had been approved for marketing for adult patients with chronic liver disease and thrombocytopenia who plan to undergo surgery (including diagnostic operation). Lusutrombopag is an oral, small molecular human thrombopoietin receptor agonist, which has been approved for marketing in America, the EU and Japan. In June 2019, Yiteng reached a cooperation with Shionogi and obtained the exclusive authorization of Lusutrombopag in Chinese mainland, Hongkong and Macau. 

15. On June 29, NMPA official website revealed that SinoCellTech's Class 3.3 therapeutic biological product Bevacizumab Injection had been approved for marketing. The original drug of bevacizumab developed by Roche was marketed in the US in 2004 and in China in 2010, with the approved indications of hepatocellular carcinoma, NSCLC, colorectal cancer, cervical cancer and ovarian cancer. 

16. On June 29, NMPA official website revealed that Ruikangdi's Class 5.1 chemical drug Carglumic Acid Dispersible Tablet had been approved for marketing for treating hyperammonemia in adults and pediatric patients caused by various factors. Carglumic Acid Dispersible Tablet is a blood disease therapeutic drug for Recordati Rare Diseases, and its active ingredient, carglumic acid, is a synthetic structural analogue of NAG. 

FDA 

1. On June 8, FDA's website revealed that Novaliq's new drug 0.1% Cyclosporin A preparation (SHR8058, brand name: CyclASol) had been approved for marketing for dry eye disease. In November 2019, Hengrui reached an agreement with Novaliq to obtain the exclusive right to develop, produce and sale the drug in China. In February 2023, Hengrui Pharmaceuticals has applied to NMPA for the marketing of SHR8058. 

2. On June 15, FDA's website revealed that glofitamab-gxbm (brand name: Columvi) from Genentech, a subsidiary of Roche, had been approved for marketing for treating adult patients with R/R DLBCL or LBCL caused by follicular lymphoma who have undergone second-line or multi-line systematic treatment. Columvi is a bispecific antibody that targets both CD3 and CD20. 

3. On June 12, FDA's website revealed that Leadsbiolabs' Class 1 biological product LBL-033 for injection had been approved for phase I/II clinical trial, which is intended to treat malignant tumors such as ovarian cancer. LBL-033 is a bispecific anti-MUC16/CD3 antibody targeting both tumor cells expressing MUC16 and T cells expressing CD3. The drug has been approved for clinical in China before, and the first administration was given to the subject in April 2023 at the Cancer Center of Sun Yat-sen University. 

4. On June 14, FDA's website revealed that Mabwell's Class 1 biological product 9MW3811 Injection had been approved for clinical treatment for idiopathic pulmonary fibrosis. 9MW3811, a humanized monoclonal antibody targeting IL-11 developed by Mabwell, can effectively block the activation of downstream signaling pathway of IL-11 and inhibit the pathophysiological function induced by IL-11, thus achieving the therapeutic effect on fibrotic diseases and tumors. 

5. On June 27, FDA's website revealed that UCB Pharma's subcutaneous injection of FcRn monoclonal antibody targeting the newborn, Rozanolixizumab (brand name: Rystiggo) had been approved for marketing for treating adult generalized myasthenia gravis (gMG) with anti-AChR or anti-MuSK antibody positive. 

6. On June 28, FDA's website revealed that CellTrans allogeneic islet cell therapy Lantidra had been approved for marketing for the treatment of adult patients with type 1 diabetes. Although these patients have been treated and educated for diabetes, they can't reach the target glycosylated hemoglobin level because of the repeated severe hypoglycemia. Lantidra plays a therapeutic role by injecting insulin secreted by allogeneic islet β-cells. 

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.