Drug Marketing in China and Worldwide (May)

NMPA

1. On May 8, NMPA official website revealed that AstraZeneca's Selumetinib Hydrogen Sulfate Capsule had been approved for marketing for treating patients aged 3 years and above with symptomatic and/or progressive, inoperable NF1 related PN. Selumetinib, a MEK1/2 inhibitor developed by ArrayBioPharma (a subsidiary of Pfizer), was approved for marketing for the first time in April 2020. 

2. On May 8, NMPA official website revealed that India Dr. Reddy's Laboratories' Class 5.2 chemical drug, Sevelamer Carbonate Tablet, had been approved for marketing for treating hyperphosphatemia in adult patients with CKD. Dr. Reddy's Laboratories is the fourth pharmaceutical company and the first foreign pharmaceutical company with generic drugs approved for marketing. Sevelamer carbonate, also known as cross-linked polyallylamine polymer, is a copolymer of polyacrylamide and epichlorohydrin by cross-linked polymerization. 

3. On May 9, NMPA official website revealed that Efbemalenograstim Alfa Injection (R&D code: F-627) of Evive Biotech / Chiatai Tianqing had been approved for marketing for preventing and treating neutropenia caused by tumor patients during chemotherapy. Efbemalenograstim Alfa Injection is a rhG-CSF dimer expressed by CHO cells. 

4. On May 17, NMPA official website revealed that BioRay's Zuberitamab Injection had been approved for marketing for treating adult patients with CD20-positive DLBCL and NOS, which should be combined with standard CHOP chemotherapy (cyclophosphamide, adriamycin, vincristine and prednisone). Zuberitamab (R&D code: HS006) is a human-mouse chimeric anti-CD20 monoclonal antibody. 

5. On May 17, NMPA official website revealed that Sanhome's first-in-class Alfosbuvir Tablet had been approved for marketing for combining with daclatasvir dihydrochloride to treat adult patients with genes 1, 2, 3, and 6 chronic HCV infection who are newly treated or treated with interferon, with or without compensatory cirrhosis. Alfosbuvir is an HCV NS5B polymerase inhibitor. 

6. On May 17, NMPA official website revealed that Bayer's Finerenone (brand name: Kerendia) had expanded indications for the early stage of chronic kidney disease related to T2D. Finerenone, a non-steroidal selective mineralocorticoid receptor antagonist, was approved by NMPA for the first time in June 2022 for treating the adult patients with chronic kidney disease related to T2D (25mL/min/1.73m2 ≤ eGFR < 75mL/min/1.73m2, with albuminuria), which can reduce the risk of eGFR continuous decline and end-stage renal disease.

7. On May 17, NMPA official website revealed that Eisai's Perampanel Oral Suspension had been approved for marketing for treating partial seizures of epilepsy (with or without secondary generalized seizures) in adults and children over 4 years old. Perampanel (brand name: Fycompa) is a selective and non-competitive AMPA (α - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazole propionic acid) receptor antagonist. 

8. On May 17, NMPA official website revealed that AB&B BIO-TECH's preventive biological product, Class 1 tetravalent influenza virus subunit vaccine, had been approved for marketing as an adjuvant-free tetravalent influenza virus subunit vaccine for people over 3 years old. The vaccine contains a new antigen form, with the characteristics of high purity, low inoculation side effects and good safety. 

9. On May 23, NMPA official website revealed that Bayer's copanlisib for injection had been approved for marketing for treating adult patients with recurrence or refractory follicular lymphoma (FL) who have received at least two systemic treatments in the past. Copanlisib for injection is an intravenous PI3K inhibitor which can inhibit PI3K-α and PI3K-δ kinase subtypes mainly expressed in malignant B cells at the sub-nanomolar level.

10. On May 23, NMPA official website revealed that the eleventh indication of BeiGene's Tislelizumab (brand name: Baizean) had been approved for marketing for the first-line treatment of unresectable, locally advanced, recurrent or metastatic ESCC in the combination with chemotherapy. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody. 

11. On May 23, NMPA official website revealed that Mabpharm Limited's CMAB007 for injection had been approved for marketing for treating allergic asthma. CMAB007 is a biosimilar of Omalizumab which original drug is an antibody therapeutic drug specifically targeting and blocking anti-IgE, jointly developed by Novartis and Roche. 

12. On May 23, NMPA official website revealed that the second indication of CD38 monoclonal antibody Daratumumab Injection (subcutaneous injection) of Janssen, a subsidiary of Johnson & Johnson, had been approved for marketing. The subcutaneous injection of Daratumumab can be administered in about 3 to 5 minutes, which can shorten the administration time from several hours to several minutes compared with its intravenous injection. This product has been approved for treating the patients with primary light chain amyloidosis in China before.

13. On May 30, NMPA official website revealed that China Medical System's Class 3.1 biological product Tildrakizumab Injection had been approved for marketing for treating adult patients with moderate to severe plaque psoriasis who are suitable for systematic treatment. Tildrakizumab Injection is a new monoclonal antibody specifically targeting IL-23. In June 2019, China Medical System obtained the license right to develop and sell in Greater China through cooperation with Sun Pharma. 

14. On May 30, NMPA official website revealed that Chiatai Tianqing's Class 3.3 biological product Rituximab Injection (Code: TQB2303) had been approved for marketing for treating newly diagnosed patients with DLBCL. TQB2303, an anti-CD20 monoclonal antibody, is a biosimilar of rituximab, which the original company is Roche. And the approved indications include non-Hodgkin's lymphoma, Chronic lymphocytic leukemia, maintenance treatment of follicular lymphoma, rheumatoid arthritis (RA), etc. 

15. On May 30, NMPA official website revealed that the new indication of Sanofi's Class 3.1 biological product Dupilumab Injection (brand name: Duumab) had been approved for treating for infants aged 6 months to 5 years with moderate and severe atopic dermatitis (AD). Dupilumab is a fully humanized monoclonal antibody jointly developed by Sanofi and Regeneron, which can inhibit the signal transduction of IL-4 and IL-13 proteins. 

16. On May 31, NMPA official website revealed that Betta Pharmaceuticals' Class 1 chemical drug Befotertinib Capsule (Code: BPI-D0316) had been approved for marketing for the treatment of locally advanced or metastatic NSCLC with T790M mutation after EGFR-TKI resistance. Befotertinib is a third-generation EGFR-TKI self-developed by Betta Pharmaceuticals for T790M mutation. 

17. On May 31, NMPA official website revealed that the new indication of Jardiance Tablet (brand name: OuTangJing), Class 5.1 chemical drug from Boehringer Ingelheim and Eli Lilly, had been approved for improving blood glucose control of T2D patients on the basis of diet and exercise in combination with insulin therapy (with or without oral antidiabetic drugs). The drug is an oral, once-a-day and highly selective SGLT2 inhibitor, which has been approved to treat adult T2D, adult heart failure with reduced ejection fraction and adult heart failure with preserved ejection fraction in China. 

FDA 

1. On May 9, FDA's website revealed that the new indication of AstraZeneca's Dapagliflozin (brand name: Farxiga) had been approved for marketing for reducing the risk of CV death, hospitalization due to hHF and emergency treatment of heart failure in adult patients. Dapagliflozin, a SGLT-2 inhibitor, has been approved for treating T2D, HFrEF and CKD all over the world. 

2. On May 18, Bausch & Lomb and Novaliq announced that Perfluorohexyloctane Ophthalmic Solution (brand name: MIEBO) had been approved by FDA for marketing for treating signs and symptoms of dry eye. It is a colorless and transparent eye drop, which is composed of 100% perfluorohexyloctane and can quickly spread to the whole eye surface. Hengrui Pharmaceuticals has the exclusive right of the drug in China, and has submitted its marketing application in China. 

3. On May 18, the new indication of AbbVie's Upadacitinib (brand name: Rinvoq) was approved by FDA for treating adult patients with moderate to severe active Crohn's disease who are unresponsive or intolerant to one or more TNF blockers. Upadacitinib is a selective and reversible JAK inhibitor. Upadacitinib showed a stronger inhibitory effect on JAK1 than JAK2, JAK3 and TYK2 in the experiments of cell and enzyme activity. 

4. On May 22, FDA's website revealed that Hansi Aitai's HX009 had been approved for clinical treatment. This is a phase I b/II clinical research to be carried out in America, aiming at evaluating the efficacy of HX009 in patients with recurrent/refractory lymphoma after failure of standard treatment. HX009 is a bispecific PD-1xCD47 antibody developed by Hansi Aitai, and its early phase I clinincal trial has been carried out in Australia and China. 

5. On May 25, FDA's website revealed that Insilicon Medicine's ISM3091 had been approved for clinical treatment, and phase I clinical trial will be carried out in patients with solid tumors. ISM3091 is an oral small molecule inhibitor with high selectivity, targeting the novel "synthetic lethal" target, USP1, to regulate the DNA damage and repair. 

6. On May 31, FDA's website revealed that sNDA of AstraZeneca's PARP inhibitor Olaparib (brand name: Lynparza) had been approved by FDA for the first-line treatment of adult mCRPC patients with BRCAm in combination with abiraterone and prednisone or prednisolone. The indication has been approved by the EU in December 2022. 

EMA 

1. On May 10, EMA official website revealed that the new indication of AstraZeneca's ravulizumab (brand name: Ultomiris) had been approved for marketing for treating NMOSD with AQP4 antibody positive (Ab+). Ravulizumab became the world's first long-acting C5 complement inhibitor approved for treating the NMOSD. 

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.