Drug Marketing in China and Worldwide (October)(2023)

NMPA

Lisiting Approvals:

1.   On October 12, according to the official website of the NMPA, Betta Pharmaceutical's Class 1 chemical drug befatinib mesylate capsule (trade name: Semena) was approved for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) replacement mutations. Befatinib is the third representative of the cutaneous growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

2.   On October 9, according to the official website of CDE, Bebetter Med's Class 1 new drug biristalat for injection (BEBT-908 for injection) was declared for marketing, and the presumed indication is adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL) who have received at least two prior systemic therapies. Birisristal for injection is a first-in-class HDAC/PI3K dual-target anti-cancer drug introduced by Bibet Biopharma from Curis in 2012.

3.   On October 10, according to the official website of CDE, CSPC Pharmaceutical Group's Class 4 generic Ilaprazole enteric-coated tablets were declared for marketing, which is intended to be used for duodenal ulcer and reflux esophagitis. This is the first generic drug of ilaprazole enteric-coated tablets to be declared for marketing. The original product of ilaprazole enteric-coated tablets was developed by Livzon Group, and the terminal sales of the hospital in 2022 will be about 1.2 billion yuan.

4.   On October 11, according to the official website of CDE, Karyopharm Therapeutics and Antengene's selinexor tablets were declared for marketing for the treatment of relapsed/refractory diffuse large B-cell lymphoma. Selinexor is an orally selective nuclear export protein (XPO1) inhibitor.

5.   On October 12, according to the official website of CDE, the 3 generic drugs niergoline tablets jointly developed by Jiangxi Dasheng Medicine and Visum Pharma were declared for marketing, and the predicted indication was cerebrovascular-related diseases. This is the seventh domestic nicergoline tablets to be declared for marketing, after Kunshan Rotam Reddy's Pharmaceutical's nicergoline tablets passed the consistency evaluation and was the first in China to pass the evaluation.

6.   On October 17, according to the official website of the NMPA, AstraZeneca's eculizumab (Soliris) was approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Eculizumab is the world's first approved complement inhibitor that inhibits the uncontrolled activation of the immune system by inhibiting terminal complement.

7.   On October 18, according to the official website of the NMPA, Macitentan tablets from East China, Nanjing Chia Tai Tianqing and Puji Biotech were approved for marketing, and the three companies jointly won the first generic of macitentan tablets. Macitentan is an endothelin receptor antagonist, which was first developed by Actelion Pharmaceuticals and approved by the FDA in 2013, and is the first oral formulation approved for pulmonary hypertension.

8.   On October 19, according to the official website of the NMPA, Bristol-Myers Squibb's (BMS) deuterated colacitinib tablets were approved for marketing for the treatment of moderate to severe plaque psoriasis. This product is also the first TYK2 inhibitor approved for marketing in China. In addition to psoriasis, deuterated colecitinib has been developed to treat a variety of immune diseases such as psoriatic arthritis, scalp psoriasis, systemic lupus erythematosus, and inflammatory bowel disease.

9.   On October 19, according to the official website of the NMPA, Pfizer's ritlecitinib capsule (trade name: Lefunuo) was approved for marketing for adolescents aged 12 years and older and adults with severe alopecia areata who are suitable for systemic treatment. Litexitinib tosylate is a kinase inhibitor that irreversibly inhibits the JAK3 and tyrosine kinase families.

10.  On October 17, according to the official website of CDE, Xuanzhu Bio's Class 1 new drug piroctinib tablets were declared for marketing, and pirobusinib is used as a single drug for adult breast cancer patients with locally advanced or metastatic adult breast cancer who have undergone disease progression after receiving two or more endocrine therapies and one chemotherapy in the previous metastatic stage. Piroctinib is an oral small molecule cell cycle-dependent kinase 4/6 (CDK4/6) inhibitor independently developed by Xuanzhu Biopharma.

11.  On October 17, according to the official website of CDE, Hisco Class 1 new drug HSK21542 injection was declared for marketing, which is predicted to be used for postoperative analgesia. HSK21542 is a selective agonist of the peripheral kappa opioid receptor developed by HiSilicon with high selectivity and affinity

12.  On October 18, according to the official website of CDE, BeiGene's PD-1 monoclonal antibody tislelizumab was declared for marketing in combination with etoposide and platinum-based chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This is the 14th indication NDA for tislelizumab in China.

13.  On October 19, according to the official website of CDE, Kowa Company's 5.1 class new drug pemafibrate tablets were declared for marketing, which is predicted to be used for the treatment of dyslipidemia. Pemafirate tablets are a novel peroxisome proliferator-activated receptor (PPAR) α agonist that has previously been approved in Japan for the treatment of hyperlipidemia (including familial hyperlipidemia).

14.  On October 16, according to the official website of the CDE, Eli Lilly's pirtobrutinib tablets are to be included in the priority review for the indication of monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received BTK inhibitor therapy. Pirtobrutinib is a highly selective, non-covalent (reversible) BTK inhibitor with a novel binding mechanism.

15.  On October 16, according to the official website of CDE, Changchun GeneScience Pharmaceutical's polyethylene glycol recombinant human growth hormone injection (trade name: Kinsaizeng) is proposed to be included in the priority review, with a specification of 27IU/4.5mg/0.5ml/bottle, for the treatment of children with growth retardation caused by endogenous growth hormone deficiency, as well as idiopathic short stature (ISS), Growth failure in children caused by congenital ovarian hypoplasia syndrome (Turner syndrome).

16.  On October 17, according to the official website of CDE, the enteric-coated capsule of Purun’ao Biotechnology, a subsidiary of Avistone Pharmaceuticals, is proposed to be included in the priority review for the treatment of adult patients with isocitrate dehydrogenase (IDH)-mutant WHO grade 4 astrocytoma with PTPRZ1-MET (ZM) fusion gene or glioblastoma (GBM) with a history of lower grade who have relapsed or are intolerant after radiotherapy and temozolomide (TMZ) therapy. Britinib is a small molecule selective MET inhibitor.

17.  On October 24, according to the official website of the NMPA, Johnson & Johnson's rilpivirine injection (trade name: Rekambys) was approved for marketing for the treatment of HIV-1 infection. Previously, in December 2012, rilpivirine tablets were launched in China. Rilpivirine injection is a long-acting injectable suspension that was approved by the FDA in January 2021 in combination with captegravir injection in selected HIV-1-infected adult patients, under the trade name Cabenuva.

18.  On October 27, according to the official website of the NMPA, two new indications of AbbVie's upadacitinib extended-release tablets (trade name: Ruifu) were approved for the treatment of poor response to non-steroidal anti-inflammatory drugs (NSAIDs) and objective signs of inflammation (manifested by elevated C-reactive protein ICRPT and/ or MRI abnormal) and for the treatment of adult patients with active ankylosing spondylitis (AS) who have a poor response to or intolerance to one or more TNF inhibitors.

19.  On October 24, according to the official website of CDE, the new indication of beritinib enteric-coated capsules, a class 1 new drug of Purun’ao Biotechnology, a wholly-owned subsidiary of Avistone Pharmaceuticals, was declared for marketing, which is intended for the treatment of adult patients with IDH-mutant WHO grade 4 astrocytoma with PTPRZ1-MET fusion gene who have relapsed or are intolerant after radiotherapy and temozolomide treatment or glioblastoma (GBM) with a previous history of lower grade. Britinib is a small molecule selective MET inhibitor.

20.  On October 25, according to the official website of CDE, the somituximab injection (IMGN853, HDM2002) jointly developed by Huadong Medicine, a wholly-owned subsidiary of Huadong Medicine, and ImmunoGen was declared for marketing for the treatment of adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have received 1-3 lines of systemic therapy with folic acid receptor α (FRα)-positive. Somituximab is a first-in-class ADC drug targeting FRα.

21.  On October 26, according to the official website of CDE, Johnson & Johnson's amivantamab injection was declared for marketing. Previously, the therapy was approved in the U.S. for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, and was granted Breakthrough Therapy Designation by the CDE for the treatment of specific NSCLC. Avatomab is an investigational, fully humanized bispecific antibody targeting EGFR and MET.

22.  On October 26, the CDE website showed that the MBS314 injection jointly developed by Mabworks and Kyinno Biotechnology was declared for clinical trial. This product belongs to CD3/GPRC5D/BCMA triclonal antibody. Preclinical trials have shown that MBS314 has a better tumor killing effect than CD3/BCMA bispecific antibody (BMS) and CD3/GPRC5D bispecific antibody (Talquetamab, Johnson & Johnson).

23.  On October 24, according to the official website of CDE, GFH925 tablets (IBI351) jointly developed by Innovent Biologics and GenFleet Therapeutics are to be reviewed on a priority basis for KRASG12C-mutant advanced non-small cell lung cancer (NSCLC) that has received at least one systemic therapy. GFH925 is a specific covalent irreversible KRASG12C inhibitor.

FDA

Listing Approvals:

1.   On October 6, according to the official website of the FDA, Indian SunPharmaceuticals company deuteruxolitinib (CTP-543) was declared for marketing, which is intended to be used for the treatment of moderate to severe alopeciaareata (AA). Deuterusolitinib is an oral JAK1/JAK2 inhibitor developed by ConcertPharmaceuticals. In March 2023, Sun Pharma acquired all rights to the product.

2.   On October 9, according to the official website of the FDA, Humanwell PharmaceuticalUS, a subsidiary of Humanwell Pharmaceutical, has been tentatively approved for the treatment of neuralgia after herpes zoster infection. Gralise, the original drug of Gabapentin tablets, belongs to Almatica. At present, in addition to Almatica, Teva, Incepta, PAR, and Zydus have been given tentative approval numbers.

3.   On October 9, according to the official website of the FDA, Luye Pharma's paliperidone palmitate sustained-release suspension injection (LY03010) was declared for marketing, which is intended to be used for the treatment of schizophrenia and schizoaffective disorder. LY03010 is a long-acting injection of paliperidone, administered once a month, and is expected to be the first long-acting injection of paliperidone palmitate manufactured by a Chinese company approved in the United States. At present, LY03010 is in the stage of listing review in China.

4.   On October 16, according to the FDA's official website, Merck's pembrolizumab (Keytruda, K) was approved for the perioperative treatment of resectable (tumor ≥ 4cm or node-positive) non-small cell lung cancer (NSCLC). Pembrolizumab (Keytruda, K) is a PD-1 monoclonal antibody.

5.   On October 17, according to the official website of the FDA, UCB's zilucoplan (trade name: Zilbrysq) was approved for marketing for the treatment of adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) antibody. zilucoplan is the first complement C5 inhibitor approved by the FDA for self-administered subcutaneously once daily for gMG.

6.   On October 18, according to the FDA's official website, Zhimeng Biopharma's CB03 obtained orphan drug designation for the treatment of patients with amyotrophic lateral sclerosis (also known as "ALS"). CB03 is a KCNQ2/3 selective opener, which is expected to provide an important option for patients with ALS and other CNS diseases to obtain new drug treatments.

7.   On October 18, according to the official website of the FDA, the HB0034 injection of Huaota Biopharm, a subsidiary of Huahai Pharmaceutical, obtained orphan drug designation for the treatment of generalized pustular psoriasis (GPP). HB0034 is a humanized IgG1 (immunoglobulin G1) monoclonal antibody targeting IL-36R (interleukin-36 receptor), which can specifically bind to IL-36R and block IL-36 inflammatory pathway signaling.

8.   On October 24, according to the official website of the FDA, Servier's ivosidenib (trade name: Tibsovo) was approved for a new indication for the treatment of IDH1-mutated relapsed or refractory myelodysplastic syndrome (R/RMDS). Ivosidenib became the first targeted drug approved for the treatment of IDH1-mutant MDS, which is the fourth indication approved for ivosidenib in the United States.

9.   On October 24, according to the FDA's official website, Milestone's etripamil nasal spray was declared for marketing for the treatment of paroxysmal supraventricular tachycardia (PSVT). Etripamil, a novel calcium channel blocker and a nasal spray that can be self-administered by patients at home, has the potential to change the treatment paradigm for PSVT.

10.  On October 26, according to the FDA's official website, Eli Lilly's mirikizumab (trade name: Omvoh) was approved for marketing for the treatment of moderate to severe ulcerative colitis (UC) in adults. Mirikizumab also became the first IL-23 antibody approved for the treatment of UC. Mirikizumab is a monoclonal antibody targeting the IL-23p19 subunit for the indications currently being developed for ulcerative colitis, Crohn's disease, and plaque psoriasis.

11.  On October 27, according to the official website of the FDA, Roche's faricimab (trade name: Vabysmo) was approved for a new indication for the treatment of macular edema secondary to retinal vein occlusion (RVO). Farecimab is a bispecific monoclonal antibody developed by Roche targeting angiopoietin 2 (Ang2) and vascular endothelial growth factor A (VEGFA).