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

NMPA 

Listing Approval:

1.   On August 30, according to the official website of CDE, Xuanzhu Biopharm's Class 1 new drug piroctinib tablets were declared for marketing, which is intended to be used in combination with fulvestrant for the treatment of HR+/HER2- advanced breast cancer that has progressed after previous endocrine therapy. Piroctinib is a selective CDK4/6 inhibitor independently developed by Xuanzhu Biologics.

2.   On August 30, according to the official website of CDE, BeiGene's PD-1 monoclonal antibody tislelizumab injection was declared for marketing for the 13th indication. Tislelizumab has been approved for 11 indications in China, covering non-small cell lung cancer (NSCLC), classical Hodgkin lymphoma, urothelial carcinoma, hepatocellular carcinoma, esophageal squamous cell carcinoma (ESCC), nasopharyngeal carcinoma, gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, etc.

3.   On August 31, according to the official website of CDE, Qilu Pharmaceutical's Class 3 generic drug enzalutamide tablets were declared for marketing, intended for prostate cancer, and Qilu also became the first pharmaceutical company to report production. Enzalutamide is an androgen receptor inhibitor jointly developed by Astellas and Medivation, and was approved for marketing in China in November 2019.

4.   On August 31, according to the official website of the NMPA, Chia Tai Tianqing's recombinant human coagulation factor VIII. for injection (trade name: Anhengji) was approved for marketing for the prevention of bleeding in patients aged 12 years and above with hemophilia A (congenital coagulation factor VIII deficiency). ANHENGJI uses human cells HEK293 for production, which will not cause hypersensitivity reactions caused by non-human proteins.

5.   On September 1, according to the official website of the NMPA, AstraZeneca's aclotinib capsule (trade name: Calquence) was approved for a new indication, and the monotherapy is suitable for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior treatment. Acotinib is a next-generation selective BTK inhibitor.

6.   On September 1, Zai Lab's magetuximab injection was approved for marketing on the official website of the NMPA for the treatment of patients with metastatic HER2-positive breast cancer in the third line and above. Magituximab is an Fc-optimized monoclonal antibody developed by MacroGenics for the purpose of human epidermal growth factor receptor 2 (HER2).

7.   On September 1, according to the official website of the NMPA, Zhifei's 23-valent pneumococcal polysaccharide vaccine was approved for marketing for the treatment of children and adults aged 2 years and above to prevent infectious diseases caused by pneumococcus. Pneumococcus is an important pathogen that causes community-acquired pneumonia in people of all age groups.

8.   On September 1, according to the official website of CDE, Cynogen's Class 3 generic drug bumetanide injection was declared for marketing, and its main function is diuretic. Sajing Biopharma is the sixth pharmaceutical company to apply for the listing of Class 3 generic drugs. Bumetanide is a derivative of m-aminobenzene sulfonamide, developed by Validus Pharms, and no imported drugs have been approved in China, nor have Class 3 generic drugs been approved.

9.   On September 5, according to the official website of CDE, Hainan SinoMab BioScience Class 1 therapeutic biological product sucilimab injection was declared for marketing, which is predicted to be used for the treatment of rheumatoid arthritis (RA). Sucilimab is a monoclonal antibody targeting the unique B-cell target CD22, and it is also the first CD22 monoclonal antibody to be applied for marketing in China.

10.  On September 5, according to the official website of CDE, Merck & Co., Ltd. 3.1 class prevention biological product nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) was declared for marketing for a new indication. The vaccine is a 9-valent vaccine made of virus-like particles (VLPs) using recombinant Saccharomyces cerevisiae CANADE3C-5 (strain 1895) expressing recombinant human papillomavirus (HPV) L1 proteins 6, 11, 16, 18, 31, 33, 45, 52 and 58, respectively, purified and supplemented with aluminum adjuvant.

11.  On September 5, according to the official website of CDE, SHR-A1811 for injection of Hengrui Pharmaceutical's Class 1 therapeutic biological products is intended to be included in the breakthrough therapy variety for the treatment of HER2-positive advanced colorectal cancer. SHR-A1811 is a HER2-targeting antibody-drug conjugate (ADC) that has been granted Breakthrough Therapy Designation three times for the treatment of HER2-positive recurrent or metastatic breast cancer, HER2-low recurrent or metastatic breast cancer, and HER2-mutated advanced non-small cell lung cancer.

12.  On September 6, according to the official website of CDE, Yingli Pharma's new indication of linpulisab tablets, a class 1 chemical drug, was declared for marketing, which is intended to be used for the treatment of patients with relapsed and/or refractory peripheral T-cell lymphoma (R/R PTCL), which is the second indication of Linplixab to be declared for marketing. It is a highly selective small molecule inhibitor targeting PI3Kδ that has been conditionally approved for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.

13.  On September 6, according to the official website of the NMPA, Narusolimab Injection (JMT103, trade name: Jinlisheng), a Class 1 therapeutic biological product of JMT Biological, a subsidiary of CSPC Pharmaceutical Group, was conditionally approved for marketing for the treatment of adult patients with giant cell tumor of bone who are inoperable or whose resection may lead to severe functional impairment. Nalusolimab is a recombinant fully human antinuclear factor-κB receptor activating factor ligand (RANKL) monoclonal antibody.

14.  On September 6, according to the official website of CDE, Amgen's Class 1 therapeutic biological product AMG133 was declared for clinical trial, which is intended to be used for the treatment of overweight or obesity. AMG133 is a first-in-class bispecific antibody peptide conjugate that requires only 1 subcutaneous injection every 4 weeks for obesity indications.

15.  On September 6, according to the official website of CDE, Zhongshuai Pharmaceutical's dexmethylphenidate hydrochloride sustained-release capsule is intended to be included in the priority review for the treatment of attention deficit hyperactivity disorder (ADHD, commonly known as ADHD). Dexmethylphenidate hydrochloride extended-release capsules, a racemic D-threonist enantiomer of methylphenidate, also work by inhibiting the reuptake of norepinephrine and dopamine.

16.  On September 7, according to the official website of the NMPA, the new indication of Luye Pharma's Class 2.2 chemical drug Goserelin Acetate Sustained-Release Microspheres for Injection (trade name: Baitowei) was approved for the use of breast cancer patients in premenopausal and perimenopausal women who can be treated with hormone. The drug is the world's first and currently the only approved goserelin microsphere formulation.

17.  On September 7, according to the official website of CDE, the new indication of Remegen Biologics Class 1 therapeutic biological product tetanercept for injection (RC18, trade name: Taiai) was declared for marketing, which is predicted to be used for the treatment of rheumatoid arthritis (RA). Tetanercept is a novel recombinant fusion protein (TACI-Fc) of the Fc moiety of TACI and human immunoglobulin G (IgG) that inhibits both BLyS and APRIL.

18.  On September 7, according to the official website of CDE, HZ-A-018 capsules, a Class 1 chemical drug of Hezheng Pharmaceutical, are proposed to be included in the breakthrough therapy category for the treatment of relapsed or refractory primary central nervous system lymphoma. HZ-A-018 is an oral small molecule BTK inhibitor with high selectivity and high blood-brain barrier permeability.

19.  September 11, According to the official website of CDE, Kelun Pharmaceutical's holding subsidiary Kelun Botai's cetuximab biosimilar A140 injection (trade name: Dataila) has been declared for marketing, and the proposed indications are: 1) for the treatment of RAS wild-type metastatic colorectal cancer, including in combination with FOLFOX or FOLFIRI chemotherapy regimens for first-line treatment, and in combination with irinotecan for patients who have failed to receive irinotecan-containing therapy;2) for the treatment of head and neck squamous cell carcinoma, including in combination with platinum-based and fluorouracil chemotherapy for the first-line treatment of recurrence andand/or metastatic disease, and in combination with radiotherapy for the treatment of locally advanced disease.

20.  On September 12, according to the official website of CDE, Salubris' new class 2.3 drug alisartan cil indapamide sustained-release tablets were declared for marketing, which is intended to be used for the treatment of essential hypertension. Alisartan cilexetil indapamide extended-release tablets are ARB/diuretic compound sustained-release preparations, one of the components is alisartan ciloxil is an angiotensin II receptor antagonist, and the other ingredient indapamide is a sulfonamide diuretic, which has diuretic and calcium channel blocking effects.

21.  On September 12, according to the official website of CDE, Livzon Pharmaceutical's Class 2.2 new drug aripiprazole microspheres for injection were declared for marketing for the treatment of adult schizophrenia. Aripiprazole Microspheres for Injection is a long-acting sustained-release preparation independently developed by Livzon Microspheres, which can be administered once a month compared with ordinary dosage forms, which can reduce the number of dosing times and improve medication compliance.

22.  On September 13, according to the official website of CDE, Haisco Pharmaceutical's new indication for Class 1 new drug HSK16149 capsule was declared for marketing, and the predicted indication was postherpetic neuralgia. The first indication to be declared for marketing in HSK16149 is diabetic peripheral neuralgia. HSK16149 capsules are oral GABA analogues that can bind to α2-δ accessory proteins to exert analgesic effects.

23.  On September 13, according to the official website of CDE, Johnson & Johnson's 3.1 therapeutic biological product terituzumab injection is intended to be included in the priority review, and is intended to be used as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least three prior treatments (including a proteasome inhibitor, an immunomodulator and an anti-CD38 monoclonal antibody). Teritumab is a "first-in-class" bispecific antibody therapy targeting BCMA and CD3.

24.  On September 14, according to the official website of CDE, the class 1 new drug golixitinib capsule of Dizhe Pharma was declared for marketing for the treatment of relapsed and refractory peripheral T-cell lymphoma (r/r PTCL). Golixitinib is the world's first and only highly selective JAK1 inhibitor in the NDA application stage in the field of T-cell lymphoma, and is conducting pivotal clinical trials in China, the United States, South Korea and Australia.

25.  On September 14, according to the official website of CDE, Marinus Pharmaceuticals and Tenacia Biotechnology 5.1 class chemical drug plus nexoxone oral suspension were declared for marketing for the treatment of seizures in patients with cyclin-dependent kinase 5 (CDKL5) deficiency (CDD) aged 2 years and older. Ganxolone is a positive sterosteric modulator targeting GABAA receptors.

26.  On September 15, according to the official website of the NMPA, the irinotecan hydrochloride liposome injection of CSPC Ouyi Pharmaceutical was approved for marketing for the treatment of pancreatic cancer, which is the first generic version of irinotecan hydrochloride liposome injection approved for marketing in China. Liposomes, as a new class of drug carriers, have the characteristics of active structural effect of lactone ring protection, passive targeting, and slow release of drugs.

27.  On September 15, according to the official website of the NMPA, the new indication of Eli Lilly's dulaglutide injection (trade name: Duyida) was approved, and it is predicted to be dulaglutide combined with insulin for the treatment of adult type 2 diabetes. Dulaglutide is a long-acting human GLP-1 receptor agonist.

28.  On September 19, according to the official website of the NMPA, Organon's ezetimibe atorvastatin calcium tablets (I)/(II.) (trade name: Iferto) were approved for marketing for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). Ezetimibe atorvastatin calcium tablets are fixed combinations of ezetimibe and atorvastatin, both of which have been widely used in clinical practice to reduce low LDL-C levels.

29.  On September 19, according to the official website of CDE, Qilu Pharmaceutical's Class 4 generic drug apalutamide tablets were declared for listing, which is the first generic drug of apalutamide to be declared for marketing in China. Apalutamide is a next-generation oral androgen receptor inhibitor developed by Johnson & Johnson, and the compound patent expires in 2027.

30.  On September 19, according to the official website of CDE, Astellas' Enzalutamide Soft Capsule (trade name: Xtandi/Ancortan) was declared for marketing for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). Enzalutamide is a specific androgen receptor (AR) inhibitor approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC).

31.  On September 19, according to the official website of the CDE, Genting Xinyao's combination packaging of cefepime hydrochloride for injection/taniboramidan hydrochloride is proposed to be included in the priority review for the treatment of complicated urinary tract infections (cUTIs) in adults, including pyelonephritis. Cefepime/tanibor for injection is a β-lactam/β-lactamase inhibitor (BL/BLI) antimicrobial drug.

32.  On September 19, according to the official website of the CDE, Pfizer's abuxitinib tablets are intended to be included in the priority review for adolescent patients aged 12 years and older with refractory, moderate to severe atopic dermatitis who have not responded well to other systemic therapies (such as hormones or biologics) or are not suitable for the above treatments. Abuxitinib is an oral JAK1 inhibitor approved for the treatment of adults with refractory, moderate-to-severe atopic dermatitis.

33.  On September 21, according to the official website of the CDE, CANbridge's clomaxibat oral solution is proposed to be included in the priority review for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged 2 months and above. Lomaxibat oral solution is a virtually non-absorbable ileal bile acid transporter (IBAT) inhibitor approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

34.  On September 21, according to the official website of CDE, AstraZeneca's osimertinib mesylate tablets were declared for marketing for a new indication. Osimertinib is an irreversible third-representative epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastasis.

35.  On September 21, according to the official website of the NMPA, Novartis' erenumab (trade name: Erenumab) injection was approved for marketing, which only needs to be done once a month for the prevention of migraine in adults. Erenumab is a fully human monoclonal antibody co-developed by Amgen and Novartis for the prevention of migraine by blocking calcitonin gene-related peptide (CGRP) activity.

36.  On September 22, according to the official website of the NMPA, Sanofi's dupilumab (trade name: Dupixent) was approved for the new indication of prurigo nodosum in adults. This is also the second indication approved for dupilumab in China. Dupilumab is an anti-IL-4/IL-13 monoclonal antibody jointly developed by Sanofi and Regeneron.

37.  On September 22, according to the official website of the NMPA, Henlius' serplulimab (trade name: Hansizhuang) was approved for the new indication of combining chemotherapy for the first-line treatment of patients with locally advanced/metastatic esophageal squamous cell carcinoma (ESCC). This is also the fourth indication approved for serplulimab in China. Serplulimab is a recombinant humanized anti-PD-1 monoclonal antibody.

38.  On September 27, according to the official website of the NMPA, Eli Lilly and Company's insulin glargine injection (Youmuan) was approved for marketing for type 1 and type 2 diabetes in adults who need insulin treatment, and type 1 diabetes in adolescents and children aged 6 years and older. Insulin glargine injection is an insulin biosimilar.

39.  On September 26, according to the official website of CDE, PEGBIO's vepanatide injection was declared for marketing to improve blood sugar control in adult patients with type 2 diabetes. Vepanatide injection is a new generation of long-acting GLP-1 receptor agonists independently developed by Paige Biotech, which can be administered once a week.

40.  On September 27, according to the official website of CDE, Hengrui Pharmaceutical's new indication of proline hengagliflozin tablets was declared for marketing, and it is speculated that the indication is to combine metformin and repagliptin phosphate to improve blood sugar control in patients with type 2 diabetes. Hengpagliflozin proline tablets are sodium-glucose cotransporter 2 (SGLT2) inhibitors, which were first approved for marketing in December 2021 for improving blood sugar control in adults with type 2 diabetes.

41.  On September 27, according to the official website of CDE, Innogen Pharmaceutical's Class 1 new drug supaglutide injection was declared for marketing for the treatment of type 2 diabetes. Supaglutide is a new generation of human, long-acting GLP-1 receptor agonists, which can not only promote insulin secretion, but also promote β cell regeneration and improve the quality of β cells.

42.  On September 27, according to the official website of CDE, Kedi Group's minocycline hydrochloride foam (CU-10201) was declared for marketing for the treatment of non-nodular moderate to severe acne vulgaris in children and adults aged 9 years and above. Minocycline Hydrochloride Foam is a topical 4% minocycline foam, a tetracycline antibiotic used to treat bacterial infections and acne vulgaris, which inhibits the formation of bacterial peptide chains by blocking amino acids from entering ribosomes.

43.  On September 28, according to the official website of CDE, GileadS's lenacapavir injection (lenacapavir) was declared for marketing for the treatment of HIV infection. Lenacapavir is a first-in-class long-acting HIV capsid inhibitor that has been marketed in the United States, the European Union, Japan and other countries, and is the only approved drug for HIV treatment administered twice a year.

FDA

Listing Approval:

1.   On August 28, according to the FDA's official website, BMS's new indication of luspatercept (trade name: Reblozyl) was approved adult patients with very low- to intermediate-risk myelodysplastic syndrome (MDS) has not received erythropoiesis agents (ESA-naïve) and may require regular red blood cell (RBC) transfusions. Rottercept is a world-first erythrocyte maturation agent used to regulate late erythrocyte maturation and increase hemoglobin levels.

2.   On August 28, according to the official website of the FDA, AbbVie's risenkimab (1200mg intravenous [IV] [induction dose] and 180mg and 360mg subcutaneous injection [maintenance dose], trade name: Skyrizi) was declared for marketing for the treatment of adult patients with moderately to severely active ulcerative colitis. Rexintizumab is an interleukin-23 (IL-23) inhibitor.

3.   On August 30, according to the FDA's official website, Outlook Therapeutics' marketing application for bevacizumab (ONS-5010) for the treatment of wet age-related macular degeneration (wAMD) received a CRL issued by the FDA. The FDA said in the CRL that it could not approve its marketing within the current review timeframe. The original bevacizumab (Avastin) is an anti-VEGF-A monoclonal antibody developed by Roche, which is currently only suitable for cancer patients.

4.   On September 5, according to the FDA's official website, Immunofoco's IMC008 was granted orphan drug designation for the treatment of pancreatic cancer patients. Previously, the product was granted orphan drug designation by the FDA for the treatment of gastric cancer. IMC008 is a new generation of autologous CAR-T product developed based on SNR technology platform.

5.   On September 6, according to the official website of the FDA, Roche's Genentech's crovalimab was declared for marketing, which is intended to be used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). If approved, it will be the first once-monthly subcutaneous formulation for PNH that can be self-administered by patients. Corolimab is a new type of circulating monoclonal antibody targeting complement C5.

6.   On September 6, according to the FDA's official website, Senlang Biotech's SENL101 autologous T cell injection was granted orphan drug designation for the treatment of adult relapsed or refractory T-lymphoblastic lymphoma/leukemia (T-LBL/ALL). SENL101 Autologous T Cell Injection is a CD7 nanobody-based CAR-T cell product, which mainly targets lymphohematopoietic malignant tumors originating from CD7-positive T cells.

7.   On September 11, according to the FDA's official website, Verona Pharma ensifentrine was declared for marketing for the maintenance treatment of chronic obstructive pulmonary disease (COPD), and the PDUFA date was set for June 26, 2024. If approved, ensefentine is expected to become a new mechanism drug approved in the field of COPD for more than 10 years. Encefentine is an inhaled phosphodiesterase 3/4 (PDE3/4) inhibitor developed by Verona Pharma. UniRay has rights and interests in China.

8.   On September 12, according to the FDA's official website, Arcutis' roflumilast (0.15%) cream was declared for marketing for the treatment of mild to moderate atopic dermatitis (AD) in people aged 6 years and older. Roflumilast cream is a modified new drug developed by Arcutis using HydroARQ technology that is rapidly absorbed without disrupting the skin barrier.

9.   On September 13, Alnylam Pharmaceuticals announced the FDA's Advisory Committee on Cardiovascular and Renal Drugs (CRDAC) on its RNAi therapeutic, patisiran(Trade Name: Onpattro) Supplemental New Drug Application (sNDA) Discussion Results. With a positive vote of 9:3, CRDAC believes that the benefits of patisiran for the treatment of transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) outweigh the risks. The PDUFA date for this sNDA is October 8, 2023.

10.  On September 20, Merck announced that the Supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda, Drug K), a PD-1 monoclonal antibody, has been granted priority review by the FDA for the treatment of patients with newly diagnosed high-risk locally advanced cervical cancer in combination with concurrent chemoradiotherapy. PDUFA is dated January 20, 2024. If approved, drug K would be the first immunotherapy in this population.

11.  On September 25,  ABM Therapeutics announced that ABM-1310 was granted Fast Track Designation by the FDA for the treatment of glioblastoma (GBM) harboring BRAF V600E mutations. ABM-1310 is a next-generation BRAF inhibitor.

12.  On September 26, Regeneron announced that the FDA has accepted and granted Priority Review status to dupilumab (Dupixent) for supplemental biologics license (sBLA) for patients aged 1 to 11 years with EoE (eosinophilic esophagitis) with a PDUFA date of January 31, 2024.