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

NMPA (National Medical Products Administration).

Listing Approval:

1.   On August 1, according to the official website of CDE, Astellas' Class 1 therapeutic biologics zotuximab for injection was applied for marketing for the first-line treatment of patients with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. This is the world's first CLDN18.2 monoclonal antibody.

2.   On August 1, according to the official website of CDE, Ivonescimab Injection (code: AK112), a Class 1 therapeutic biological product of Akeso, was declared for marketing for the treatment of EGFR-TKI-resistant non-small cell lung cancer (NSCLC). AK112 is the world's first PD-1/VEGF bispecific antibody independently developed by Akeso to enter clinical studies.

3.   On August 1, according to the official website of CDE, Jacobio's Grerese(JAB-21822) is intended to be included in a breakthrough therapy for the treatment of adult patients with locally advanced or metastatic pancreatic cancer with KRASG12C mutations who have disease progression after prior treatment with gemcitabine plus nab-paclitaxel or FOLFIRINOX. JAB-21822 is a KRASG12C inhibitor independently developed by Jacobio.

4.   On August 2, according to the official website of CDE, the new indication of FibroGen Class 1 chemical drug Roxadustat Capsules was declared for marketing, and it was speculated that the indication was anemia caused by chemotherapy. Roxadusta is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by Fabojin, which is the first HIF-PH inhibitor in the field of CKD anemia.

5.   On August 2, according to the official website of CDE, HEC Class 1 chemical drug Antaitavir phosphate capsules were declared for marketing for the treatment of chronic hepatitis C in adults. Antaitavir Hasophate is a hepatitis C virus (HCV) NS5A inhibitor that is structurally similar to Gilead's second-generation pan-genotype NS5A inhibitor vepatasvir (epclusa, Kyrgyzstan III).

6.   On August 2, according to the official website of CDE, Nanjing ChiaTai Tianqing's Class 4 chemical drug palbociclib tablets were declared for marketing for the treatment of breast cancer. Chia Tai Tianqing became the third pharmaceutical company to apply for generic drugs of palbociclib tablets after Qilu Pharmaceutical and CSPC Pharmaceutical Group. Palbociclib is a small molecule CDK4/6 inhibitor developed by Pfizer.

7.   On August 3, according to the official website of the NMPA, Qilu Pharmaceutical's Class 4 chemical drug fulvestrant injection was approved for marketing for the treatment of breast cancer. Fulvestrant is an estrogen receptor down-regulating agent (SERD) anti-breast cancer treatment drug, originally developed by AstraZeneca and approved for marketing in China in 2010.

8.   On August 3, the official website of the NMPA announced that the new indication of Pfizer's 5.1 class chemical drug cliborol ointment (trade name: sultanmine) was approved, which is speculated to be used in children and adults aged 3 months and above with atopic dermatitis. Cleborol is a small-molecule, non-hormonal, non-steroidal anti-inflammatory topical phosphodiesterase 4 (PDE-4) inhibitor developed by Anacor.

9.   On August 3, according to the official website of NMPA, Qilu Pharmaceutical's Class 4 chemical drug octreotide acetate microspheres for injection were approved for marketing for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, becoming the first generic version of octreotide acetate microspheres approved for marketing in China. The drug is a long-acting injection of the somatostatin analogue octreotide, which was originally developed by Novartis and only needs to be administered once a month, and the original drug entered China in 2003.

10.  On August 3, according to the official website of the NMPA, BioNova Pharma’s  Class 5.1 chemical drug besudil mesylate tablets, was approved for marketing for the treatment of graft-versus-host disease, becoming the first ROCK2 inhibitor approved for marketing in China. In November 2019, BrightAceuticals entered into an agreement with Kadmon, Inc. (acquired by Sanofi) to establish BKPharmaceuticals as a joint venture to advance the development and commercialization of besudil in China.

11.  On August 4, according to the official website of CDE, Shanghai Biologics, a wholly-owned subsidiary of Shanghai Pharmaceutical, has applied for clinical trial for the treatment of relapsed or refractory B lymphocytic tumors. B019 can express two independent chimeric antigen receptors on T cells, binding to CD19 or CD22 proteins expressed on the surface of B lymphocytes, respectively, without affecting each other, to exert anti-tumor effects.

12.  On August 10, according to the official website of the NMPA, Livzon Group's Class 4 generic Blonanserin Tablets were approved for marketing for the treatment of schizophrenia. This variety is the second generic drug of Bunanserin tablets in China, and the first one is from Shijiazhuang No. 4 Medicine. Blonanserin is a 5-HT2A receptor antagonist and dopamine D2 receptor antagonist, which was approved for marketing in China in February 2017 by Sumitomo Pharma and Almirall.

13.  On August 11, the official website of the NMPA showed that the HDM3001 jointly developed by Huadong Medicine and Qyuns Therapeutics was declared for listing. HDM3001 belong to the ustekinumab biosimilar. Ustekinumab is a monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23, originally developed by Johnson & Johnson and approved for marketing in China in November 2017, for adult patients with moderate to severe plaque psoriasis who have not responded to, contraindicated or cannot tolerate other systemic therapies such as cyclosporine, methotrexate or PUVA (psoralen and ultraviolet A).

14.  On August 12, according to the official website of CDE, Qilu Pharmaceutical's Class 1 chemical drug apalolimab tovolilimab injection was declared for marketing. This is its immunotherapy combination antibody QL1706 (PD-1 IgG4 antibody ipalolimab/CTLA-4 IgG1 antibody tovolilimab), which is in phase III clinical studies for multiple tumor diseases.

15.  On August 14, according to the official website of CDE, G1 Therapeutics/Simcere Pharmaceutical's new indication of trilaciclib hydrochloride for injection of Class 5.1 chemical drugs was declared for marketing. Trilaciclib is a CDK4/6 inhibitor developed by G1 and a first-in-class therapy in the indication of chemotherapy-induced myelosuppression. In July 2022, trilaciclib was conditionally approved for marketing by the NMPA.

16.  On August 15, according to the official website of CDE, HEC Pharmaceutical's Class 1 chemical drug Inprebuvir Tablets was declared for marketing for the treatment of chronic hepatitis C in adults. Inpresibuvir is an NS5Bpolymerase inhibitor. East Sunshine focuses on the field of anti-infection, and its R&D pipeline includes three new hepatitis C drugs, oseltamivir, emitasvir, ampetamivir and impresibusir, as well as two hepatitis B drug candidates, mofixidine and prexidine.

17.  On August 16, according to the official website of the NMPA, Innovent Biologics' Class 1 therapeutic biologics tolecimab injection (code: IBI306) was approved for marketing for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. Tolecimab became the first recombinant fully human anti-PCSK-9 monoclonal antibody approved for independent research and development in China.

18.  On August 17, according to the official website of the NMPA, the new indication of AstraZeneca's 2.4 class chemical drug dapagliflozin tablets (trade name: Forxiga) was approved for the treatment of heart failure (HFpEF) with preserved ejection fraction. Dapagliflozin tablets are SGLT-2 inhibitors approved for the treatment of patients with type 2 diabetes mellitus (T2D), HFrEF and chronic kidney disease (CKD). In addition, in countries such as the United States, the United Kingdom, Japan, and other countries, the indication for heart failure has been extended to patients with total ejection fraction.

19.  On August 17, according to the official website of CDE, Kelun Pharma's Class 4 chemical drug luturimbopag tablets were declared for marketing, which is the first generic drug of lutrobopag tablets to be declared for marketing in China. Lutrombopag is an oral, small molecule human thrombopoietin receptor agonist for the treatment of adult patients with chronic liver disease with thrombocytopenia who are scheduled for surgery, including diagnostic procedures. In June 2019, Eden Pharma obtained the exclusive license to introduce the drug in Greater China. In June 2023, lutrombopag was approved for marketing by the NMPA.

20.  On August 17, according to the official website of CDE, AstraZeneca's 5.1 class chemical drug CalabrutinibMaleate tablets (acotinib maleate tablets) were declared for marketing. Acotinib is a second-generation selective BTK inhibitor independently developed by AstraZeneca, and in August 2022, acotinib tablets were approved by the FDA for the first time for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

21.  On August 21, according to the official website of CDE, Eli Lilly's tirzepatide injection (trade name: Mounjaro) was declared for marketing for a new indication, which is intended to be used to improve the long-term weight management of adult obesity or overweight patients with at least one weight-related comorbidity on the basis of a low-calorie diet and increased exercise. Tirzepatide is a once-weekly injectable GIPR and GLP-1R agonist. In May 2022, Tirzepatide was first approved by the FDA for the treatment of type 2 diabetes.

22.  On August 22, according to the official website of CDE, the biosimilar of liraglutide injection, a Class 3.3 therapeutic biological product of Federal Pharmaceutical, was declared for marketing, which is intended to be used for the treatment of adult type 2 diabetes. The original drug of liraglutide was developed by Novo Nordisk and entered China in 2011 and was approved for blood sugar control in adults with type 2 diabetes (trade name: Novo Nordisk).

23.  On August 22, according to the official website of CDE, Hengrui's fluzoparib capsule was declared for marketing for a new indication, which is intended to be used for maintenance therapy after achieving complete remission or partial remission with first-line platinum-containing chemotherapy for patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Fluzoparib is a self-developed PARP inhibitor that was first approved for marketing in December 2020.

24.  On August 23, according to the official website of CDE, Akeso's erokimab injection (AK101) was declared for marketing, presumably for the treatment of moderate to severe psoriasis. Erokizumab is a monoclonal antibody targeting IL-12/IL-23, a second-generation autoimmune disease target, and the Phase III pivotal registrational clinical trial of eronkizumab for the treatment of moderate to severe psoriasis has met the primary endpoint.

25.  On August 23, according to the official website of the NMPA, Dizal Pharma’s Suvotinib tablets (trade name: Suvozhe) were approved for marketing for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on platinum-containing chemotherapy in the past, or who have not tolerated platinum-containing chemotherapy and have been confirmed to have epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Suvozer is a highly selective EGFR-targeted drug targeting multiple EGFR mutant subtypes.

26.  On August 24, according to the official website of the NMPA, F&S Pharmatech's sacubitril-valsartan sodium tablets (brand name: Yixintan) were approved for marketing for the treatment of heart failure. This is the first generic drug of sacubitril-valsartan sodium tablets declared in China, and it is also the first drug of this variety to be successfully approved for marketing through independent innovation in the global regulatory market to break through the original patent barriers. Sacubitril-valsartan sodium tablets were originally developed by Novartis, and the trade name is Noxinto.

27.  On August 24, according to the official website of the NMPA, Roche's tocilizumab injection (subcutaneous injection) monotherapy regimen was approved for marketing for the treatment of moderately to severely active rheumatoid arthritis (RA) in adultsPatients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) prior therapy, and an inadequate response to methotrexate (MTX) or intolerant MTX therapy. Tocilizumab is an anti-IL-6R recombinant humanized monoclonal antibody.

28.  On August 24, according to the official website of the NMPA, Hengrui Pharmaceutical's 2.2 class new drug dexmedetomidine hydrochloride nasal spray was approved for marketing for the treatment of preoperative sedation in children (such as general anesthesia in children), after the drug had been approved for preoperative sedation/anxiolytic in adults. Dexmedetomidine hydrochloride is a relatively selective α2-adrenergic receptor agonist, and the original product was jointly developed by Oricon Pharma and Abbott.

29.  On August 24, according to the official website of CDE, Hengrui's amaxitinib tablets (SHR0302) were declared for marketing for a new indication, intended for rheumatoid arthritis. SHR0302 is a highly selective JAK1 inhibitor independently developed by Hengrui Pharmaceutical, which belongs to the class 1 new drug, and in June 2023, Hengrui submitted the first marketing application for the treatment of moderate to severe atopic dermatitis in adults and adolescents over 12 years old.

30.  On August 25, according to the official website of CDE, Livzon Pharmaceutical's new indication of triptorelin acetate microspheres for injection was declared for marketing, which is intended to be used for the treatment of endometriosis. Triptorelin acetate microspheres for injection are once-monthly intramuscular gonadotropin-releasing hormone (GnRH) agonists approved in May 2023 for prostate cancer patients requiring androgen castration.

FDA

Listing Approvals:

1.   On July 31, according to the FDA's official website, GSK's PD-1 monoclonal antibody dostarlimab (trade name: Jemperli) was approved for a new indicationAfter combining carboplatin and paclitaxel, dostarlimab monotherapy was used to treat adult patients with primary advanced or recurrent endometrial cancer with mismatch repair deficiency (dMMR)/high microsatellite instability (MSI-H). Dostarlimab is the first first-line therapy in endometrial cancer in decades and the first immunotherapy approved for the first-line treatment of endometrial cancer.

2.   On August 1, according to the FDA's official website, Merck's sotatercept (code: MK-7962) submitted a biological product license application (BLA) for the treatment of pulmonary hypertension (PAH). Sotatercept is a first-in-class ACVR2A-Fc fusion protein developed by AcceleronPharma. In September 2021, Merck acquired AcceleronPharma for this product.

3.   On August 1, according to the FDA's official website, Merck's gefapixant submitted a new drug application (NDA) for the treatment of refractory chronic cough (RCC). Gefapixant is a P2X3 receptor antagonist developed by Afferent Pharmaceuticals (acquired by Merck & Co., Ltd.).

4.   On August 2, according to the official website of the FDA, Bichen Pharmaceutical's small molecule BRAF inhibitor ABM-1310 received orphan drug designation for the treatment of BRAFV600-mutated glioblastoma (GBM). ABM-1310 is an oral drug with high selectivity, high water solubility, and high blood-brain barrier permeability.

5.   On August 3, the official website of the FDA showed that TAIHOOncology, Servier (Servier).The new indication of trifluridine+tipiracil (trade name: Lonsurf) was approved for the treatment of patients with metastatic colorectal cancer (mCRC) in combination with VEGF antibody bevacizumab. The drug is an oral nucleoside antitumor drug consisting of the thymidine-based nucleoside analogue trifluridine and the thymidine phosphatase inhibitor tepyrimidine.

6.   On August 4, the FDA's official website showed that Mesoblast's biologics license application (BLA) for the treatment of pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) was rejected by the FDA. Remestemcel-L is an allogeneic derived mesenchymal stem cell therapy developed by Mesoblast.

7.   On August 7, the FDA's official website showed that the New Drug Application (NDA) for Glatiramer acetate (GA Depot, 40mg) for the treatment of relapsing multiple sclerosis was accepted by the FDA, and the PDUFA date was set for March 8, 2024. GA Depot is a long-acting injectable formulation developed by Viatris and Mapi Pharma based on glatiramer that reduces the frequency of injections from 3 per week to 1 per month.

8.   On August 9, according to the FDA's official website, Galera Therapeutics received a complete response letter (CRL) from Avasopasem (GC4419) for the NDA application for the treatment of severe oral mucositis (SOM) caused by radiation therapy in patients with head and neck cancer (HNC) who received standard of care. Since the data from the Phase III ROMAN study and the Phase II.b GT-201 study were insufficient to demonstrate the efficacy and safety of the drug in reducing severe oral mucositis in patients with head and neck cancer, additional clinical trial results need to be submitted. Avasopasem is a selective small molecule dismutase mimic.

9.   On August 10, according to the FDA's official website, Johnson & Johnson's Talquetamab (TALVEY) was approved for accelerated marketing for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior treatments, including proteasome inhibitors, immunomodulators and CD38 antibodies. Talquetamab is a first-in-class off-the-shelf bispecific T cell-binding antibody that targets both GPRC5D on MM cells and CD3 on T cells.

10.  On August 14, the FDA's official website showed that Revance Therapeutics' injectable Daxibotulinumtoxin A-lanm(trade name: Daxxify, code name: RT002) was approved for the treatment of cervical dystonia. In September 2022, Daxxify was first approved by the FDA for the treatment of moderate to severe frown lines (glabellar lines) in adults. The product is a next-generation neuromodulator containing a stable peptide formulation and highly purified botulinum toxin type A, in which Fosun Pharma has a stake in China.

11.  On August 15, the official website of the FDA showed that Servier's ivosidenib (trade name: TIBSOVO) is used for the treatment of relapsed or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutationsThe NDA for the new indication was granted priority review status. Ivosidenib is the first oral small molecule inhibitor to precisely target IDH1 mutations. In July 2018, the drug was first approved for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) harboring IDH1 mutations.

12.  On August 16, according to the FDA's official website, Ipsen's palovarotene was approved for marketing for the treatment of children (girls aged 8 years and older and boys aged 10 years and older) and adult patients with progressive muscular ossification (FOP). In 2019, Ipsen acquired Clementia for $1.3 billion.

13.  On August 16, the official website of the FDA showed that Yi Mufeng's IMC008 was granted orphan drug designation for the treatment of gastric cancer patients. IMC008 is a next-generation autologous CAR-T product developed based on the company's synthetic natural killer receptor (SNR) technology platform, which has demonstrated a good safety profile and clearance of heterogeneous tumors in animal tumor models.

14.  On August 21, according to the official website of the FDA, Pfizer's bivalent respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF, PF-06928316) was approved for marketing for a new indication to prevent RSV-related lower respiratory tract diseases (LRTD) in infants from birth to 6 months of age through active immunization of pregnant women, which is the first FDA-approved maternal vaccine to protect babies from LRTD caused by RSV and severe LRTD from birth to 6 months.

15.  On August 24, according to the FDA's official website, Sandoz's natalizumab biosimilar Tyruko was approved for marketing for the treatment of multiple sclerosis (MS) and Crohn's disease (CD). This is the first biosimilar approved for multiple sclerosis and the first natalizumab biosimilar. Tysabri, originally developed by Biogen, was first approved by the FDA in 2004.

16.  On August 28, according to the FDA's official website, a new indication for the treatment of 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.

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

18.  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.