Pharmaceutical News of August | PharmaSources.com: Approval

Sep. 3

Information on two proposed breakthrough therapies was publicized on the CDE website, separately YY-20394 tablets (linperlisib) of YL-Pharma and plinabulin concentrated solution for injection of BeyondSpring. Before this, as a next-generation highly selective PI3Kδ inhibitor, linperlisib received two Orphan Drug Designations issued by the FDA for follicular lymphoma and chronic lymphocytic leukemia indications. Plinabulin is a major product of BeyondSpring, with the indications in development including the prevention of chemotherapy-induced neutropenia (CIN) and non-small cell lung cancer (NSCLC) treatment.

Qilu Pharmaceutical’s new Class 4 generic drug: Afatinib Dimaleate Tablets was approved by the NMPA for marketing, making it the 2nd enterprise approved to market this product in China following Hansoh.

AstraZeneca’s marketing application for its antithrombotic drug: Ticagrelor Orodispersible Tablet was approved by the NMPA. Ticagrelor is one of the blockbuster varieties of AstraZeneca, for which AstraZeneca has separately developed tablets, dispersible tablets, and orally disintegrating tablets. Sales of AstraZeneca’s ticagrelor reached USD1.581 billion in 2019.

Sep. 2

Chiatai Tianqing’s marketing application for the Class 4 generic drug: Saxagliptin Tablets entered the administrative approval stage, which is expected to be approved soon to make the company the 2nd in receiving the marketing approval for this variety in China following Aosaikang.

A marketing application was filed for a new indication of Hengrui’s camrelizumab and planned to be included in priority review (the acceptance No. has not been released at the moment); this new indication, according to an earlier announcement of Hengrui, is for the first-line treatment of nasopharyngeal cancer with local recurrence or distant metastasis in combination with cisplatin and gemcitabine.

Innovent’s Adalimumab Injection was approved by the NMPA for marketing to treat autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis, and psoriasis, making it the 3rd Chinese enterprise approved to market adalimumab following Bio-Thera and Hisun Pharmaceutical.

Athenex announced that the U.S. FDA accepted the company’s filing of the NDA for oral paclitaxel and granted it a Priority Review designation, with the indication being metastatic breast cancer. The FDA is expected to reply before Feb. 28 next year. Furthermore, the FDA indicated that it was not currently planning to hold an advisory committee meeting to discuss the NDA.

Aug. 31

Huadong Medicine announced that Zhongmei Huadong’s ANDA for the oral solid formulation: Acarbose Tablets filed to the U.S. FDA was approved. It is the first Chinese acarbose formulation product that receives the U.S. FDA’s approval and also the first Chinese acarbose formulation product that possesses marketing authorization in China, the U.S., and Austria in the EU.

Aug. 27

RemeGen’s marketing application for the self-developed HER-2 ADC: Disitamab Vedotin for Injection was accepted by the NMPA for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) and was included in the priority review and approval procedure. It is the first Chinese-produced ADC applied for marketing.

Bayer filed a marketing application for its new heart failure drug: Vericiguat Tablets in China. Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator. It will become the first-in-class sGC stimulator for heart failure treatment if successfully marketed.

Qilu Pharmaceutical’s marketing application Tofacitinib Citrate Extended-Release Tablets according to a Class 3 generic drug was accepted by the CDE. As a JAK inhibitor developed by Pfizer, indications approved for tofacitinib worldwide include rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis.

Bayer announced that its radium-223 chloride [223Ra] injection was approved by the NMPA, which is an alpha particle-emitting radiotherapy drug used to treat patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases, without known visceral metastases.

Cassiopea announced that the U.S. FDA approved the marketing of Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. This innovative therapy is the first acne drug approved by the FDA with a new mechanism of action (MOA) in recent 40 years, with also the potential of treating androgenetic alopecia (AGA).

The U.S. FDA issued an Emergency Use Authorization (EUA) to BinaxNOW developed by Abbott for rapid detection of COVID-19 antigen, which is highly portable (about the size of a credit card), sells for only USD5, and provides detection results within 15 minutes.

Aug. 26

Foundation Medicine under Roche announced that the FDA approved FoundationOne Liquid CDx, the company’s pan-tumor liquid biopsy test product. The product is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic test product, which analyzes 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from the peripheral whole blood of advanced cancer patients and can report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2.

Aug. 25

CSPC announced that its marketing application for the Class 2.2 new drug: Mitoxantrone Hydrochloride Liposome Injection (10ml: 10mg) was accepted by the CDE for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one prior first-line standard therapy.

Innovent’s clinical trial application for the Class 1 new drug: IBI323 was accepted by the CDE, which is an anti-PD-L1/LAG bispecific antibody and also the 4th bispecific antibody applied for a clinical trial by Innovent. Innovent already has anti-PD-1/PD-L1 bispecific IBI318, anti-CD47/PD-L1 bispecific IBI322 and anti-PD1/HER2 bispecific IBI315 in the clinical stage before this.

Exelixi announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for Cabometyx in combination with Opdivo for patients with advanced renal cell carcinoma (RCC). Cabometyx is a tyrosine kinase inhibitor that can inhibit VEGFR-1/2/3, KIT, TRKB, FLT-3, AXL, RET, MET, and TIE-2 and has been approved by the FDA to treat, as a monotherapy, advanced RCC and hepatocellular carcinoma patients.

Sarepta announced that the U.S. FDA accepted the company’s NDA seeking accelerated approval for Casimersen (SRP-4045) and granted a Priority Review designation. Casimersen, a phosphorodiamidate morpholino oligomer (PMO), is engineered to treat specific patients with Duchenne muscular dystrophy (DMD).

EMD Serono under Merck announced that the U.S. FDA accepted its NDA for tepotinib, an oral MET inhibitor, and granted a Priority Review designation, for the treatment of metastatic NSCLC with a MET exon 14 (METex14) skipping mutation in adult patients.

Aug. 24

Qilu Pharmaceutical’s marketing application for the new Class 4 generic drug: Pazopanib Tablets entered the “Under approval” stage, which is expected to be approved soon to become the first generic of the variety in China. As a multi-targeted tyrosine kinase inhibitor, the original drug of pazopanib was approved by the FDA in Oct. 2009, and the drug was approved for its indication of treating renal cell carcinoma in China in Feb. 2017 and was thereafter successfully included in the NRDL (National Reimbursement Drug List of China) Category B List.

Genentech under Roche announced that the U.S. FDA approved the marketing of its Enspryng (satralizumab-mwge) for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

Aug. 14

TG Therapeutics announced that the FDA accepted its NDA for umbralisib indicated for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and follicular lymphoma (FL). Umbralisib is a once-daily oral inhibitor of PI3Kδ and CK1-ε.

Aug. 13

The FDA accelerated the approval of the marketing of Viltepso (viltolarsen) developed by NS Pharma, a subsidiary of Nippon Shinyaku Co., Ltd., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. It is the second targeted therapy approved by the FDA for patients with such a mutation.

Aug. 12

Akeso announced that the indication of PD-1/CTLA-4 bi-specific antibody (AK104), a first-in-class, core new tumor immunotherapy, for the treatment of advanced cervical cancer received the FDA Fast Track Designation (FTD).

ProtalixBio and its partner ChiesiGlobal announced that the FDA accepted the BLA for pegunigalasidase-α and granted a Priority Review designation, with the indication being adult patients with Fabry disease. Pegunigalasidase-α is the company’s purposefully designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A drug.

Regeneron announced that the FDA accepted its BLA for evinacumab treating homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies and granted a Priority Review designation for the application, with the PDUFA target action date being Feb. 11, 2021.

According to the CDE website, the marketing application for the Class 1 new drug: Azvudine Tablets of Henan Genuine Biotech will be included in the priority review for the reason of being an innovative drug or modified new drug that is a short-supplied, clinically urgently-needed pharmaceutical product or can prevent major infectious diseases and rare diseases, etc.

Innovent and Eli Lilly announced that the NMPA accepted the new indication application (sNDA) for Sintilimab Injection (trade name: TYVYT), an innovative PD-1 inhibitor co-developed by both parties, for the first-line treatment of squamous non-small cell lung cancer (NSCLC), which is the 3rd indication of sintilimab applied for in China.

Aug. 11

Dompé Farmaceutici’s marketing application for Cenegermin eye drops in China entered the administrative approval stage, which is expected to be approved soon for the treatment of neurotrophic keratitis.

A clinical trial was approved for Pfizer’s PF-06801591 injection in China to treat high risk, non-muscle invasive bladder cancer. PF-06801591 is a subcutaneously administered anti-PD-1 monoclonal antibody.

Aug. 10

Gilead announced that it filed an NDA for Veklury (remdesivir) to the FDA for the treatment of COVID-19. Remdesivir obtained an Emergency Use Authorization of the FDA on May 1.

Bio-Thera announced that its adalimumab injection (trade name: QLETLI) was approved with a new indication for the treatment of non-infectious intermediate, posterior, and panuveitis in adults, which is the 5th indication of the drug approved in China.

A clinical trial was approved for Boehringer Ingelheim’s 1701963 tablets in China for patients with locally advanced or metastatic colorectal cancer who are positive for KRAS mutation.

Innovent registered the initiation of Phase I clinical study of the Class 1 new drug: IBI112 for single-dose administration in healthy subjects on the China Drug Clinical Trial Registration and Information Publicity Platform. As an anti-IL-23 monoclonal antibody, IBI112 plays an important role in autoimmune disease, rheumatic arthritis, inflammatory bowel disease, and infections.

JS InnoPharm announced the receipt of a Clinical Trial Notice issued by the NMPA, whereupon a clinical trial is approved for its E6201, an inhibitor of mitogen-activated MEK, for treating patients with advanced solid tumors harboring RAS/BRAF/MEK mutations accompanied by brain metastases.

Aug. 7

Chiatai Tianqing’s marketing application for the new Class 4 generic drug: Fulvestrant Injection entered the “Under approval” status, which is expected to be approved to become the first generic of its variety in China. Fulvestrant Injection is a highly sophisticated generic drug used to treat breast cancer.

Aug. 6

Takeda announced the official marketing of its pharmaceutical product: Brentuximab Vedotin for Injection in China for the treatment of adult patients with CD30-positive relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or classical Hodgkin lymphoma (cHL). The drug is the world’s first and only CD30-targeted antibody-drug conjugate.

GSK announced that the U.S. FDA approved its ADC Blenrep as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Aug. 5

According to the CDE website, Nanjing Legend’s LCAR-B38M CAR T-cell autotransfusion formulation appeared in the breakthrough therapy bulletin board and would become the first variety in China to be included in the breakthrough therapy procedure.

Hengrui announced that a Drug Clinical Trial Approval Notice was issued by the NMPA for its SHR-1316 injection, an anti-PD-L1 monoclonal antibody independently developed, and a clinical trial would be conducted for treating limited-disease small-cell lung cancer with the drug soon.

CStone Pharmaceuticals announced that its partner Blueprint Medicines received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”), recommending conditional marketing authorization for avapritinib as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring platelet-derived growth factor receptor αD842V mutation.

Aug. 3

Shanghai Pharma announced that its subsidiary Shanghai Sine’s Telmisartan Tablets received approval for pharmaceutical product supplementary application, making the company the first in passing the generic drug consistency evaluation for the pharmaceutical product in China. Telmisartan tablets are mainly indicated for the treatment of essential hypertension, with the original drug developed by Boehringer Ingelheim and first marketed in the U.S. in 1998.

According to the CDE website, KL-A289 injection, an anti-LAG-3 antibody, jointly applied for by Kelun-Biotech, a subsidiary of Kelun, and Ampsource Biopharma received a clinical trial implied permission for the treatment of advanced solid tumors. No anti-LAG-3 antibody is marketed worldwide at present.

According to the information on pharmaceutical product notices to be collected released on the NMPA website, Pfizer’s ceftaroline fosamil for injection was not approved in China, which might be because of enterprise withdrawal, disapproval, or other reasons. Ceftaroline fosamil belongs to the fifth-generation antibiotics and was approved by the FDA for marketing in Oct. 2010.

Jiangxi Shanxiang Pharmaceutical’s marketing application for the Class 4 generic drug: Sorafenib Tosylate Tablets (acceptance No.: CYHS1800243) changed to “Under approval”, which is expected to be approved to become the first sorafenib generic in China.

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.

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