This week, in China, Nanjing Biosnwill Pharma's Class 2.2 new drug Edaravone Sublingual Tablets and Yichang Humanwell's Class 3 generic drug Clobazam Tablets have been approved by the NMPA for marketing. Meanwhile, new indications have been approved for both Junshi Biosciences' Toripalimab and AstraZeneca's Olaparib Tablets; New progress with the EMA and FDA approvals has been achieved for some popular drugs. For example, Roche's bispecific antibody ophthalmic drug Faricimab has been approved for marketing in the EU. Although there has been nothing new in R&D during the week, on the business side, Chiatai Tianqing entered into a collaboration agreement with Inventiva for the development of lanifibranor, a pan-PPAR agonist. Besides, InnoCare Pharma was successfully listed on the STAR. This week’s news review covers 25 pieces of information in 4 sections, i.e., drug review, R&D, and business and listing.
NMPA – Marketing
1. On September 19, the NMPA official website released the approval that, a new indication for Junshi Biosciences' PD-1 monoclonal antibody, Toripalimab, in combination with standard first-line chemotherapy has been approved for marketing for the treatment of untreated, driver gene (EGFR/ALK)-negative and advanced NSCLC. This is the sixth indication for which Toripalimab has been approved in China.
2. On September 19, the NMPA official website released the approval that, the new indication for AstraZeneca/ MSD's PARP inhibitor Olaparib Tablets has been approved for marketing. It is used for the maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive and advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after complete response or partial response with first-line platinum-containing chemotherapy in combination with bevacizumab. This is the fourth indication for which Olaparib Tablets have been approved in China.
3. On September 19, the NMPA official website released the approval that Nanjing Biosnwill Pharma's new class 2.2 drug Edaravone Sublingual Tablets has been approved for marketing, with an indication of inhibiting the progression of dysfunction caused by amyotrophic lateral sclerosis (ALS). Thus, Nanjing Biosnwill Pharma emerged as the first pharmaceutical company to obtain marketing approval for Edaravone Sublingual Tablets.
4. On September 19, the NMPA official website released the approval that Yichang Humanwell's Class 3 generic drug Clobazam Tablets has been approved for marketing for the treatment of intractable epilepsy known as Lennox-Gastaut syndrome (LGS). Clobazam is a new class of 1,5-benzodiazepine antiepileptic drugs with proven efficacy against epilepsy in pediatric and adult LGS patients aged 2 years old and above.
NMPA – Marketing
5. On September 21, the CDE official website revealed that the marketing application for Orphalan 5.1 class new drug Trientine Hydrochloride Film-coated Tablets has been submitted and processed. Trientine is a copper ion complexing agent that has previously been approved overseas for the treatment of Wilson's disease (hepatolenticular degeneration). It is a rare chronic genetic disease that has been included in the First Catalogue of Rare Diseases in China.
6. On September 21, the CDE official website revealed that the marketing application for the new class 5.1 drug Methylphenidate Hydrochloride Oral Sustained-release for Suspension jointly developed by Pediatrix Therapeutics and Tris Pharma has been submitted and processed. Methylphenidate hydrochloride is a central nervous system (CNS) stimulant for the treatment of attention deficit hyperactivity disorder (ADHD) and can act within 45 minutes.
NMPA – Clinical Trials
7. On September 19, the CDE official website revealed that Otsuka Pharmaceutical's Difamilast Ointment has been approved for the clinical treatment of atopic dermatitis in children and adults. Difamilast is a nonsteroidal topical phosphodiesterase-4 (PDE4) inhibitor that exerts its anti-inflammatory effects by blocking the production of cytokines and chemical mediators.
8. On September 19, the CDE official website revealed that Ribo Bio's RBD7022 Injection has been approved for clinical treatment of primary (familial and non-familial) hypercholesterolemia or mixed hyperlipidemia featuring elevated LDL cholesterol. This is the first siRNA therapy for ASGPR and PCSK9 developed independently by a Chinese pharmaceutical company to be approved for clinical use.
9. On September 20, the CDE official website revealed that Innovent's IBI333 has been approved for clinical treatment of neovascular and age-related macular degeneration. IBI333 is a fully human fusion protein bispecific antibody that targets both VEGF-A and VEGF-C. In a laser-induced choroidal neovascularization model, IBI333 can inhibit free VEGF-A and VEGF-C.
10. On September 21, the CDE official website revealed that Ori-C101 Injection from Oricell Therapeutics has been approved for clinical treatment of advanced hepatocellular carcinoma. Ori-C101 Injection is a fully human antibody sequence targeting GPC3 with high specificity and affinity, and a unique signaling activation element, Ori, which is intended for the treatment of adult patients with advanced hepatocellular carcinoma.
11. On September 19, the CDE official website revealed that the clinical trial application for BRL-201 submitted by BRL Medicine has been accepted. BRL-201 is the world's first CAR-T product targeting CD19 non-viral PD1 sentinel integration, which can obtain genomic sentinel integration CAR-T cell product by one-step preparation without the use of viral vectors.
12. On September 21, the CDE official website revealed that Lepu Biopharma's MRG003 for injection is proposed to be included in the breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma that has failed previous treatment with at least second-line systemic chemotherapy (including platinum-containing chemotherapy) and PD-1 (L1). MRG003 is an ADC drug targeting EGFR on the surface of tumor cells, delivering precisely cytotoxic small molecules to tumor cells via the antibody portion.
FDA - Marketing
13. On September 21, Eli Lilly announced accelerated FDA approval for a new indication of Selpercatinib (Retevmo) for the treatment of patients with locally advanced or metastatic solid tumors with rearranged during transfection (RET) gene fusions. These patients had suffered disease progression after prior systemic therapy or had no other satisfactory alternative treatment. This is the first and only cancer-independent RET inhibitor for the treatment of solid tumors with RET gene fusions in the world.
14. On September 20, Cidara and Melinta Therapeutics jointly announced that the FDA has processed a marketing application for Rezafungin for the treatment of candidemia and invasive candidiasis (IC) and granted it priority review status with a PDUFA date of March 22, 2023. IC is a serious and life-threatening systemic candidiasis that can infect the bloodstream, and deep/invasive tissues.
15. On September 22, Argenx announced that the FDA has processed a Biologics License Application (BLA) for subcutaneous injection of Efgartigimod for the treatment of adult patients with generalized myasthenia gravis. Efgartigimod is a "first-in-class" therapy targeting the Fc receptor, which has been approved for marketing by the FDA in December 2021. Zai Lab has the right to develop and commercialize it in Greater China.
[Orphan Drug Designation]
16. On September 19, Antengene Corporation announced that its self-developed novel PD-L1/4-1BB bispecific antibody ATG-101 injection has been granted orphan drug designation by the FDA for the treatment of pancreatic cancer. At present, there is no PD-L1/4-1BB bispecific antibody approved for the treatment of pancreatic cancer worldwide. In December 2021, as the first new bispecific antibody drug of Antengene Corporation, the clinical trial application of ATG-101 injection has been processed by the NMPA for the treatment of solid tumors and non-Hodgkin's lymphoma.
EMA – Marketing
17. On September 19, Roche announced that Faricimab (Vabysmo) has been approved for marketing by the EMA for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Faricimab is the first VEGF-A/ANG-2 bispecific antibody developed for ophthalmic disease and is the only injectable ophthalmic drug approved in Europe.
18. On September 21, AstraZeneca announced that Tezepelumab (Tezspire) has been approved by the EMA for marketing as an additional maintenance treatment for patients aged 12 years and above with severe asthma. This is the first and only biologic approved by EMA that is not restricted by any phenotype or biomarker for the treatment of patients with severe asthma. Tezspire, a monoclonal antibody targeting TSLP, was co-developed by AstraZeneca and Amgen and has been approved for marketing in the U.S. and other countries.
19. On September 20, UCB announced that EMA has accepted two marketing authorization applications (MAAs) of Bimekizumab for the treatment of adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA). This is the only monoclonal antibody against IL-17A/IL-17F approved for marketing in the world.
Clinical trials launching
20. On September 20, MSD announced that it will initiate a new Phase III clinical trial with once-daily oral Islatravir for the treatment of people with HIV-1 infection, evaluating a once-daily oral combination of doravirine (100 mg) in combination with a lower dose of Islatravir (0.75 mg) (DOR/ISL). The FDA has reviewed and approved the plan. Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) in development that inhibits the function of HIV reverse transcriptase through multiple mechanisms.
21. On September 21, the drug clinical trial registration and information publicity platform of CDE showed that Fosun Pharmaceutical has started an international multicenter (including China) phase II clinical trial of SurVaxM in combination with temozolomide for adjuvant treatment of glioblastoma in primary diagnosis. SurVaxM is a peptide vaccine developed by MimiVax. Fosun Pharma acquired its exclusive clinical development and commercialization rights in China in 2019.
Clinical data release
22. On September 21, Pfizer unveiled the latest study data for PF-06882961 (2 oral doses per day) and PF-07081532 (1 oral dose per day), which showed significant results for glucose-lowering and weight loss compared to placebo. The two are oral small molecule GLP-1 receptor agonists. Currently, Semaglutide Tablets is the only oral GLP-1R agonist marketed in the world.
23. On September 19, Remegen announced that the Phase III confirmatory study of its Telitacicept (Taiai) for treatment of systemic lupus erythematosus (SLE) has been completed and preliminary results were obtained in China. The study met the prespecified clinical endpoints, with a significantly higher rate of SRI-4 (The Systemic Lupus Erythematosus Responder Index 4) response in the Telitacicept group (82.6%) compared to the placebo group (38.1%) at week 52.
24. On September 21, Inventiva announced that it entered into a collaboration agreement with Chiatai Tianqing to jointly develop and commercialize Lanifibranor, a pan-PPAR agonist developed in-house by Inventiva, for the treatment of nonalcoholic steatohepatitis (NASH) and other potential metabolic diseases. Under the terms of the agreement, Inventiva has the potential to receive up to $290 million of clinical, regulatory, and commercial milestone payments.
25. On September 21, InnoCare Pharma got officially listed on the Science and Technology Innovation Board (STAR market) of the Shanghai Stock Exchange. There are two products of InnoCare Pharma approved for marketing, the BTK inhibitor Orelabrutinib and the anti-CD19 antibody Tafasitamab. More than 30 clinical trials are underway worldwide for 13 products of the Company.
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NMPA announced the emergency drug review and approval, and conditionally approved the first-in-class innovative drugs, Simnotrelvir Tablets/Ritonavir Tablets of Hainan Simcere Pharmaceutical and Renmindevir of Shanghai Wangshi Biological Technology.