According to the global clinical trial registry website clinicaltrials and the Chinese Clinical Trial Registry platform chinadrugtrials, a total of 15 innovative drugs entered Phase III in February, five of which are from Chinese pharmaceutical companies. These investigational drugs cover popular targets such as GLP-1, CLDN18.2, and IL-17A, as well as emerging targets like SGCB and CBS. This article highlights five key products for introduction.
Note: 1. Information source:ClinicalTrials andchinadrugtrials。2. Only innovative drugs are registered, excluding minor innovations and biosimilars.3. The same drug initiated multiple Phase III clinical trials on the same day, with combined indications recorded;The same drug inLaunch multiple Phase III clinical trials within one month, with the earliest registrant being the standard.4.CBS：Desulfurization Ether Synthase; SGCB: β-sarcoglycan; RSV: Respiratory Syncytial Virus; CSF-1R:Colony Stimulating Factor-1 Receptor；GALV-GP-R−: R transmembrane peptide of gibbon leukemia virus glycoprotein gene;GM-CSF：Macrophage Colony-Stimulating Factor。Drug:TG103(Tian Shi Zhen Bio)
Indications: Type 2 DiabetesTG103 isI-Mab BiopharmaAndTaslyA long-acting recombinant human GLP-1-Fc fusion protein developed in collaboration, with stable and effective pharmacological effects, good safety, and a long drug half-life. In 2018,CSPC GroupEntered into a cooperation agreement with I-Mab, obtaining the exclusive clinical development and commercialization rights for the drug in China for 150 million RMB.TG103 entered Phase III clinical trials for the first time in August 2023, with obesity as its initial indication. In addition to obesity and type 2 diabetes, which have already advanced to Phase III, CSPC Pharmaceutical Group is also exploring the potential of TG103 in treating non-alcoholic steatohepatitis (NASH) and Alzheimer's disease.The Phase III study, which has just been initiated, is a multicenter, randomized, open-label, active-controlled clinical trial. It plans to enroll 618 adult patients with type 2 diabetes whose blood glucose levels are inadequately controlled by metformin monotherapy. The aim is to compare TG103 (7.5/15mg, once weekly, subcutaneous injection) andDulaglutide(Efficacy, Safety, and Immunogenicity of Once Weekly Subcutaneous Injection)Indications:CLDN18.2-positive gastric cancerCLDN proteins are an important component of tight junctions in epithelial cells. Their abnormal expression or dysfunction can lead to structural damage and functional impairment of epithelial and endothelial cells, making them therapeutic targets or biomarkers for a variety of diseases, including cancer, inflammatory bowel disease, and skin conditions. Among these, CLDN18.2 is primarily expressed in gastric epithelial cells. Studies have found that CLDN18.2 is highly expressed or ectopically activated in primary malignant tumors such as gastric cancer, pancreatic cancer, esophageal cancer, ovarian cancer, breast cancer, and lung cancer. Given its potential for specific expression, it has become an emerging target for anti-cancer therapies.IBI343 is a recombinant human anti-CLDN18.2 ADC. After binding to tumor cells expressing CLDN18.2, it undergoes CLDN18.2-dependent ADC internalization and releases toxin drugs that cause DNA damage, leading to tumor cell apoptosis. The free toxin drugs can also diffuse through the plasma membrane to reach and kill adjacent tumor cells, thus IBI343 also exhibits a bystander effect.IBI343 demonstrated robust anti-tumor activity in both CLDN18.2 low-expression and high-expression tumor-bearing pharmacological models, while showing a favorable safety profile in preclinical models with overall controllable safety.As a popular target, the competition in the CLDN18.2 field has become increasingly fierce. According to the PharmaCube database, there are approximately 59 CLDN18.2-targeted drugs in clinical research by companies in China alone, covering drug types such as monoclonal antibodies, bispecific antibodies, trispecific antibodies, CAR-T therapies, and ADCs. Among the 12 domestically produced CLDN18.2 ADCs that have entered the clinical development stage, IBI343 is the most advanced, being the first product to reach Phase III. Keynoya Biologics/LePu BioOfCMG901AndLixun PharmaceuticalsOfLM-302Immediately following.Indications: RSV InfectionLID/ΔM2-2/1030s (SP0125) is Sanofi andA nasal spray attenuated live vaccine for RSV infection, developed in collaboration with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), is suitable for children of all age groups.
Source: Sanofi 2023 Vaccines R&D DayIt is estimated that the RSV market size will reach 8 billion US dollars in 2030, with huge market potential. Sanofi has made a comprehensive layout in the RSV field and aims to become a leader in this area.
Source: Sanofi 2023 Vaccine R&D DaySanofi's previously deployed RSV neutralizing antibodyBeyfortus(Nirsevimab)Already launched, it can protect newborns from infection during their first RSV season (October to March). However, the product faces fierce competition from RSV vaccines developed by Pfizer and GSK. In addition,ModernamRNA VaccinemRNA-1345Is also about to join this market battle.It can be said that,LID/ΔM2-2/1030s is Sanofi's differentiated strategy in the RSV field. Public information shows,LID/ΔM2-2/1030s can protect newborns from RSV infection during the second epidemic season (April to September of the following year). Therefore,Beyfortus andLID/ΔM2-2/1030s provides a dual defense line that can significantly reduce the likelihood of RSV infection in newborns. Sanofi expects to submit the vaccine's marketing application as early as 2026.
Source: Sanofi 2023 Vaccine R&D DayIn addition, Sanofi has also developed an mRNA vaccine for the elderly population.SP0256To provide protection. The vaccine is currently in Phase I/II clinical trials.Indications: Graft-versus-host diseaseAxatilimab was initially developed by UCB as an anti-CSF-1R monoclonal antibody, and later...Syndax PharmaceuticalsHand over to Incyte.
As of now, there are 17 selective CSF-1R targeted drugs in clinical development globally, five of which are...Anti-CSF-1R monoclonal antibody, whileAxatilimabIt is the fastest progressing product. On February 27 this year, Incyte achieved success in Phase II.Positive Results from AGAVE-201 Study Submitted to FDAAxatilimab for the Treatment of Graft-Versus-Host Disease (GVHD) Marketing ApplicationThe launch of this Phase III study is also aimed at further validation.Efficacy and Safety of Axatilimab in GVHD.
Source: Incyte 2023 Earnings Report PPTGVHD is an immune response of donor-derived hematopoietic cells against recipient tissues, a severe and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation that can persist for years. It is estimated that approximately 40% of transplant recipients will develop chronic GVHD. Chronic GVHD typically manifests in multiple organ systems, commonly involving the skin and mucous membranes, and is characterized by the development of fibrotic tissue.Target: GALV-GP R-/GM-CSFVusolimogene oderparepvec is an enhanced first-in-class oncolytic herpes simplex virus 1 (HSV-1) that expresses the fusogenic glycoprotein GALV-GP-R and macrophage colony-stimulating factor (GM-CSF). GALV-GP-R can induce cell fusion between infected tumor cells through interaction with constitutively expressed phosphate-binding, leading to cell death.December 2023,Replimune Announces Registration-Directed Phase II Clinical Trial for the DrugIGNYTE has been successfully completed. The results showed that, among 156 cases receivingVusolimogene oderparepvec+NivolumabIn patients with melanoma treated, the objective response rate (ORR) was 31.4%, the complete response rate (CRR) was 12%, and the median duration of response (DOR) exceeded 24 months.Replimune hopes to submit the marketing application for this combination therapy and apply for accelerated approval.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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