China Adds Five Breakthrough Cancer Therapies in August: Innovations from Hansoh Pharma, Alphamab, and Others
Alphamab Oncology
Developer of Antibody and Protein Macromolecule Drugs
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
▎WuXi AppTec Content Team Report
In August 2024, which has just concluded, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted Breakthrough Therapy designation to six new drugs. Among them, five are being developed for cancer treatment, and these investigational anti-cancer products include:HER2 small molecule inhibitor, ADC targeting Nectin-4, anti-BCMA×CD3 bispecific antibody, subcutaneously injectable anti-PD-L1 monoclonal antibody, and third-generation EGFR-TKI。
New drugs included in the "Breakthrough Therapy Designation" list often target severe diseases and have shown significantly better efficacy or safety in early clinical trials compared to existing treatments. This article will introduce these new drugs based on publicly available information.
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Boehringer Ingelheim, China Biologic Products: BI 1810631 Tablets
Mechanism of Action: HER2 Small Molecule Inhibitor
Indications: Non-Small Cell Lung Cancer
Boehringer Ingelheim's BI 1810631 Tablets Included in CDE’s Breakthrough Therapy Designation for TreatmentAdult patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) who are positive for human epidermal growth factor receptor-2 (HER2) and have previously received systemic therapy.This is an orally administered selective HER2 tyrosine kinase inhibitor (TKI). In April this year, China Biologic Products entered into a collaboration with Boehringer Ingelheim to co-develop and commercialize multiple oncology drug pipelines in mainland China, including zongertinib (BI 1810631).
According to the Boehringer Ingelheim press release, the inclusion of zongertinib as a breakthrough therapy is based on the results of the Beamion LUNG-1 clinical trial. The phase 1a trial data showed that among 41 evaluable NSCLC patients, the objective response rate (ORR) was 54%.Disease Control Rate (DCR) was 93%, with an overall median duration of response (mDoR) of 15.8 months. The median progression-free survival (mPFS) for NSCLC patients in the once-daily dose escalation group was 12.3 months. The Phase 1b study only enrolled HER2 mutation-positive NSCLC patients, and the first interim analysis has been completed, with patients showingORR/DCR were 74% and 91%, respectively.。
Mabwell: 9MW2821
Mechanism of Action: ADC Targeting Nectin-4
Indications: Urothelial Carcinoma
9MW2821, filed by Mabwell Bio, has been included in the CDE's breakthrough therapy designation for use inLocally Advanced or Metastatic Urothelial Carcinoma That Has Failed Prior Platinum-Based Chemotherapy and PD-(L)1 Inhibitor Treatment。9MW2821is aAntibody-Drug Conjugates (ADC) Targeting Nectin-4, which has currently launched first-line treatment for urothelial cancer in China.Phase 3 pivotal registration clinical study.
In June this year, Mabwell presented an oral report on 9MW2821 for multiple advanced solid tumors at the American Society of Clinical Oncology (ASCO) Annual Meeting.Phase 1/2 Clinical StudyResults and Latest Developments,Indications involved in the study includeUrothelial Carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancerand other advanced solid tumors.Among them,In 37 evaluable casesPatients with urothelial carcinomaIn China,ORRAt 62.2%,DCRThe ORR was 91.9%, mPFS was 8.8 months, and mOS was 14.2 months.
Zhirong Jintai: GR1803 Injection
Mechanism of Action: Anti-BCMA×CD3 Bispecific Antibody
Indications: Multiple Myeloma
Zhi Xiang Jin Tai's applicationGR1803 Injection Granted Breakthrough Therapy Designation by CDE for the Indication of Patients Who Have Received at Least Three Prior Lines of Therapy (a Proteasome Inhibitor, an Immunomodulatory Agent, and an Anti-CD38 Monoclonal Antibody)Relapsed/Refractory Multiple Myeloma (RRMM). Public information shows,GR1803 is aRecombinant Humanized Anti-BCMA×CD3 Bispecific AntibodyThe abstract of the Phase 1 clinical study for the treatment of RRMM with this product has been selected for the 2024 European Hematology Association (EHA) Annual Meeting. In the Phase 1 clinical study, RRMM patients received this product via intravenous injection once a week.The overall objective response rate (ORR) was 85%., including the overall efficacy evaluation of baseline subjects with extramedullary plasmacytoma (EMM)ORR is 100%。
Alphamab Oncology, 3D Medicines: Recombinant Humanized PDL1 Single-Domain Antibody Fc Fusion Protein Injection
Mechanism of Action: Subcutaneous Injection of Anti-PD-L1 Monoclonal Antibody
Indications: High Tumor Mutation Burden (TMB-H) Solid Tumors
Alphamab Oncology and 3D MedicinesJoint DeclarationRecombinant Humanized PD-L1 Single-Domain Antibody Fc Fusion Protein Injection——EnvonliumabIncluded in the breakthrough therapy category for patients who have failed prior standard treatments and have no satisfactory alternative treatment options.High Tumor Mutation Burden (TMB-H) Unresectable or Metastatic Solid Tumors。Notably, in recent years, among the "tumor-agnostic" new drug projects approved by the U.S. FDA, high tumor mutational burden (TMB) is one of the biomarkers being used.
Envonli Injection (KN035）It is aSubcutaneous Injection of Anti-PD-L1AntibodyMedicine,Patients do not need to undergo intravenous infusion; the administration can be completed within 30 seconds, significantly reducing the administration time and offering the potential for self-administration at home. This product previouslyApproved for marketing in China, indicated for the treatment of adult patients with advanced solid tumors that are unresectable or metastatic, with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
Hansoh Pharma: Aumolertinib Mesylate Tablets
Mechanism of Action: Third-Generation EGFR-TKI
Indications: Non-Small Cell Lung Cancer
Hansoh Pharma's Aumolertinib Mesylate Tablets Included in CDE’s Breakthrough Therapy Designation for Patients Without Disease Progression After Platinum-based Radical ChemoradiotherapyUnresectableBureauPartial advanced epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) Substitution Mutation in Non-Small Cell Lung CancerPatient Treatment.Almonertinib is aThe third-generation EGFR-TKI.Notably, the marketing application for Aumolertinib for this indication was accepted by the CDE on August 20th. This is also the fourth indication marketing application submitted for Aumolertinib tablets in China.
According to the introduction in Hansoh Pharma's press release,Phase 3 HS-10296-304 study has evaluated the efficacy of Aumolertinib Mesylate versus placebo in treatment.The efficacy and safety of the study in patients with NSCLC, which targets the indication included in this breakthrough therapy designation, with the primary endpoint being PFS assessed by an independent review committee.
Tianzeyun Tai: VGR-R01
Mechanism of Action: Gene Therapy Products
Indications: Bietti's Crystalline Dystrophy (BCD)
VGR-R01, a biologic developed by Tianzeyun Tai, is proposed to be included in the breakthrough therapy category for treatment.Bietti's Crystalline Dystrophy (BCD)VGR-R01 is a gene therapy product. In terms of administration, this gene therapy is delivered via subretinal injection and only requires a single injection to potentially achieve long-term efficacy.
According to the press release from Tianze CloudTech, the company conducted two clinical studies on VGR-R01, enrolling Yuzawa stage 2 or 3 BCD patients with BCVA ≤60 ETDRS letters, i.e., ≥0.5 logMAR, and central foveal retinal thickness (CFT) of 96~274μm. The results of the two studies showed that,In Phase 2~3 BCD patients, regardless of the presence of retinochoroidal atrophy, VGR-R01 is expected to benefit patients, including improved visual acuity and enhanced functional vision.. Currently, a multicenter phase 3 study is being prepared.
In addition to the aforementioned products, the recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection (Vero cells) submitted by Virogin Biotech was also accepted by the CDE on August 29.Proposed for Inclusion in Breakthrough Therapy Designation, for advanced hepatocellular carcinoma that has failed standard treatment. This proposed breakthrough therapy designation is currently still under public notice.
We look forward to the smooth progress of subsequent clinical studies of these investigational new drugs, which will bring new treatment options to more patients as soon as possible.
[2] Official websites of various companies and publicly available information
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