Breakthrough Week: 10 Cell Therapies and Multiple Bispecific ADCs Achieve Key Milestones, Involving Hengrui Medicine, 3SBio, EnrekaBio, and More [CDE Weekly Update]
RENOCELL BIOTECH
Pharmaceutical R&D and Manufacturing Companies
3SBIOINC
Biopharmaceutical Manufacturer
Rui Therapeutics
A New Generation of Cell-Based Drug Developer
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
September 9, 2025
eMedClub News
According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）According to incomplete statistics from the official website and publicly available information, last week(September 1 - September 7)，More Than 20 Class 1 Innovative Drugs Proposed for Breakthrough Therapy Designation/Granted Clinical Trial Approval by Default/IND Application Accepted, Mainly Covering Hot Fields Such as Cell Therapy and ADC. Notably, Last Week Saw New Progress in 10 Cell Therapy Products, Featuring Diversified Cell Types and Indications.
The following will introduce in detail the cell therapy and ADC pipelines that had more public information disclosed last week.
10 Cell Therapy Products Make New Progress,
Involving MSC, CAR-T/NK, ACC-γδ2 T, etc.
Jiangsu Ruiyuan Biotechnology Co., Ltd.: Umbilical Cord MSC
RY_SW01 Cell Injection, developed by Jiangsu Ruiyuan Biotechnology Co., Ltd., is an umbilical cord mesenchymal stem cell product.（MSC）, proposed by CDE to be included in the breakthrough therapy category for the treatment of systemic sclerosis（SSc）. This indication has been approved for clinical trials in 2023. In addition, it has also been approved for clinical treatment of type 2 diabetic kidney disease and active lupus nephritis.
SSc was included in the first batch of China's rare disease directory in 2018. It is a systemic autoimmune disease characterized by thickened and hardened skin, which can affect internal organs such as the lungs, cardiovascular system, kidneys, and digestive tract, posing a serious threat to patients' quality of life and survival. Compared with traditional therapies, this MSC can regulate immunity through multiple pathways, secrete cytokines to counteract fibrosis, and has no adverse reactions related to immunosuppressants, offering better safety.
Acepodia Biotech：ACC-γδ2 T
Acepodia Biotech's ACE1831 is a product based on its proprietaryAntibody-Cell Conjugation（ACC）The off-the-shelf γδ2 T cell therapy candidate product developed by the platform uses click chemistry technology to conjugate anti-CD20 antibodies.γδ2 T cells, targeting and killing hematological tumors expressing CD20. Utilizing γδ2 T cells with high expression of natural killer.（NK）Characteristics of receptor activation, ACE1831 demonstrated enhanced cytotoxicity against cancer cells in both in vitro and in vivo models.
In addition, the CS1/BCMA dual-target CAR-T introduced by 3SBIOINC has been approved for clinical trials, intended for development to treat relapsed and refractory multiple myeloma; the universal CD19-targeted CAR-NK from Rui Therapeutics has been approved for clinical trials, aimed at treating moderate to severe refractory systemic lupus erythematosus; the first cell therapy product from Ruimedicine (a subsidiary of Hengrui Pharma) has been approved for clinical trials, targeting advanced malignant tumors; umbilical cord MSCs from Regenerative Cell Research Institute and Zhongke Juyan have both been approved for clinical trials, respectively intended for development to treat erectile dysfunction caused by Type 2 diabetes that failed previous treatments and knee osteoarthritis.
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In addition, Huishan Bio's human umbilical cord MSC HS_SW01 cell injection and OncoCell's injectable mesenchymal stem cells(Umbilical Cord)The IND application for QM103 cell injection submitted by Jiqmai Yonghua has been accepted by the CDE.
ADC: Bispecific ADC Achieves Key Breakthrough,
Multiple New Drugs Granted Clinical Tacit Approval for the First Time
ADC is the core hotspot in current pharmaceutical R&D, with bispecific ADC as the next-generation technology direction being the key focus. This week, several bispecific ADCs achieved critical IND progress, and multiple ADCs were granted their first clinical trial approvals by default, with a number of pipelines disclosed as follows:
Baili Tianheng: EGFR/HER3 Targeted ADC
BL-B01D1, a self-developed EGFR/HER3 bispecific antibody-drug conjugate (ADC) by Baili Tianheng, is proposed for inclusion in the breakthrough therapy designation for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
BL-B01D1 is a first-in-class and the only EGFR/HER3 bispecific antibody-drug conjugate (ADC) developed by Baili Tianheng that has entered Phase 3 clinical trials. Its antibody component, SI-B001, can simultaneously target and bind to EGFR and HER3 on tumor cells. In terms of ADC design, BL-B01D1 utilizes a self-developed camptothecin analog, ED04.(Improvements were made to the α-acylamino group of Daiichi Sankyo's Dxd.), the linker uses an Ac connector with a DAR value of 8.
Recently, the interim analysis of the Phase 3 clinical trial for BL-B01D1 in treating nasopharyngeal carcinoma has reached its primary endpoint. This is the world’s first bispecific antibody-drug conjugate (ADC) to complete a Phase 3 clinical study. The disclosed Phase 1 data showed that among 24 treated patients, the ORR was 45.8%, and the DCR was 100%.
DuoXi Biologics: B7 H3/PSMA Targeted ADC
DuoXi Biologics' Investigational New Drug Application for DXC014 Injection Approved for Clinical Trials, Intended for the Treatment of Advanced Solid Tumors. Public data shows that DXC014 is an innovative bispecific antibody-drug conjugate (ADC) targeting B7-H3 and PSMA, utilizing a topoisomerase I inhibitor as the payload. This dual-target design aims to enhance therapeutic efficacy against various solid tumors, particularly prostate cancer.
In vitro studies have shown that DXC014 binds to B7H3 and PSMA with high specificity and affinity, enabling precise targeted cytotoxicity. DXC014 exhibits a significant bystander effect while inducing DNA damage in cancer cells, thereby killing both target-positive cells and surrounding target-negative cells. Additionally, DXC014 demonstrates broad cytotoxic activity across various cancer cell lines.
Minghui Pharma: PSMA-Targeted ADC
Minghui Pharma's Injectable MHB048C Receives First Clinical Approval in China, Intended for Development to Treat Advanced Solid Tumors, Including Metastatic Castration-Resistant Prostate Cancer（mCRPC）Patients, and other patients with advanced solid tumors.
Public information shows that this is a PSMA-targeted ADC, composed of a human IgG1 antibody against PSMA conjugated with the SuperTopoi payload. SuperTopoi is a novel DNA topoisomerase I inhibitor, with efficacy 3 to 5 times higher than DXd. The drug-to-antibody ratio is approximately 4.0.
Simcere Pharma: CDH17-Targeted ADC
Simcere Pharma's SIM0609 for injection has been approved for clinical trials for the first time, intended for development to treat locally advanced/metastatic solid tumors. According to publicly available information, SIM0609（SCR-A008）It is a novel targeted cadherin-17.（CDH17）ADC candidate drug, with anti-CDH17 humanized monoclonal antibody and a novel topoisomerase 1 inhibitor（CPT116）Conjugated through a hydrophilic cleavable linker. CDH17 is expressed in limited amounts in normal human tissues but is highly expressed in various gastrointestinal tumors such as gastric cancer, colorectal cancer, and pancreatic cancer, making it a potential therapeutic target for related tumors, especially gastrointestinal tumors.
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