Shanghai Pharma and ImmuneOnco Advance IND Approvals for CD19/CD22 CAR-T with 99.1% CR Rate and HER2 ADC Showing ~95% Disease Non-Progression

May 08, 2025 09:01 CST Updated 09:01

DualityBio

Innovative Molecular Type Drug Developer

Biohealthcare

Developer of Immune Cell Technology

May 8, 2025

eMedClub News

According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）Incomplete statistics from the official website and public data last week(April 28 - May 4)，Approx. 18 itemsBeijing Biohealthcare Biotechnology's innovative drug IND granted clinical implied permission / IND application accepted.(Note: This article only counts new molecular type biologic innovations such as bispecific antibodies, ADCs, and CAR-T.)

The above-mentioned new developments involve bicistronic CD19/CD22 CAR-T with a complete remission rate of 99.1%, autologous cytotoxic T lymphocytes for gastric cancer, and ADCs that prevent disease progression in nearly 95% of patients... Companies involved include Shanghai Pharmaceuticals, Beijing Biohealthcare Biotechnology, and DualityBio.

▲ April 28 - May 4 IND Approved

Biological Innovative Drugs Granted Implicit Approval and IND Application Accepted by CDE

The following will introduce some biopharmaceutical innovations with more publicly available information.

IND Clinical Implied Permission

Duality Bio: BNT323

HER2 ADC

BNT323（DB-1303）It is based on YingBio's immunotoxin antibody conjugation platform. (DITAC) The third-generation HER2-targeted ADC under development is intended for the treatment of endometrial cancer. This ADC utilizes a third-generation topoisomerase I inhibitor as its payload and is linked to the antibody via a cleavable peptide linker, with a drug-to-antibody ratio.（DAR）Approximately 8.

Previous preclinical and preliminary clinical data have shown that, regardless of the expression level of HER2 in solid tumors, BNT323 has the potential to target the HER2 receptor and kill tumor cells. Meanwhile, the safety of BNT323 is controllable, which is expected to further expand the therapeutic window.

According to publicly available data, DualityBio has previously conducted two registrational clinical trials for BNT323.(A global trial and a China trial)And a global potential registration study, the first indication of this ADC(HER2-Expressing Endometrial Cancer)Expected to file for accelerated approval with the FDA as early as 2025.

Beijing Biohealthcare Biotechnology: Autologous Lymphocyte Injection

Multi-target Composite Antigen CTL

According to publicly available data, the autologous lymphocyte injection is an MTCA-CTL with independent intellectual property rights developed by Beijing Biohealthcare Biotechnology.(Multi-target Composite Antigen Cytotoxic T Cells), which is combined with PD-1 monoclonal antibody and XELOX for the treatment of locally advanced unresectable or metastatic gastric cancer.

MTCA-CTL belongs to autologous immune cell therapy technology, and its main feature is to ensure non-Major Histocompatibility Complex（MHC）While restricting the expansion of NK-T cells, MHC-restricted CD8+ specific CTL cells are directionally expanded to reach a ratio of 60%-70% in the cellular product. During expansion, autologous dendritic cells treated with various tumor antigens are added for co-culture to stimulate and induce immune cells, enabling them to specifically recognize and kill tumor cells.

According to the official website of Beijing Biohealthcare Biotechnology, the autologous lymphocyte injection has entered a confirmatory Phase 2 clinical trial in China targeting advanced unresectable/metastatic gastric cancer. Additionally, clinical data presented at the 2023 ASCO Annual Meeting showed that the injection demonstrated encouraging safety and efficacy.

IND Acceptance

Shanghai Pharmaceuticals:B019

CD19/CD22 CAR-T

According to publicly available data, the chimeric antigen receptor autologous T-cell injection targeting CD19 and CD22 is a bicistronic CD19/CD22 CAR-T developed by Shanghai Pharmaceutical. Specific information is as follows:99.1% Complete Remission Rate! Shanghai Pharmaceuticals' Bicistronic CD19/CD22 CAR-T Files for Clinical Trial Again

Yilian Biologics: YL242 for Injection

VEGF ADC

According to official information from Yilian Biotechnology, YL242 for injection is a non-internalizing ADC targeting soluble VEGF, developed based on Yilian Biotechnology's TMALIN platform. It aims to exert anti-tumor activity by combining the anti-angiogenic effects of targeting VEGF with cytotoxic payloads released in the tumor microenvironment.

YL242 Demonstrates Significant Dose-Dependent Tumor Killing Effect in Tumor Xenograft Mouse Models and Shows Good Tolerability in Non-Human Primate Toxicology Studies. Currently, YL242 Has Received Clinical Tacit Approval in Australia.

DualityBio: DB-1311 for Injection

B7-H3 ADC

Injectable DB-1311（BNT324）DB-1303 is a B7-H3 targeted ADC developed by DualityBio. It exhibits strong selectivity by binding to a specific B7-H3 subtype that is overexpressed in tumor cells, and with its highly potent payload, stable linker, and silenced Fc region of the monoclonal antibody, it demonstrates potential for good safety and a broad therapeutic window.

Partial data from a global Phase 1/2a clinical trial showed that DB-1311 demonstrated encouraging anti-tumor activity and manageable safety in patients with locally advanced/metastatic solid tumors who had received multiple prior lines of therapy. The unconfirmed objective response rate was observed in patients with castration-resistant prostate cancer.（uORR）At 28.0%, the 6-month imaging-based progression-free survival rate reached 94.7%。

BeiGene: Injectable BGB-B3227

MUC1/CD16A Bispecific Antibody

According to publicly available information from BeiGene, BGB-B3227 is a MUC1/CD16A-targeted bispecific antibody developed by the company. Previously, the IND application for this antibody targeting advanced or metastatic solid tumors has received clinical tacit approval from the CDE.

MUC1 is an emerging target for cancer immunotherapy, which is overexpressed in a variety of human epithelial malignancies, including breast cancer, prostate cancer, ovarian cancer, pancreatic cancer, and colon cancer, among others, but the level of MUC1 expression is very low in normal tissues. CD16A plays a central role in NK cell-mediated immune responses, and its potential in the development of bispecific antibody new drugs has received widespread attention.

References:

1. CDE official website and each company's official website

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