Three Zhangjiang Pharma Valley Companies Achieve Clinical Development Breakthroughs

Dec 22, 2025 18:22 CST Updated 18:22

Novabio Therapeutics

Developer of Multi-Modal Treg Cell Therapy

Recently, Zhangjiang Pharm Valley companies have made significant progress in the fields of autoimmune diseases and rare diseases, continuously accelerating the development of drugs for unmet clinical needs, thereby benefiting patients earlier.

Yiming Angke's Subcutaneous Formulation IMM0306S for Amurelimumab Alpha Receives Clinical Research Application Acceptance, Marking a New Breakthrough in Systemic Lupus Erythematosus Treatment

On December 18, Zhangjiang Pharm Valley CompanyYiming AngkeAnnounced that the clinical trial application for Amurefup α (subcutaneous injection formulation) IMM0306S, a bispecific antibody-receptor recombinant protein drug independently developed by the company that simultaneously targets CD47 and CD20, for the treatment of systemic lupus erythematosus (SLE), has been accepted by the National Medical Products Administration (NMPA). This marks an important advancement in the company's innovative drug development in the field of autoimmune diseases.

IMM0306S is a subcutaneous formulation developed based on Yiming Angke's core product, Amurefup α (IMM0306). Amurefup α (CD47xCD20, IMM0306) is the world’s first CD47xCD20 bispecific molecule to enter clinical stage, developed using Yiming Angke's "mAb-Trap" technology platform. The company has currently implemented a comprehensive strategic layout for this product.

IMM0306S is administered via subcutaneous injection, which can significantly reduce the peak blood concentration and effectively decrease targeted blood toxicity and off-target effects, further enhancing drug efficacy. Additionally, this route of administration demonstrates superior overall safety profiles and better tolerability, reducing the incidence of infusion-related reactions. In terms of convenience, subcutaneous injection eliminates the need for venous access, greatly simplifying the administration process and shortening treatment time. It also enables future self-administration in outpatient or home settings, significantly improving patient compliance and treatment flexibility.

NOVABIOTX Regulatory T Cell (Treg) Therapy Product Receives CDE Approval Again, Ushering in a New Journey for Multiple System Atrophy (MSA) Clinical Research

On December 17, Zhangjiang Pharm Valley CompanyNOVABIOTXAnnounced that the clinical trial application for its self-developed "Human Autologous Polyclonal Regulatory T-Cell Injection" has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with the indication being Multiple System Atrophy (MSA). This marks a significant breakthrough in the clinical development of this therapy for MSA, bringing new hope to patients worldwide suffering from this rare disease, for which there is currently no effective treatment.

Dr. Lü Mingqi from NOVABIOTX stated that MSA is classified as one of the Parkinson's plus syndromes under the category of parkinsonism. Compared with Parkinson's disease, it usually progresses faster, has a poorer prognosis, and shows limited response to existing drug treatments, making it one of the most challenging neurodegenerative diseases to treat. The team will accelerate the preparation of clinical trials and quickly initiate this clinical study covering two major subtypes of MSA. The study will systematically evaluate the safety, tolerability, and preliminary efficacy of Treg cells (i.e., NP001 cell injection), further explore their therapeutic potential in different MSA subtypes, and strive to bring clinical benefits to a broader patient population while laying a solid data foundation for optimizing subsequent development strategies.

VGR-R01 from Tianze Cloud-Tech Receives EMA PRIME Designation

Recently, Zhangjiang Pharm Valley CompanyTianze CloudTechAnnouncement: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has agreed to grant VGR-R01 the Priority Medicines (PRIME) designation for the treatment of crystalline retinopathy, supporting its development and accelerated assessment.

"Priority Medicines (PRIority MEdicines, PRIME)" is an accelerated program launched by the EMA in 2016. It aims to support the development of medicines addressing unmet clinical needs by enhancing interactions with medicine applicants, strengthening scientific guidance, optimizing development plans, and ensuring that the generated data meets the requirements of the MAA, thereby enabling patients to benefit earlier.

VGR-R01 is a gene therapy product based on recombinant adeno-associated virus (rAAV) independently developed by Tianze Cloud Therapeutics. In November 2022, it received approval from the NMPA to conduct clinical trials for the treatment of BCD, making it the world's first therapeutic drug for this indication to enter the registrational clinical stage. Previously, VGR-R01 was included in Stage C of the CDE’s "Care Program" in December 2024; granted orphan drug designation by the FDA in October 2024; and approved by the CDE for inclusion in the breakthrough therapy drug program in August 2024.

Source: Yiming Angke Biomedical Technology(Shanghai) Co., Ltd., NOVABIOTX, Shanghai Saierxin Biomedical Technology Co., Ltd.