Abstract : On March 3, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that the clinical trial application for Gusekimumab injection (acceptance number: CXSL2600293), independently developed by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chia Tai Tianqing Pharmaceutical Group, had been formally accepted, with a registration category of Class 3.3 biological products. At the same time, several other Class 1 innovative biological drugs independently developed by Chia Tai Tianqing, including the HER2 bispecific antibody TQB2930, the HER2 dual-epitope ADC TQB2102, and the EGFR/c-Met bispecific antibody TQB2922, also appeared frequently on the CDE's acceptance list, demonstrating the company's strong R&D capabilities in the field of biological drugs.
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I. Gusekimumab Injection: Targeting IL-23, Expanding into the Autoimmune Field
On March 3, the CDE (Center for Drug Evaluation) updated its "Accepted Drug Information" section, showing that Chia Tai Tianqing Pharmaceutical Group's application for Gusekirumab injection (CXSL2600293) has been accepted. The drug type is therapeutic biological product, and the application type is new drug. This is an important step for Chia Tai Tianqing in its strategic layout in the field of autoimmune diseases, marking the company's official entry into the IL-23 target track.
Gusekimumab is the world's first approved fully human monoclonal antibody targeting the IL-23 p19 subunit. It exerts its anti-inflammatory effect by specifically blocking IL-23 signaling and inhibiting the release of downstream pro-inflammatory cytokines. The original drug was developed by Johnson & Johnson and marketed under the brand name "Tenoate," and has been approved for various autoimmune diseases, including moderate to severe plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.
"The IL-23/IL-17 axis is a key pathway in the pathogenesis of autoimmune diseases. The precise targeting of gusejinuumab has enabled it to demonstrate excellent efficacy and long-term effectiveness in areas such as psoriasis and inflammatory bowel disease." A rheumatology and immunology expert said, "Chia Tai Tianqing's investment in gusejinuumab is expected to provide more accessible treatment options for patients in China."
II. Multiple pipelines launched simultaneously: From bispecific antibodies to ADCs, innovative oncology drugs are being rapidly advanced.
Among the drugs accepted by the CDE this time, several Class 1 innovative biological drugs from Chia Tai Tianqing Pharmaceutical Group are particularly noteworthy, demonstrating the company's strong presence in the field of oncology treatment:
TQB2930 Injection (HER2 Bispecific Antibody) : As a bispecific antibody targeting HER2 independently developed by Chia Tai Tianqing Pharmaceutical Group, TQB2930 can simultaneously bind to both ECD2 and ECD4 epitopes of HER2, achieving synergistic blocking of oncogenic signals. Currently, this drug has entered Phase III clinical trials, focusing on later-line treatment of HER2-positive recurrent/metastatic breast cancer, especially for patients who have failed or are intolerant to novel HER2 ADC therapy. Phase Ib/II data presented at ASCO 2025 showed an objective response rate (ORR) of 48.1%, bringing new hope to resistant patients.

TQB2102 for Injection (HER2 Dual Epitope ADC) : This is Chia Tai Tianqing's first ADC drug, employing a dual epitope targeting design to simultaneously recognize two non-overlapping epitopes of HER2, significantly improving tumor selectivity and endocytosis efficiency. In a phase II study of neoadjuvant therapy for HER2-positive breast cancer, TQB2102 monotherapy achieved an overall pathological complete response (tpCR) rate of 73.1%, surpassing the current standard therapy of chemotherapy combined with dual-targeted therapy. The relevant findings have been published in the top international journal *Journal of Clinical Oncology* (JCO).

TQB2922 Injection (EGFR/c-Met Bispecific Antibody) : This drug is a bispecific antibody targeting EGFR and c-Met, which can simultaneously block two key tumor growth signaling pathways and activate the immune system to kill tumor cells. Currently, TQB2922 is advancing clinical trials for various advanced malignancies such as non-small cell lung cancer and colorectal cancer, showing great potential, especially in overcoming resistance to third-generation EGFR drugs and c-Met amplification.

III. Corporate Strategy: A Comprehensive Transformation from a "Leading Chemical Drug Manufacturer" to a "Biopharmaceutical Innovator"
Chia Tai Tianqing Pharmaceutical Group, a core enterprise in China's biopharmaceutical industry, has long been renowned for its chemical drug research and development, but in recent years it has accelerated its transformation towards biopharmaceuticals and innovative drugs. In addition to the gusechiumab injection that has been accepted for approval this time, the company has already made inroads into several cutting-edge fields such as PD-1/PD-L1 inhibitors, bispecific antibodies, and ADCs, forming a rich pipeline of innovative drugs.
"Our goal is to build an innovation platform driven by both chemical drugs and biologics, covering multiple therapeutic areas such as oncology, autoimmune diseases, and infections," said a representative from Chia Tai Tianqing Pharmaceutical Group. "The acceptance of our 'Gusekimumab injection' application represents a significant breakthrough in the field of autoimmune diseases; while the intensive progress of innovative oncology drugs such as TQB2930 and TQB2102 demonstrates our determination and strength in biologics research and development."
With several innovative drugs entering critical clinical stages, Chia Tai Tianqing Pharmaceutical Group is gradually transforming from a "generic drug leader" to an "innovative drug pioneer." Industry analysts believe that the successful development and launch of these products will not only enhance the company's core competitiveness but also bring more internationally leading treatment options to Chinese patients.
In conclusion , amidst the global wave of pharmaceutical innovation, Chinese pharmaceutical companies are transforming from "followers" to "leaders." Chia Tai Tianqing Pharmaceutical Group's intensive investment in biopharmaceuticals, particularly its breakthroughs in cutting-edge technologies such as bispecific antibodies and antibody-drug conjugates (ADCs), vividly exemplifies this transformation. We look forward to Gusecikumab injection and other innovative drugs achieving excellent results in clinical trials, benefiting more patients as soon as possible, and contributing even more to pharmaceutical innovation in China.
https://mp.weixin.qq.com/s/0SV5y3H3n085Zh8sC4YHUA