China Biopharmaceutical (01177) and Cipla signed an exclusive licensing agreement for TQB2102

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the Group's subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing), has signed an exclusive licensing and supply agreement (agreement) with Cipla Limited (Cipla) for the HER2 dual-antibody ADC (rolditamig deuderuxtecan, R&D code: TQB2102) independently developed by the Group.

This is the second regional licensing cooperation reached by TQB2102. Up to now, these two collaborations have brought the Group a total of approximately US$30 million in down payments and milestone payments, which fully reflects the commercial value of this asset and also shows the Group's steady regional cooperation layout.

In accordance with the terms and conditions of the agreement, the Group will grant Cipla an exclusive license to develop and commercialize TQB2102 in India, South Africa and five other emerging markets (authorized regions). Cipla will be responsible for local clinical development, registration and commercialization within the authorized region, and Chia Tai Tianqing will continue to be responsible for the production and supply of TQB2102.

The Group is entitled to receive down payments, potential development, regulatory and sales milestone payments of up to US$123 million, and will also receive double-digit royalties based on TQB2102 net sales.

This cooperation has further advanced the Group's international strategic layout. Relying on the excellent localization capabilities and market access advantages of partners in authorized regions, the Group is committed to bringing late-stage innovative therapies to patients around the world at an accelerated pace. Cipla has been deeply involved in India, South Africa and other emerging markets for many years, and has a mature registration, medical and commercialization system, laying a solid foundation for accelerating the development and commercialization of TQB2102 within authorized regions.

This cooperation is expected to further enhance the global accessibility of this potentially best-in-class HER2 ADC drug after obtaining relevant regulatory approval, while strongly boosting the Group's internationalization process and long-term value growth.

Established in 1935, Cipla is a global pharmaceutical company committed to achieving flexible and sustainable growth, focusing on complex generic drug businesses, and continuing to deepen its product portfolio in local markets such as India, South Africa, and North America, as well as key mature and emerging markets. The company has outstanding strength in respiratory, antiretroviral, urinary, cardiovascular, anti-infective and central nervous system treatment fields, and has an outstanding reputation in the industry. Cipla has 48 production bases around the world. Relying on cutting-edge technology platforms, Cipla produces more than 50 dosage forms and more than 1,500 products, and its business covers more than 70 markets around the world. Cipla is India's third-largest pharmaceutical company (IQVIA MAT June 2026), the second-largest pharmaceutical company in the South African prescription drug market (IQVIA MAT May 2026), and ranked second in the US generic inhaler and metered-dose inhaler market by prescription volume (IQVIA MAT June 2026).

For 90 years, Cipla's mission has been to change patients' lives. In 2001, CiPLA pioneered the launch of triple antiretroviral therapy for HIV/AIDS in Africa, reducing the daily cost of treatment to less than $1. This pioneering initiative was recognized as a major contributor to the inclusiveness, accessibility, and affordability of the global AIDS response. As a responsible corporate citizen, Cipla adheres to the purpose of “caring for life”, practices healthcare in a humanistic spirit, actively integrates into the community and gives back to society in the regions where it operates, and has won the wide trust of global health agencies, industry peers and various stakeholders.

TQB2102 is a next-generation HER2 bi-epitope bispecific antibody drug conjugate (ADC) independently developed by the Group. The drug can simultaneously target the ECD II and ECD IV domains of HER2, and uses lyzable ligands and topoisomerase I inhibitors. The above differentiated design breaks through the limitations of traditional HER2 monoclonal antibodies or single-target ADCs. The double epitope binding mode of TQB2102 can enhance receptor crosslinking and endocytosis efficiency, and has clear differentiating advantages in treating patients with low HER2 expression.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the Group announced the results of a phase Ib clinical study of TQB2102 for advanced breast cancer with low HER2 expression, showing good efficacy and safety characteristics. The overall objective response rate (ORR) was 53.4% (39/73) among patients with low HER2 expression who had previously received multiple lines of treatment (4 lines of median advanced systemic treatment and 2 lines of median palliative chemotherapy). Notably, even among patients who had previously received ADC treatment and disease progression, 44.4% achieved remission after treatment with TQB2102. In terms of safety, only 1 case of interstitial lung disease (ILD) occurred (grade 2), and the incidence rate was 0.55%, which is far lower than other HER2 ADCs.

TQB2102 has been recognized as one of the three breakthrough treatments by the Drug Evaluation Center (CDE) of the China National Drug Administration. Currently, the drug is undergoing a number of phase III clinical studies, covering various types of cancer such as breast cancer with low HER2 expression, HER2 positive breast cancer, colorectal cancer, and biliary tract cancer. The Group will present phase III clinical study data on TQB2102 in the treatment of breast cancer with low HER2 expression in the form of the latest breakthrough summary (LBA) at the 2026 European Society of Medical Oncology (ESMO) annual meeting.