On August 27, Sino Biopharmaceutical Limited (SBP Group, 1177.HK) announced that its subsidiary, Chia Tai Tianqing, has entered into an exclusive licensing and supply agreement with Cipla Limited (Cipla) for Rolditamig Deuderuxtecan (TQB2102). TQB2102 is a potential Best-in-Class (BIC) HER2 dual-antibody ADC independently developed by Chia Tai Tianqing. This collaboration covers India, South Africa, and a total of 7 other high-growth emerging market countries, which will accelerate the delivery of this innovative product to more breast cancer patients.

Under the terms of the agreement, SBP Group will grant Cipla an exclusive license to develop and commercialize TQB2102 in India, South Africa, and five other emerging markets (the licensed territories). Cipla will be responsible for local clinical development, regulatory filings, and commercialization within the licensed territories, while Chia Tai Tianqing will continue to be responsible for product manufacturing and supply. SBP Group is entitled to receive an upfront payment, potential development, regulatory, and sales milestone payments of up to 123 million US dollars, as well as double-digit royalties on TQB2102.

This is the second regional licensing collaboration for TQB2102, which has so far brought the Group approximately 30 million US dollars in upfront and milestone payments.

From 2024 to 2030, the global innovative drug market is projected to grow from approximately 1.08 trillion US dollars to 1.5 trillion US dollars, with emerging markets expected to contribute over 35% of this growth. This collaboration covers high-growth emerging market regions such as South Asia and Africa. With their large populations, rapidly growing healthcare needs, and continuously improving regulatory and payment systems, these markets are expected to add further momentum to the Group's innovative drug revenue growth.

Cipla has a long-standing and deep presence in India, South Africa, and other emerging markets. It has established mature regulatory, medical, market access, and commercialization systems in many of the countries covered by the agreement, and has formed an extensive network of cooperation with local healthcare professionals and institutions. Through this collaboration, Chia Tai Tianqing's innovative R&D and manufacturing capabilities will synergize with Cipla's strengths in local market insights, regulatory execution, and commercial coverage, accelerating the clinical development, registration, and commercialization process of TQB2102 in the licensed territories.

Eric Tse, Chief Executive Officer of SBP Group:

Expanding the global accessibility of drugs independently developed by SBP Group is a key component of our development strategy. TQB2102 has shown encouraging clinical potential in breast cancer patients with different levels of HER2 expression. Cipla has extensive market coverage, deep local experience, and a steadfast commitment to improving patient access to medicines, making them the ideal partner to help us bring this therapy to patients in India, South Africa, and other emerging markets.

Achin Gupta, Managing Director and Global CEO of Cipla:

Cipla is always committed to improving access to high-quality, differentiated therapies in areas with significant unmet clinical needs. Breast cancer is a major health challenge in many of our business markets. This collaboration is an important step for Cipla to further strengthen its tumor product portfolio with a promising HER2 dual-antibody ADC. We look forward to working with SBP Group to advance the local development of TQB2102 and, upon receiving relevant regulatory approvals, bring this innovative therapy to patients in the licensed regions.

TQB2102 is a new-generation HER2 dual-antibody ADC with BIC potential, independently developed by Chia Tai Tianqing. It can simultaneously target the ECD II and ECD IV domains of HER2 and utilizes a cleavable linker and a topoisomerase I inhibitor payload. This differentiated dual-epitope binding design can overcome the limitations of traditional HER2 monoclonal antibodies or single-target ADCs, further enhancing receptor cross-linking and endocytosis efficiency, and has a clear differentiated advantage in patients with low HER2 expression.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, SBP Group announced the results of a Phase Ib clinical study of TQB2102 for HER2-low advanced breast cancer. In heavily pretreated HER2-low patients (median of 4 lines of prior systemic therapy for advanced disease, median of 2 lines of palliative chemotherapy), the overall objective response rate (ORR) reached 53.4% (39/73). Notably, among patients who had previously received ADC therapy and experienced disease progression, 44.4% still achieved a response after treatment with TQB2102. In terms of safety, only one case of interstitial lung disease (ILD) (Grade 2) occurred, with an incidence of 0.55%, which is much lower than other HER2 ADCs.

TQB2102 has been granted three Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. Currently, the drug is advancing in multiple Phase III clinical studies, covering several cancer types including HER2-low breast cancer, HER2-positive breast cancer, colorectal cancer, and biliary tract cancer.

This collaboration with Cipla further expands the overseas presence of TQB2102 to India, South Africa, and several other emerging market countries, further validating the international cooperation value of SBP Group's innovative assets. SBP Group has always adhered to innovation-driven development. While strengthening its independent R&D and global clinical development capabilities, it has established diverse collaboration models with local leading pharmaceutical companies such as Tempo Scan and Cipla to accelerate the global development and value realization of innovative drugs, allowing more innovative therapies originating from China to benefit patients worldwide.

About Cipla Limited

Founded in 1935, Cipla is a global pharmaceutical company with a presence in over 70 markets worldwide. It has 46 manufacturing sites globally, with a product portfolio covering more than 50 dosage forms and over 1,500 products. It has a renowned reputation in therapeutic areas such as respiratory, anti-retroviral, urology, cardiovascular, anti-infective, and central nervous system. According to IQVIA data, Cipla is the third-largest pharmaceutical company in India, the second-largest in South Africa's prescription drug market, and ranks second by prescription volume in the U.S. generic inhaler and metered-dose inhaler market. Cipla operates under the purpose of "Caring for Life" and practices its healthcare mission with a humanitarian spirit, earning the widespread trust of global health organizations, industry peers, and various stakeholders.