Cipla, China's SBP Group Ink Exclusive Deal to Develop, Commercialise Cancer Drug TQB2102 in India, South Africa

Under the agreement, SBP Group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) has granted Cipla exclusive rights to develop and commercialise TQB2102 in India, South Africa and five other emerging markets.

Cipla will be responsible for local clinical development, regulatory activities and commercialisation in the licensed territories, while CTTQ will continue to manufacture and supply TQB2102.

The collaboration is aimed at accelerating the development and future access to TQB2102 for patients with breast cancer across the licensed territories, subject to applicable regulatory approvals.

TQB2102 is being evaluated across HER2-expressing cancers and has demonstrated encouraging clinical potential in HER2-low advanced breast cancer. The companies said the partnership combines SBP Group's late-stage oncology asset and development and manufacturing capabilities with Cipla's regulatory, medical, market access and commercial presence across India, South Africa and other emerging markets.

Commenting on the partnership, Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla said, “At Cipla, innovation is central to our mission of expanding access to therapies that address unmet patient needs. Breast cancer remains a significant healthcare challenge, and this agreement strengthens our oncology portfolio with a promising HER2-targeted antibody-drug conjugate. Through our partnership with SBP Group and CTTQ, we aim to accelerate development and, subject to regulatory approvals, expand access to this innovative treatment across licensed territories.”

“Expanding global access to medicines developed by SBP Group is a central part of our strategy,” said Eric Tse, CEO, SBP Group. “TQB2102 has demonstrated encouraging clinical potential across different HER2-expressing breast cancer populations. Cipla’s scale, local expertise and commitment to patient access make it a strong partner to help bring this treatment to patients across India, South Africa and other emerging markets.”

What Is Rolditamig Deuderuxtecan?

Rolditamig Deuderuxtecan, also known as TQB2102, is a next-generation HER2 dual-epitope bispecific ADC independently developed by SBP Group.

The drug simultaneously binds to the ECD II and ECD IV domains of HER2 and incorporates a cleavable linker and topoisomerase I inhibitor payload. According to the companies, its differentiated design is intended to overcome limitations associated with conventional HER2 monoclonal antibodies or single-target ADCs.

The dual-epitope binding mode may enhance receptor cross-linking and endocytosis efficiency, potentially providing differentiated benefits in patients with HER2-low expression.

Rolditamig deuderuxtecan has received three Breakthrough Therapy Designations from the Center for Drug Evaluation of China's National Medical Products Administration.

The candidate is currently being evaluated for HER2-low and HER2-positive breast cancer, colorectal cancer and biliary tract cancer across multiple treatment settings.

Sino Biopharmaceutical Limited, or SBP Group, is an R&D-driven pharmaceutical company in China with capabilities spanning drug research and development, manufacturing and commercial sales.

The company has an oncology portfolio covering targeted therapies, immunotherapies, biologics, bispecifics, ADCs and supportive care across multiple tumour types, including lung, breast, gastrointestinal, gynaecological, thyroid, renal and haematological cancers.

Cipla is a global pharmaceutical company focused on complex generics and its markets in India, South Africa, North America and other regulated and emerging markets.

The company has 48 manufacturing sites globally producing more than 50 dosage forms and 1,500 products for 69 markets. Its key therapeutic areas include respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments.