Cipla, SBP Group Sign Deal for HER2 Cancer Drug

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Image Courtesy: Cipla

Cipla Limited and Sino Biopharmaceutical Limited (SBP Group) have entered into an exclusive licensing and supply agreement for Rolditamig Deuderuxtecan, also known as TQB2102, a next-generation HER2 bispecific antibody-drug conjugate (ADC). Under the agreement, Cipla will receive exclusive rights to develop and commercialise TQB2102 in India, South Africa and five other emerging markets. Cipla will handle local clinical development, regulatory activities and commercialisation in the licensed markets, while SBP Group subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) will continue to manufacture and supply the drug.

TQB2102 is being studied for cancers that express HER2 and has shown encouraging clinical potential in patients with HER2-low advanced breast cancer. The drug is also being evaluated in HER2-positive breast cancer, colorectal cancer and biliary tract cancer across different treatment settings. The partnership combines SBP Group’s oncology research and drug development capabilities with Cipla’s established regulatory, medical, market access and commercial network in India, South Africa and other emerging markets.

Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla, said the agreement strengthens the company’s oncology portfolio and supports its focus on expanding access to treatments for 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,” Gupta said. He added that Cipla aims to accelerate development and expand access to the treatment in the licensed markets, subject to regulatory approvals.

Eric Tse, CEO, SBP Group, said expanding international access to medicines developed by the company is an important part of its strategy. He said TQB2102 has shown encouraging clinical potential across different HER2-expressing breast cancer populations and that Cipla’s local expertise and market presence make it a strong partner.

Rolditamig Deuderuxtecan is a HER2 dual-epitope bispecific ADC developed by SBP Group. It is designed to bind simultaneously to two different regions of the HER2 protein, known as ECD II and ECD IV. The drug also uses a cleavable linker and a topoisomerase I inhibitor payload. The company said this design is intended to improve receptor binding and internalisation and potentially address some limitations associated with conventional HER2 antibodies and single-target ADCs. TQB2102 has received three Breakthrough Therapy Designations from the Center for Drug Evaluation of China’s National Medical Products Administration.

Established in 1935, Cipla operates across more than 80 countries with 46 manufacturing facilities producing over 1,500 products in more than 50 dosage forms. The company continues to strengthen its presence in India, North America, South Africa and other global markets while advancing its commitment to improving access to quality healthcare through innovation and affordable medicines.