Cipla to Develop and Sell Experimental HER2 Cancer Drug in India, South Africa and Five Other Markets

Cipla Secures Rights to Experimental HER2 Cancer Drug in Seven Markets

India's Cipla Ltd has signed an exclusive licensing agreement with China's Chia Tai Tianqing Pharmaceutical Group (CTTQ) to develop and commercialise an experimental HER2-targeted cancer drug, Rolditamig Deuderuxtecan, also known as TQB2102, in India, South Africa and five other emerging markets. Under the agreement, as reported by CNBC TV18 and The Financial Express, Cipla will handle local clinical development, regulatory approvals and commercialisation in the licensed territories, while CTTQ will continue to manufacture and supply the drug. The companies did not disclose the financial terms of the agreement.

The partnership combines SBP Group's oncology pipeline with Cipla's regulatory and distribution network in emerging markets, the companies said. Cipla Managing Director and Global CEO Achin Gupta said the agreement strengthens the company's oncology portfolio with a promising HER2-targeted antibody-drug conjugate and could help accelerate development and patient access, subject to regulatory approvals.

What is TQB2102?

TQB2102 is a bispecific antibody-drug conjugate (ADC), a type of cancer therapy that uses an antibody to identify a target on cancer cells and deliver a cancer-killing drug directly to them. In this case, the drug targets the HER2 protein, which can drive the growth of certain cancer cells. As a bispecific ADC, it is engineered to bind to two separate sites on the HER2 protein, known as the ECD II and ECD IV domains, with a drug payload attached through a cleavable linker. The design is intended to work more effectively than existing HER2 antibodies or single-target ADCs, particularly in patients with lower HER2 expression, who currently have fewer treatment options, according to The Financial Express.

The drug is being evaluated for the treatment of HER2-expressing cancers. The most advanced clinical data comes from HER2-low advanced breast cancer, where it has shown encouraging clinical potential, the companies said. In China, regulators have granted TQB2102 three Breakthrough Therapy Designations covering HER2-low and HER2-positive breast cancer, colorectal cancer, and biliary tract cancer, as reported by The Financial Express.

Partnership Benefits and Next Steps

The agreement gives Cipla access to a late-stage oncology asset without requiring it to develop the molecule from scratch, according to CNBC TV18. Under the deal, Cipla will conduct local clinical trials, handle regulatory filings and manage commercialisation in its licensed markets, while CTTQ retains responsibility for manufacturing and supplying TQB2102. The treatment remains under clinical evaluation, meaning its eventual availability in Cipla's licensed markets will depend on further development and regulatory approvals.

Sino Biopharmaceutical Group CEO Eric Tse said, "Expanding global access to medicines developed by SBP Group is a central part of our strategy."

Cipla, founded in 1935 and headquartered in Mumbai, has a US business that relies on subsidiaries like InvaGen Pharmaceuticals, noted The Financial Express. Over the past year, Cipla's share price has been down 0.2%.