Cipla has entered into an exclusive licensing agreement with SBP Group for the HER2 bispecific antibody-drug conjugate (ADC) rolditamig deuderuxtecan (TQB2102), covering India, South Africa, and five other emerging markets. The deal, announced on August 31, 2026, aims to accelerate patient access to this potential best-in-class oncology therapy.

Deal structure and market scope

Under the agreement, Cipla will be responsible for local clinical development, regulatory activities, and commercial sales of rolditamig deuderuxtecan across the licensed territories. The deal spans a total of seven markets, with India and South Africa explicitly named alongside five additional emerging markets. SBP Group’s subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), will continue to manufacture and supply TQB2102.

Key deal parameters

The following table summarises the known parameters of the licensing agreement:

Rolditamig deuderuxtecan, designated TQB2102, is a next-generation HER2 dual-epitope bispecific ADC independently developed by SBP Group. It simultaneously binds to the ECD II and ECD IV domains of HER2 and incorporates a cleavable linker and topoisomerase I inhibitor payload. This differentiated design is intended to overcome limitations associated with conventional HER2 monoclonal antibodies or single-target ADCs, potentially enhancing receptor cross-linking and endocytosis efficiency in patients with HER2-low expression.

Clinical potential and regulatory status

TQB2102 has received three Breakthrough Therapy Designations from the Center for Drug Evaluation of China's National Medical Products Administration. It is currently being evaluated for HER2-low, HER2-positive breast cancer, colorectal cancer, and biliary tract cancer across multiple treatment settings. The asset has demonstrated encouraging clinical potential in HER2-low advanced breast cancer.

Strategic rationale

Achin Gupta, Managing Director and Global Chief Executive Officer of Cipla, stated that the agreement strengthens the company’s oncology portfolio with a promising HER2-targeted antibody-drug conjugate. He noted that breast cancer remains a significant healthcare challenge and that the partnership aims to accelerate development and expand access subject to regulatory approvals.

Eric Tse, CEO of SBP Group, highlighted that expanding global access to medicines is central to their strategy. He cited Cipla’s scale, local expertise, and commitment to patient access as key factors in selecting it as a partner for India, South Africa, and other emerging markets.

Source: https://lodr-files.dhan.co/lodr-inputs/Company/INE059A01026/b5ca36cd-3407-4f2f-9182-8b004f794ce4.pdf

Cipla announced that the United States Food and Drug Administration (USFDA) has classified the inspection of InvaGen Pharmaceuticals Inc.'s Unit 3 facility in New York as Voluntary Action Indicated (VAI).

Regulatory classification details

A VAI classification indicates that while the USFDA may have observed certain observations during the inspection, no regulatory action is recommended by the agency at this stage. This is considered a favourable outcome in the USFDA's post-inspection classification framework.

The key details of the regulatory development are as follows:

Significance of the VAI status

The USFDA assigns one of three classifications following a facility inspection: No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). A VAI status signals that the agency does not intend to pursue regulatory or administrative action against the facility, placing it in a compliant standing with the regulator.

InvaGen Pharmaceuticals Inc. is a subsidiary of Cipla, operating in the United States market. The Unit 3 facility in New York is subject to USFDA oversight as part of standard pharmaceutical manufacturing compliance requirements.