Strategic Initiative: Exclusive Licensing Agreement for HER2 Bispecific ADC

Cipla Limited has entered into an exclusive license and supply agreement with Sino Biopharmaceutical Limited (SBP Group) through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) for Rolditamig Deuderuxtecan (also known as TQB2102), a potential best-in-class HER2 bispecific antibody-drug conjugate (ADC).

Agreement Structure and Territories

Under the agreement, Cipla receives exclusive rights to develop and commercialize TQB2102 in:

  • India
  • South Africa
  • 5 other emerging markets (specific countries not named)

Responsibilities and Roles

  • Cipla's Responsibilities: Local clinical development, regulatory activities, and commercialization in licensed territories
  • CTTQ's Responsibilities: Continued manufacturing and supply of TQB2102

Product Description: Rolditamig Deuderuxtecan (TQB2102)

TQB2102 is a next-generation HER2 dual-epitope bispecific ADC with the following characteristics:

  • Simultaneously binds to ECD II and ECD IV domains of HER2
  • Incorporates a cleavable linker and topoisomerase I inhibitor payload
  • Differentiated design intended to overcome limitations of conventional HER2 monoclonal antibodies or single-target ADCs
  • Dual-epitope binding mode may enhance receptor cross-linking and endocytosis efficiency
  • Particularly promising for treatment of patients with HER2-low expression

Clinical Development Status

TQB2102 is being evaluated across multiple HER2-expressing cancers:

  • HER2-low advanced breast cancer (has demonstrated encouraging clinical potential)
  • HER2-positive breast cancer
  • Colorectal cancer
  • Biliary tract cancer
  • Multiple treatment settings

Regulatory Recognition

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

Strategic Rationale

The collaboration brings together:

  • SBP Group's differentiated late-stage oncology asset and development/manufacturing capabilities
  • Cipla's established regulatory, medical, market access and commercial presence across India, South Africa, and other emerging markets

Management Commentary

Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla: "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."

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

Expected Outcomes

The partnership is intended to:

  • Accelerate local development and regulatory approvals
  • Enable patient access across licensed countries (subject to applicable approvals)
  • Address unmet patient needs in breast cancer treatment