By Fineline Cube 
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of China‑listed Sino Biopharmaceutical Ltd. (HKG: 1177), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its bispecific antibody‑drug conjugate (ADC) TQB2102 for Injection. The designation applies to patients with HER2 IHC 3+ advanced colorectal cancer who have progressed after standard platinum‑based chemotherapy (oxaliplatin, irinotecan) and fluoropyrimidine regimens. TQB2102 has now entered the Breakthrough Therapy program for a second time, following a July 2025 designation for HER2‑positive breast cancer.
Key Highlights
| Item | Detail |
|---|---|
| Drug | TQB2102 (bispecific ADC) |
| Indication | HER2 IHC 3+ advanced colorectal cancer, post‑oxaliplatin/irinotecan/fluoropyrimidine |
| Designation | FDA Breakthrough Therapy |
| Previous Breakthrough | HER2‑positive breast cancer (July 2025) |
| Mechanism | Dual‑epitope targeting (ECD2 + ECD4) via trastuzumab‑ and pertuzumab‑derived bispecific antibody |
Product Overview
- Bispecific Design – TQB2102 combines the antigen‑binding domains of trastuzumab and pertuzumab into a single antibody scaffold, enabling simultaneous engagement of two non‑overlapping HER2 epitopes (ECD2 & ECD4).
- ADC Payload – Conjugated to a potent cytotoxic payload that is released intracellularly upon HER2‑mediated internalization, maximizing tumor cell killing while sparing normal tissue.
- Clinical Advantage – Preclinical models demonstrate a ~4‑fold increase in tumor‑cell cytotoxicity versus monospecific HER2 ADCs, attributable to enhanced avidity and cross‑linking of HER2 receptors.
Clinical Context
- HER2‑Positive Colorectal Cancer – A rare but aggressive subset (~2–3 % of CRC cases) with limited therapeutic options after failure of first‑line chemotherapy.
- Unmet Need – Existing HER2‑targeted therapies (e.g., trastuzumab, pertuzumab) have modest efficacy in CRC; TQB2102’s bispecific architecture offers a novel mechanism to overcome resistance.
Strategic Implications
- Accelerated Development – Breakthrough Therapy designation unlocks priority review, rolling submissions, and potential for expedited FDA review, shortening time to market.
- Portfolio Expansion – Adds a second indication to TQB2102’s pipeline, reinforcing CTTQ’s focus on HER2‑targeted oncology therapeutics.
- Commercial Potential – With an estimated global market of > $10 billion for HER2‑positive solid tumors, TQB2102 could capture a sizable share of the colorectal cancer segment.
About Sino Biopharma & CTTQ
- Sino Biopharma Ltd. (HKG: 1177) is a leading Chinese biopharmaceutical company engaged in the discovery, development, and commercialization of innovative oncology and immunology products.
- CTTQ is a wholly‑owned subsidiary specializing in antibody‑drug conjugate development, with a robust pipeline of bispecific ADC candidates across multiple tumor types.-Fineline Info & Tech