Sichuan Kelun-Biotech Announces NMPA Acceptance of New Indication Application for Core Product sac-TMT (Sacituzumab Tirumotecan)
Key Milestone for First-Line Triple-Negative Breast Cancer Treatment; Multiple Price-Sensitive Developments
Key Points for Investors
- New Indication Application Accepted: The National Medical Products Administration (NMPA) of China has accepted for review a new indication application for Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.’s (Stock Code: 6990) core product, sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870, 佳泰萊®). This is for first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage. This marks the sixth indication application accepted by the NMPA for sac-TMT.
- Clinical Data: The application is based on positive results from the randomized, open-label, multicenter Phase 3 OptiTROP-Breast03 study, which demonstrated statistically significant and clinically meaningful improvements in efficacy compared with investigator’s choice of chemotherapy.
- Regulatory Advantage: The new indication has been included in the NMPA’s priority review and approval process, potentially expediting market entry and patient access.
- Breakthrough Therapy Designation (BTD): Sac-TMT had previously received BTD from the NMPA for first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1-negative TNBC. In total, sac-TMT has received six BTDs from the NMPA.
- Multiple Approved Indications: Sac-TMT is already approved and marketed in China for four oncology indications, including advanced TNBC, EGFR mutant-positive non-squamous non-small cell lung cancer (NSCLC) after EGFR-TKI and chemotherapy, and hormone receptor-positive/HER2-negative breast cancer after prior treatment. The first two indications are included in China’s National Reimbursement Drug List (NRDL), expanding patient access and potential sales.
- Innovative ADC Technology: Sac-TMT is a novel TROP2-targeted antibody-drug conjugate (ADC) with a bifunctional linker for optimized drug delivery and bystander effect, using a belotecan-derivative topoisomerase I inhibitor as its payload. It boasts a high drug-to-antibody ratio (DAR) of 7.4.
- Global Commercialization Partnership: In May 2022, Kelun-Biotech licensed exclusive rights to Merck & Co., Inc. (MSD) for development and commercialization outside Greater China. MSD currently sponsors 17 ongoing global Phase 3 studies of sac-TMT across various cancer types, either as a monotherapy or in combination with pembrolizumab (Keytruda®) or other anti-cancer agents.
- Ongoing Clinical Development: Kelun-Biotech has launched 9 registrational clinical studies in China, while MSD leads 17 global studies, highlighting sac-TMT’s strategic importance and commercial potential.
- Upcoming Indication Applications: Two additional NMPA priority reviews are underway: (1) sac-TMT in combination with pembrolizumab for first-line NSCLC with PD-L1 TPS ≥1%, EGFR-negative, and ALK-negative; (2) sac-TMT for first-line recurrent or metastatic TNBC with PD-L1 CPS <10 or with prior PD-1/PD-L1 inhibitor therapy.
- Market Leadership: Sac-TMT is the world’s first TROP2 ADC approved for lung cancer.
Price-Sensitive Information for Shareholders
- Potential for Expanded Market: Acceptance into priority review and the possibility of a new first-line TNBC indication could significantly increase sac-TMT’s addressable market and revenue potential.
- Strategic Reimbursement Inclusion: Current inclusion of sac-TMT in the NRDL for two indications already boosts accessibility and sales in China—further reimbursement expansion would be a catalyst.
- Global Partnership: The ongoing MSD-led global Phase 3 programs could lead to regulatory approvals and commercialization outside China, triggering milestone payments and royalties for Kelun-Biotech.
- Regulatory and Development Risks: Shareholders should note that the new indications are not yet approved and may not ultimately be commercialized. Any setbacks in clinical development or regulatory review could adversely impact share value.
Full Article Summary
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX: 6990) has announced that its new indication application for sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870, 佳泰萊®), a core TROP2-targeted ADC product, was accepted by the NMPA for review. This application seeks approval for first-line treatment of recurrent or metastatic TNBC patients with PD-L1 CPS <10, or those who have recurred after prior PD-1/PD-L1 inhibitor therapy. This is the sixth indication application for sac-TMT in China.
The new application leverages robust data from the pivotal Phase 3 OptiTROP-Breast03 study, which demonstrated statistically significant and clinically meaningful improvements in efficacy for sac-TMT versus standard chemotherapy. This success aligns with sac-TMT’s previous receipt of Breakthrough Therapy Designation and its inclusion in the NMPA’s priority review process, which may shorten the timeline for regulatory approval and patient access.
Sac-TMT, an innovative ADC, is engineered for targeted delivery and potent anti-tumor effects, with a unique bifunctional linker and a high drug-to-antibody ratio. The agent is currently approved in China for four major indications across breast and lung cancers—two of which are reimbursed nationally. This product is also the world’s first TROP2 ADC approved in lung cancer.
On the global stage, Kelun-Biotech has out-licensed sac-TMT to Merck (MSD) for territories outside Greater China, with 17 global Phase 3 studies currently underway. The company itself is running 9 registrational clinical trials in China. The collaboration with Merck offers substantial upside potential from licensing fees, milestone payments, and possible royalties.
Two further NMPA priority review applications are ongoing, including sac-TMT in combination with pembrolizumab for select NSCLC patients—a combination that may further extend the product’s reach and impact in the oncology market.
Shareholder Warning: While sac-TMT has demonstrated significant clinical benefit, there are inherent risks associated with drug development and regulatory processes. Not all pipeline indications may eventually reach commercialization, and setbacks could affect the company’s valuation.
Disclaimer
This article is for informational purposes only and does not constitute investment advice. All investments carry risk. Investors should conduct their own due diligence and consult professional advisors before making investment decisions. The company’s forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
