Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that the National Medical Products Administration (NMPA) has granted approval for a fourth indication for Jiatailai (sacituzumab tirumotecan), its TROP2-targeted antibody-drug conjugate (ADC). The new authorization covers adult patients with unresectable or metastatic HR+/HER2- breast cancer who have progressed after prior endocrine therapy and chemotherapy, significantly expanding the drug’s addressable oncology market.
Regulatory Milestone
Item
Detail
Company
Sichuan Kelun-Biotech (6990.HK)
Agency
NMPA (China)
Asset
Jiatailai (sacituzumab tirumotecan) – TROP2 ADC
New Indication
HR+/HER2- breast cancer (post-endocrine, post-chemo)
Approval Basis
Phase III OptiTROP-Breast02 study
Total Indications
Four (2 NSCLC + 1 TNBC + 1 HR+/HER2- BC)
Clinical Evidence – OptiTROP-Breast02 Study
Endpoint
Jiatailai
Investigator’s Choice Chemotherapy
Clinical Benefit
Median PFS (BICR-assessed)
8.3 months
4.1 months
102% improvement
Subgroup Consistency
PFS benefit across all pre-specified subgroups
–
Broad applicability
Study Design: Phase III, randomized, Jiatailai monotherapy vs. investigator’s choice chemotherapy in unresectable/metastatic HR+/HER2- breast cancer
Approved Indication Portfolio
Indication
Patient Population
Approval Status
Non-small cell lung cancer (NSCLC)
Specific subpopulations
Approved (2 indications)
Triple-negative breast cancer (TNBC)
Advanced/metastatic
Approved
HR+/HER2- breast cancer
Post-endocrine, post-chemo
Newly approved (4th indication)
Global Partnership & Commercial Positioning
MSD Licensing Deal: In May 2022, Merck Sharp & Dohme (MSD) secured rights to Jiatailai for territories outside Greater China, validating the asset’s global commercial potential and providing Kelun-Biotech with upfront and milestone payments plus royalties.
TROP2 ADC Competitive Landscape: Jiatailai joins datopotamab deruxtecan (Dato-DXd, AstraZeneca/Daiichi) and sacituzumab govitecan (Trodelvy, Gilead) in the HR+/HER2- breast cancer space, with differentiation potential through its tirumotecan payload and Chinese market priority position.
China Market Access: HR+/HER2- breast cancer represents the largest breast cancer subtype in China; approval positions Jiatailai for national reimbursement drug list (NRDL) negotiation and volume-based procurement participation.
Strategic Outlook
Priority
Execution Plan
NRDL Inclusion
Pursue 2026 NRDL listing for HR+/HER2- indication to maximize access
Global Development
Support MSD’s ex-China regulatory submissions and commercialization
Pipeline Expansion
Leverage TROP2 platform for additional tumor types (e.g., gastric, bladder)
Combination Studies
Explore Jiatailai + immunotherapy or endocrine therapy combinations
Forward‑Looking Statements This brief contains forward‑looking statements regarding Jiatailai commercial performance in HR+/HER2- breast cancer, NRDL negotiation outcomes, and MSD partnership milestones. Actual results may differ due to competitive dynamics in the TROP2 ADC market, reimbursement pricing pressures, and global regulatory review timelines.-Fineline Info & Tech
By Fineline Cube 