Sino Biopharmaceutical (HKG: 1177) announced that Culmerciclib Capsules, the world’s first CDK2/4/6 inhibitor, received marketing approval from China’s National Medical Products Administration (NMPA) for use with fulvestrant in HR+/HER2‑ locally advanced or metastatic breast cancer patients previously treated with endocrine therapy.
Regulatory Milestone
Item
Details
Approval Date
11 Dec 2025
Product
Culmerciclib Capsules (oral)
Company
Sino Biopharmaceutical (1177.HK)
Indication
HR+/HER2‑ locally advanced or metastatic breast cancer (post‑endocrine therapy)
Combination
With fulvestrant injection
Innovation
World’s first CDK2/4/6 inhibitor (self‑developed Category 1 drug)
Launch Timeline
Q1 2026 (hospital channel)
Drug Profile & Mechanism
Attribute
Culmerciclib
Competitive Context
Targets
CDK2, CDK4, CDK6 kinases
Expands beyond CDK4/6 class (palbociclib, ribociclib, abemaciclib)
Selectivity
Strong preferential inhibition of CDK4
Designed to delay resistance to existing CDK4/6 inhibitors
Advantage
Expected to alleviate bone marrow suppression vs. current agents
Addresses key toxicity limiting long‑term use
Administration
Oral capsules, QD dosing
Patient‑convenient; aligns with endocrine therapy schedule
Second Filing
Marketing application submitted July 2025 for initial endocrine treatment setting
Broader label expansion pending
Clinical Evidence – CULMINATE‑2 Study (ESMO 2025)
Endpoint
Culmerciclib + Fulvestrant
Placebo + Fulvestrant
Statistical Significance
Median PFS (mPFS)
Not Reached (NR)
20.2 months
HR = 0.56, p = 0.0004
Risk Reduction
44% reduction in disease progression/death
—
Highly significant
Objective Response Rate (ORR)
59.3%
42.3%
p = 0.0009
High‑Risk Subgroups
Significant PFS benefit in visceral metastasis and liver metastasis
—
Demonstrates efficacy in hard‑to‑treat populations
Dominated by imported agents; price pressure from NRDL
Culmerciclib Peak Sales Forecast
¥3‑4 billion (≈ US$420‑560 M) by 2030
Captures 15‑20% share with differentiation on safety and resistance profile
Reimbursement Strategy
Target NRDL inclusion by 2027 with 20‑30% discount to imported CDK4/6 inhibitors
Accelerates hospital adoption and patient access
Strategic Implications
For Sino Biopharm: Bolsters oncology portfolio (4th innovative drug approved in 2025); validates internal R&D engine capable of producing first‑in‑class molecules; potential for global out‑licensing of CDK2/4/6 platform.
For Physicians: Offers new option for endocrine‑resistant patients with more favorable hematologic safety profile; quarterly monitoring may be reduced vs. existing agents.
For Patients:Oral convenience and potentially longer treatment duration before resistance; subgroup data suggest benefit in aggressive disease (liver mets).
Forward‑Looking Statements This brief contains forward‑looking statements regarding Culmerciclib’s launch timeline, market share projections, and the outcome of the initial endocrine therapy NDA. Actual results may differ due to competitive responses, pricing negotiations, and adoption rates among oncologists.-Fineline Info & Tech
By Fineline Cube 