Hansoh HS-10541 NMPA trial nod for KRAS G12C

Key Takeaways

• Hansoh disclosed NMPA Clinical Trial Approval for HS-10541 tablets in KRAS G12C-mutated advanced solid tumors on 13 May 2026.
• NCT07615413 is a multicenter, open-label Phase 1 of oral once-daily HS-10541 ± other anti-cancer therapies; status not yet recruiting.
• Primary endpoints include dose-limiting toxicity, adverse events, ORR, and PFS; estimated enrollment is 636 participants.
• This is trial authorization, not marketing approval—no efficacy readout is in the primary disclosures cited here.

HS-10541 at a glance

Field	Detail
Company	Hansoh Pharmaceutical Group (HKEX: 3692) / Jiangsu Hansoh Pharmaceutical
Asset	HS-10541 tablets (Class 1 innovative drug, self-developed)
Indication (CTA)	KRAS G12C-mutated advanced solid tumors
Regulator step	NMPA Clinical Trial Approval (China), announced 13 May 2026
Registry ID	NCT07615413 (Phase 1; not yet recruiting)
Dosing (registry)	Oral, once daily, continuous regimen
Est. timeline	Start 30 Jun 2026; primary completion 30 Jun 2029; completion 30 Dec 2029

What did Hansoh’s HKEX filing say?

In its 13 May 2026 HKEX voluntary announcement on HS-10541 tablets, Hansoh Pharmaceutical Group Company Limited said the National Medical Products Administration of China issued a Clinical Trial Approval for the self-developed Class 1 innovative drug. The intended investigation is “treatment of patients with KRAS G12C-mutated advanced solid tumors.”

The filing is a regulatory green light to begin clinical investigation in China under that CTA, not a claim of clinical activity or commercial launch. Readers should separate CTA language from later Phase 1 safety/PK or registrational packages.

How is NCT07615413 designed?

ClinicalTrials.gov record NCT07615413 titles the program as a Phase I study evaluating safety, tolerability, pharmacokinetics, and efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.

The registry lists Jiangsu Hansoh Pharmaceutical Co., Ltd. as lead sponsor, study type interventional, phase Phase 1, allocation N/A, single-group intervention model, and primary purpose treatment. Estimated enrollment is 636. Status is not yet recruiting, with study start dated 30 June 2026, primary completion 30 June 2029, and study completion 30 December 2029.

Intervention text states HS-10541 will be administered orally once daily in a continuous regimen. Primary outcomes include dose-limiting toxicity in Cycle 1 (21-day cycle), treatment-emergent and serious adverse events, objective response rate by RECIST 1.1, and progression-free survival. Secondary measures include PK parameters (Cmax, Tmax, AUC), disease control rate, and duration of response.

Where does KRAS G12C fit in the approved landscape?

KRAS G12C is already a validated oncology target with approved agents in other jurisdictions. For example, FDA’s page on approval of sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer documents a U.S. regulatory pathway for G12C-directed therapy in a solid-tumor setting. That precedent explains why China innovators continue to file CTAs for next G12C candidates; it does not mean HS-10541 has shown comparable benefit.

Hansoh’s disclosure does not state whether HS-10541 is covalent, reversible, or combination-optimized versus first-generation G12C inhibitors. Until Protocol details and dose-escalation data appear, mechanism claims beyond “investigated in KRAS G12C-mutated advanced solid tumors” should be avoided.

What should APAC trial planners watch next?

Watch for first-patient-in updates that move NCT07615413 from not yet recruiting to recruiting, China site lists, and any combination cohorts named on the registry. China first-in-human G12C programs often later seek multi-regional expansion; the current primary package only supports China CTA plus the global registry listing.

For competitive context inside NovaPharmaNews APAC coverage, see the Insilico–Bora AI development alliance, Nektar pipeline and trial context, and TGA Australia pharmaceutical approval notes.

What remains unproven?

No primary source cited here reports ORR, PFS, dose, or safety rates for HS-10541 in humans. The NMPA action authorizes clinical investigation; NCT07615413’s estimated enrollment and dates can change. Combination partners named as “other anti-cancer therapies” are not specified in the registry summary excerpted for this report. Do not treat the CTA as evidence of superiority to approved G12C drugs.

Frequently Asked Questions

Primary Sources

1. HKEX: Hansoh voluntary announcement — HS-10541 NMPA Clinical Trial Approval (13 May 2026)
2. ClinicalTrials.gov: NCT07615413 — Phase 1 study of HS-10541 in KRAS G12C solid tumors
3. FDA: Approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer