Hansoh's B7-H3 ADC HS-20093 Nominated for Breakthrough Therapy Designation for the Third Time in China

Apr 10, 2025 10:47 CST Updated 10:47

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

On April 9, the CDE website showed that Hansoh PharmaHS-20093 for Injection Proposed for Inclusion in Breakthrough Therapy Designation, for Use inPreviously progressed or relapsed after platinum-based chemotherapy, driver gene-negative, locally advanced or metastaticNon-squamous Non-small Cell Lung Cancer。

PreviouslyHS-20093 AlreadyIncluded in the breakthrough therapy twice, and if this public announcement is passed, it will become the drug'sThe 3rd Breakthrough Therapy Designation。

Screenshot source: Insight database

HS-20093 is a B7-H3 ADC,Using a clinically validated topoisomerase inhibitor（TOPOi）Payload.

Phase I Clinical TrialARTEMIS-001 (NCT05276609) Data(For the treatment of advanced solid tumors)Presented at the 2023 American Society of Clinical Oncology (ASCO) (ASCO) Announced at the annual meeting. The drug has demonstrated preliminary clinical activity in small cell lung cancer, non-small cell lung cancer, and sarcoma, with multiple responses confirmed and manageable safety.

In December 2023, GSK and Hansoh Pharma reachedExclusive License Agreement, GSK obtains the global exclusive rights to the drug(Excluding mainland China, Hong Kong, Macao and Taiwan), to advance the development and commercialization of HS-20093.

According to the terms of this agreement, Hansoh will obtain$185 millionThe prepayment, and is eligible to receive up to$1.525 billionThe milestone revenue. After the commercialization of HS-20093, GSK will also pay tiered royalties based on global net sales outside of mainland China, Hong Kong, Macao, and Taiwan.

The CDE official website shows that the drug has previouslyTwo indications have received Breakthrough Therapy Designation:

October 2024, after standard first-line treatment(Platinum-based doublet chemotherapy combined with immunotherapy)Later ProgressExtensive-Stage Small Cell Lung Cancer；
February 2025, for the treatment of patients who have progressed after at least two prior lines of therapyOsteosarcomaPatient.

Insight database shows that there are 27 B7-H3 ADCs under research globally.(Only active status is counted), the fastest-progressing has enteredPhase III Clinical Trial, respectivelyYL201（Yilian Biologics、HS-20093(Hansoh)AndIfinatamab deruxtecan(Daiichi Sankyo). The remaining 10 have entered clinical trials, but all are still in the early stages.

Screenshot source: Insight database

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