Hansoh Pharma Achieves Dual Breakthroughs: B7-H3 ADC HS-20093 for Prostate Cancer Granted Priority Review, Insomnia Drug HS-10506 Shows Promising Phase II Data
Hansoh Pharma
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On April 21, the CDE official website showed,Hansoh PharmaTheHS-20093 for InjectionAnother indication has been included in the breakthrough therapy public announcement list for advanced castration-resistant prostate cancer that has previously undergone novel endocrine therapy and taxane-based chemotherapy. As the fastest-progressing domestically produced B7-H3 ADC, the drug has entered Phase III clinical trials and has previously received breakthrough therapy designations for multiple solid tumor indications.
Screenshot source: CDE official website
On the same day,Hansoh PharmaOX2R Antagonist Presented at the 2026 American Academy of Neurology (AAN) Annual MeetingHS-10506Positive Data from Phase 1b/2 Study for Insomnia Treatment Show Significant Efficacy in Improving Sleep Onset and Maintenance with Good Safety, Laying Foundation for Upcoming Phase 3 Clinical Trial.
On one side, the heavy-duty ADC in the oncology track continues to broaden the boundaries of indications; on the other side, innovative drugs in the neurology field show outstanding clinical results.The two products respectively represent Hansoh Pharma's key advancements in the two core fields of oncology ADC and sleep disorder novel drugs.
01
Racing to the Forefront of China's B7-H3 ADCs, Targeting Advanced Prostate Cancer
HS-20093YesHansoh PharmaAn independently developed antibody-drug conjugate targeting B7-H3, composed of a fully human B7-H3 monoclonal antibody and a topoisomerase inhibitor.（TOPOi）The effective payload is covalently linked. The drug has long since gone global: In December 2023, GSK (GlaxoSmithKline).（GSK）Gained its exclusive rights in global markets outside of Greater China, with the R&D code GSK5764227.
Data from More Entropy shows that previously,HS-20093Multiple indications have been included in the breakthrough therapy by the CDE, including extensive-stage small cell lung cancer that has progressed after standard first-line treatment, osteosarcoma patients who have progressed after at least two lines of treatment, and locally advanced or metastatic non-squamous non-small cell lung cancer.
Screenshot source: Global Drug R&D Database(More clicksMini ProgramView)
Currently, the incidence of prostate cancer in China is on the rise, and treatment options for later-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) are limited, representing a clear unmet clinical need. B7-H3 is highly expressed in various solid tumors, including prostate cancer, and has become a promising therapeutic target.HS-20093With its fully human antibody design and highly potent TOPOi payload, it is expected to enhance anti-tumor activity while improving safety profiles.
The newly added indication for prostate cancer further expandsHS-20093The layout in the field of urological tumors also provides new potential treatment options for patients with late-stage castration-resistant prostate cancer. As multiple Phase III clinical trials of this drug are underway, the B7-H3 ADC track in China is gradually entering a critical harvest period.
02
Positive Phase II Results for New Insomnia Drug, Sleep Latency Reduced by Nearly 19 Minutes at Most
In the field of neurotherapy,Hansoh PharmaSelective Orexin-2 Receptor（OX2R）AntagonistHS-10506Similarly achieved a phased breakthrough.
HS-10506Is aHighly Selective Orexin-2 Receptor（OX2R）AntagonistThe orexin system plays a key role in maintaining wakefulness. This product improves insomnia symptoms by blocking OX2R signaling and suppressing excessive wakefulness.
This time at the 2026 American Academy of Neurology（AAN）The annual meeting announced a multicenter, randomized, double-blind, placebo-controlled phase 1b/2 clinical study aimed at evaluatingHS-10506Efficacy and Safety in Patients with Insomnia.
Source of the screenshot: Global Drug R&D Database(More clicksMini ProgramView）
Study Design：
Phase Ib is the multi-dose escalation stage, during which patients received doses of 10 mg, 20 mg, 40 mg, and 80 mg respectively.HS-10506Or placebo.
In Phase II, patients were randomly assigned to receive 20 mg, 40 mg, or 60 mg.HS-10506Or placebo, once daily for 28 days. The primary endpoint was the sustained sleep latency on Days 13/14.（LPS）Change from baseline.
Key Results：
Significant efficacy: Compared with placebo, the LPS levels in the 20 mg, 40 mg, and 60 mg dose groups(D13/14)Respectively shorten13.7 minutes, 16.6 minutes, 18.8 minutes, and the differences are statistically and clinically significant.
Well Tolerated and Safe: All dose groups showed good safety, with no adverse effects observed on daytime alertness, cognitive function, mood, etc., andNo rebound insomnia occurred。
Support Phase III Advancement: The results are consistent with the trends previously reported at the ECNP conference, providingHS-10506Laid a solid foundation for entering Phase III clinical trials.
WithHS-20093Various indications are gradually being pushed to market, andHS-10506Entered Phase 3 Clinical Trials,Hansoh PharmaIt is expected to see a wave of result materializations in the next 2-3 years. As competition in China's innovative drug market becomes increasingly fierce, this "oncology + neuroscience" dual-engine advancement strategy may become a key pivot for maintaining its R&D competitiveness.
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