Sihuan Pharmaceutical Announces Promising Preliminary Phase 1b Data for NG-350A in Rectal Cancer at 2026 AACR

Hong Kong, 20 April 2026 – Sihuan Pharmaceutical Holdings Group Ltd. (Stock Code: 0460) has released a voluntary announcement that could have significant implications for its share value and future growth prospects. The company has presented preliminary results from the Phase 1b FORTRESS clinical study of NG-350A, an oncolytic immunotherapy, at the 2026 Annual Meeting of the American Association for Cancer Research (AACR).

Key Highlights from the Announcement

• Breakthrough Clinical Data: The Phase 1b FORTRESS study, conducted in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), demonstrated a 50% composite response rate (clinical complete response + near clinical complete response) in the first 10 patients who completed a 12-week treatment period. This is a significant improvement compared to the historical benchmark of 25% for chemoradiotherapy (CRT) alone.
• Favorable Safety Profile: There were no serious adverse events or new safety signals related to NG-350A reported in the study, highlighting a positive risk-benefit profile at this stage.
• Innovative Therapy: NG-350A is a novel, intravenously administered Tumor-Specific Immuno-Gene (T-SIGn^®) therapy designed to drive the expression of a CD40 agonist monoclonal antibody within tumors, activating antigen-presenting cells and recruiting T cells to mount a strong anti-tumor response.
• Strategic In-Licensing: The asset was in-licensed by Xuanzhu Biopharmaceutical Co., Ltd. (stock code: 02575.HK), a non-wholly-owned subsidiary of Sihuan Pharmaceutical, from Akamis Bio, Inc., a U.S.-based clinical-stage oncology company.
• Exclusive Rights in Greater China: Xuanzhu Biopharm holds exclusive development, manufacturing, and commercialization rights to NG-350A in Greater China. The company is actively advancing regulatory submissions for clinical trials in the People’s Republic of China.

Potential Price-Sensitive Information for Shareholders

• Significant Efficacy Signal: Early-phase results showing a doubling of the composite response rate versus historical controls could position NG-350A as a potential game-changer in the treatment of pMMR LARC, which historically responds poorly to immunotherapy.
• Pipeline Synergy and Market Potential: If subsequent studies confirm these findings, NG-350A could become a key component in Sihuan’s and Xuanzhu’s oncology portfolios, supporting expansion into the large colorectal cancer market in China and beyond.
• Favorable Safety: The absence of serious safety signals reduces development risk and increases the probability of regulatory success, which can have a direct impact on investor sentiment and valuation.
• Near-term Catalysts: Ongoing clinical development and regulatory milestones in China could provide further price-moving news flow in the coming quarters.

About the Companies Involved

Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001 and listed in 2010, Sihuan Pharmaceutical is a leading Chinese medical aesthetics and pharmaceutical company with a broad product pipeline and strategic focus on innovation. It is leveraging independent R&D platforms in both small molecule and large molecule biopharmaceuticals, aiming to become a leading player in China’s medical aesthetics and biopharmaceutical markets.

Xuanzhu Biopharm

Listed on the Hong Kong Stock Exchange in October 2025 (stock code: 02575.HK), Xuanzhu Biopharm is an innovative pharmaceutical company focused on major diseases including oncology. It holds exclusive rights to NG-350A in Greater China and is actively progressing the regulatory path for this asset.

Akamis Bio, Inc.

Akamis Bio, headquartered in Cambridge, Massachusetts, is a clinical-stage oncology company developing systemically administered oncolytic immunotherapies for colorectal cancer. Its proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn^®) platform underpins NG-350A.

What Should Investors Watch For?

• Further Clinical Updates: Additional data from the FORTRESS trial and subsequent studies, including larger patient cohorts and longer-term follow-up, will be critical in confirming the early efficacy and safety signals.
• Regulatory Progress in China: Xuanzhu Biopharm’s ongoing efforts to advance NG-350A into clinical trials in China could unlock significant commercial opportunities.
• Potential Partnerships or Alliances: Positive data may attract strategic partners or licensing deals, enhancing shareholder value.

Conclusion

The announcement of preliminary Phase 1b data for NG-350A represents a potentially significant milestone for Sihuan Pharmaceutical and its subsidiaries. The strong early efficacy and safety profile in a challenging patient population, combined with exclusive rights in Greater China and a clear development strategy, could materially impact the company’s valuation and future growth trajectory.

Disclaimer: This article is for informational purposes only and does not constitute investment advice, a recommendation, or an offer to buy or sell any securities. Investors should conduct their own research and consult with professional advisors before making any investment decisions. The information contained herein is based on publicly available sources and company announcements as of the date of publication, and may be subject to change without notice.

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