Hutchmed and Innovent Biologics Announce New Drug Application Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 21 2026
0mins
Hutchmed and Innovent Biologics jointly announce that the New Drug Application for the combination of Elunate and Tyvyt has been granted approval by the China National Medical Products Administration for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors therapy and have not received programmed death receptor-1 or programmed death-ligand 1 inhibitor therapy in the first-line setting.
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About HCM
HUTCHMED (China) Ltd is an investment holding company principally engaged in the manufacture and sale of pharmaceuticals. The Company operates its business through two segments. Oncology Immunology segment is engaged in the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Among it, research and development (R&D) includes research and development activities covering drug discovery, development, manufacturing and regulatory functions, out-licensing of in-house developed drugs, as well as administrative activities to support research and development operations, marketed products comprises the invoiced sales, marketing, manufacture and distribution of drugs developed from research and development activities. Other Ventures segment is engaged in the other commercial businesses which include the sales, marketing, manufacture and distribution of other prescription drugs and healthcare products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
HUTCHMED to Present New Data at ASCO Meeting
- Key Study Results: HUTCHMED will present pivotal Phase II study results of savolitinib at the 2026 ASCO Annual Meeting, demonstrating a 32.3% objective response rate in MET-amplified gastric cancer patients in China, exceeding the pre-specified efficacy threshold and highlighting the drug's potential in treatment.
- Clinical Data Support: As of the October 8, 2025 data cut-off, savolitinib showed a disease control rate of 63.1%, a median time to response of 1.4 months, and a median duration of response of 9.7 months, providing strong support for the New Drug Application submission to the China National Medical Products Administration.
- Diverse Study Presentations: HUTCHMED will also showcase results from various studies of fruquintinib across multiple tumor indications, including the FRESCO and FRUSICA series, further validating its efficacy and safety in different cancer types.
- Strategic Implications: This data presentation not only enhances HUTCHMED's influence in the global oncology treatment landscape but may also accelerate market access for its products, strengthening the company's position in the competitive biopharmaceutical market.
See More
HUTCHMED and Innovent's Drug Combination Approved in China
- Drug Combination Approved: The combination of ELUNATE and TYVYT developed by HUTCHMED and Innovent has received approval from the China National Medical Products Administration for patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy, marking a significant advancement in RCC treatment in China.
- Clinical Trial Data Support: The Phase 3 FRUSICA-2 trial demonstrated a 63% reduction in the risk of disease progression or death with the combination therapy compared to monotherapy, with a median progression-free survival of 22.2 months versus 6.9 months for the control group, indicating strong clinical applicability.
- Significant Efficacy: The combination achieved an objective response rate of 60.5%, significantly higher than the control group's 24.3%, with a median duration of response of 23.7 months, showcasing consistent efficacy across various IMDC prognostic risk groups and reinforcing its therapeutic position.
- Market Impact: This approval marks the tenth indication for TYVYT in China, highlighting its role as a widely used PD-1 inhibitor in the oncology landscape and providing new treatment options for patients, addressing the urgent need for second-line therapies.
See More
HUTCHMED and Innovent Jointly Approved New Drug
- NDA Approval: The New Drug Application for the combination of ELUNATE® and TYVYT® by HUTCHMED and Innovent has been approved by the NMPA, providing new hope for patients with advanced renal cell carcinoma.
- Clinical Trial Results: The FRUSICA-2 study demonstrated a median progression-free survival (PFS) of 22.2 months for the combination therapy, significantly outperforming the control group's 6.9 months, indicating its efficacy and potential in second-line treatment.
- Market Demand Response: This approval addresses the urgent need for effective treatment options for advanced renal cell carcinoma patients in China, with HUTCHMED committed to advancing innovative therapies to meet market demands.
- Strategic Implications: This approval not only recognizes the efforts of HUTCHMED and Innovent in cancer treatment but also lays the groundwork for future clinical research and market expansion, further solidifying both companies' positions in the biopharmaceutical industry.
See More
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- Ongoing Availability: All company presentations will be accessible 24/7 for the next 90 days, meeting investors' needs for flexibility while providing companies with ongoing opportunities to showcase their business.
- Enhanced Investor Relations: Virtual Investor Conferences facilitate real-time investor engagement solutions, enabling companies to connect with investors more efficiently, thereby improving the effectiveness of investor relations management.
See More
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- Participation Fee: The conference is free for participants, with pre-registration suggested, reflecting Deutsche Bank's commitment to providing convenient services for investors and further solidifying its leadership in investor relations management.
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HUTCHMED to Present New Data on HMPL-A580 at AACR 2026
- HMPL-A580 Clinical Data Presentation: HUTCHMED will present new clinical data on HMPL-A580, a first-in-class PI3K/PIKK-EGFR antibody-targeted therapy conjugate, at the AACR 2026 Annual Meeting, demonstrating potent inhibition of PI3K and PIKK kinases with IC50 values ranging from 1 to 10 nM, indicating its potential in cancer treatment.
- Significant Anti-Tumor Effects: HMPL-A580 exhibited robust anti-tumor effects across 38 human solid tumor cell lines, particularly showing heightened sensitivity in EGFR high-expressing, EGFR-mutated, or PAM-altered tumor cells, highlighting its application prospects in precision medicine.
- Dose-Dependent Efficacy: In human tumor xenograft models in mice, HMPL-A580 demonstrated dose/exposure-dependent anti-tumor activity when administered intravenously at 1-10 mg/kg once weekly for two weeks, indicating significant target inhibition across multiple EGFR-expression models.
- Innovative ATTC Platform: HUTCHMED's ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with small-molecule inhibitors to overcome the limitations of traditional antibody-drug conjugates, aiming for more durable anti-tumor responses and improved safety profiles.
See More
HUTCHMED to Present New Data at ASCO Meeting
- Key Study Results: HUTCHMED will present pivotal Phase II study results of savolitinib at the 2026 ASCO Annual Meeting, demonstrating a 32.3% objective response rate in MET-amplified gastric cancer patients in China, exceeding the pre-specified efficacy threshold and highlighting the drug's potential in treatment.
- Clinical Data Support: As of the October 8, 2025 data cut-off, savolitinib showed a disease control rate of 63.1%, a median time to response of 1.4 months, and a median duration of response of 9.7 months, providing strong support for the New Drug Application submission to the China National Medical Products Administration.
- Diverse Study Presentations: HUTCHMED will also showcase results from various studies of fruquintinib across multiple tumor indications, including the FRESCO and FRUSICA series, further validating its efficacy and safety in different cancer types.
- Strategic Implications: This data presentation not only enhances HUTCHMED's influence in the global oncology treatment landscape but may also accelerate market access for its products, strengthening the company's position in the competitive biopharmaceutical market.
See More
HUTCHMED and Innovent's Drug Combination Approved in China
- Drug Combination Approved: The combination of ELUNATE and TYVYT developed by HUTCHMED and Innovent has received approval from the China National Medical Products Administration for patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy, marking a significant advancement in RCC treatment in China.
- Clinical Trial Data Support: The Phase 3 FRUSICA-2 trial demonstrated a 63% reduction in the risk of disease progression or death with the combination therapy compared to monotherapy, with a median progression-free survival of 22.2 months versus 6.9 months for the control group, indicating strong clinical applicability.
- Significant Efficacy: The combination achieved an objective response rate of 60.5%, significantly higher than the control group's 24.3%, with a median duration of response of 23.7 months, showcasing consistent efficacy across various IMDC prognostic risk groups and reinforcing its therapeutic position.
- Market Impact: This approval marks the tenth indication for TYVYT in China, highlighting its role as a widely used PD-1 inhibitor in the oncology landscape and providing new treatment options for patients, addressing the urgent need for second-line therapies.
See More
HUTCHMED and Innovent Jointly Approved New Drug
- NDA Approval: The New Drug Application for the combination of ELUNATE® and TYVYT® by HUTCHMED and Innovent has been approved by the NMPA, providing new hope for patients with advanced renal cell carcinoma.
- Clinical Trial Results: The FRUSICA-2 study demonstrated a median progression-free survival (PFS) of 22.2 months for the combination therapy, significantly outperforming the control group's 6.9 months, indicating its efficacy and potential in second-line treatment.
- Market Demand Response: This approval addresses the urgent need for effective treatment options for advanced renal cell carcinoma patients in China, with HUTCHMED committed to advancing innovative therapies to meet market demands.
- Strategic Implications: This approval not only recognizes the efforts of HUTCHMED and Innovent in cancer treatment but also lays the groundwork for future clinical research and market expansion, further solidifying both companies' positions in the biopharmaceutical industry.
See More
Virtual Investor Conference Presentations Now Available Online
- Conference Content Release: Presentations from the Depositary Receipts Virtual Investor Conference (dbVIC) held on April 28, 2026, are now available for online viewing, enhancing accessibility and transparency of information for investors.
- Investor Material Downloads: Investors can download materials from participating companies such as Lotus Technology and Viomi Technology, which fosters improved interaction and communication between investors and companies.
- Ongoing Availability: All company presentations will be accessible 24/7 for the next 90 days, meeting investors' needs for flexibility while providing companies with ongoing opportunities to showcase their business.
- Enhanced Investor Relations: Virtual Investor Conferences facilitate real-time investor engagement solutions, enabling companies to connect with investors more efficiently, thereby improving the effectiveness of investor relations management.
See More
Deutsche Bank to Host Depositary Receipts Investor Conference
- Conference Details: Deutsche Bank is set to host the Depositary Receipts Virtual Investor Conference on April 28, 2026, featuring live presentations from international companies based in Australia, China, Hong Kong, Portugal, Netherlands, Cayman Islands, and France, aimed at attracting a diverse range of investors and analysts.
- Participating Companies: The agenda includes presentations from Lotus Technology Inc., Viomi Technology Co., Ltd, and Belite Bio, Inc., showcasing Deutsche Bank's expertise in managing cross-border equity structures, which is expected to enhance its influence in the global market.
- Participation Fee: The conference is free for participants, with pre-registration suggested, reflecting Deutsche Bank's commitment to providing convenient services for investors and further solidifying its leadership in investor relations management.
- Service Range: Deutsche Bank specializes not only in the administration of depositary receipts but also offers a wide array of financial services, including complex securitizations, project financing, and debt restructuring, demonstrating its comprehensive strength in the global financial services market.
See More
HUTCHMED to Present New Data on HMPL-A580 at AACR 2026
- HMPL-A580 Clinical Data Presentation: HUTCHMED will present new clinical data on HMPL-A580, a first-in-class PI3K/PIKK-EGFR antibody-targeted therapy conjugate, at the AACR 2026 Annual Meeting, demonstrating potent inhibition of PI3K and PIKK kinases with IC50 values ranging from 1 to 10 nM, indicating its potential in cancer treatment.
- Significant Anti-Tumor Effects: HMPL-A580 exhibited robust anti-tumor effects across 38 human solid tumor cell lines, particularly showing heightened sensitivity in EGFR high-expressing, EGFR-mutated, or PAM-altered tumor cells, highlighting its application prospects in precision medicine.
- Dose-Dependent Efficacy: In human tumor xenograft models in mice, HMPL-A580 demonstrated dose/exposure-dependent anti-tumor activity when administered intravenously at 1-10 mg/kg once weekly for two weeks, indicating significant target inhibition across multiple EGFR-expression models.
- Innovative ATTC Platform: HUTCHMED's ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with small-molecule inhibitors to overcome the limitations of traditional antibody-drug conjugates, aiming for more durable anti-tumor responses and improved safety profiles.
See More
