Latest news with #SimcereZaiming
Yahoo
19-06-2025
- Business
- Yahoo
Simcere Zaiming Announces First Patient Dosed in the US in a Phase 1 Trial of Trispecific Antibody SIM0500 in Patients with Relapsed/Refractory Multiple Myeloma
SHANGHAI, June 18, 2025 /PRNewswire/ -- Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group ( today announced the first US patient has started treatment in the ongoing Phase 1 trial (SIM0500-101, NCT06375044) at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM). SIM0500 (formerly SCR-8572) is a humanized trispecific antibody targeting GPRC5D, BCMA and CD3, developed using Simcere Zaiming's proprietary T-cell engager polyspecific antibody platform. [1] "In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimize outcomes in the RRMM," said Dr. Joshua Richter, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and Principal Investigator. "SIM0500 is designed to bind to two tumor antigens, GPRC5D and BCMA. It has shown strong T-cell cytotoxicity against multiple myeloma cells in preclinical studies," said Prof. Shaji Kumar, M.D. "I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM." "We are quite pleased with the safety and encouraging efficacy results generated to-date in the ongoing dose escalation and look forward to the extension of the SIM0500 Phase 1 trial to the US. This marks an important step forward in Simcere Zaiming's continued commitment to advance new oncology treatments and elevate the standard of care for patients with RRMM," said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming. SIM0500 is being developed in partnership with AbbVie. About SIM0500 SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in existing multiple myeloma treatments. In April 2024, the FDA awarded SIM0500 a Fast Track designation. In January 2025, Simcere Zaiming entered into an agreement with AbbVie granting AbbVie an option to license SIM0500. SIM0500 is an investigational agent that has not been approved by the FDA or any other regulatory authority. About SIM0500-101 Phase 1 study SIM0500 is currently being investigated in a phase 1 clinical trial both in US and in China. Preliminary data suggested a good safety profile, desired pharmacokinetic profile of SIM0500 with encouraging efficacy. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. This press release contains forward-looking statements within the meaning of applicable securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Factors that could cause such differences include, but are not limited to, the inherent uncertainties in clinical development, regulatory approval processes, competitive developments, and other risks detailed in our filings with the Hong Kong Stock Exchange. [1]. FU Y, You S, Wei M, et al.: A novel T cell engager targeting BCMA and GPRC5D showed promising preclinical activity with low toxic risk for multiple myeloma treatment. Cancer Res (2024) 83 (7_Supplement): 1883 Contacts:Simcere ZaimingPR contacts: pr@ contacts: ir@ View original content: SOURCE Simcere Zaiming Sign in to access your portfolio
Reuters
16-06-2025
- Business
- Reuters
NextCure signs up to $745 million deal with China's Simcere to develop cancer drug
June 16 (Reuters) - Drug developer NextCure (NXTC.O), opens new tab said on Monday it had signed a deal worth up to $745 million with China-based drugmaker Simcere Zaiming ( opens new tab to develop a cancer therapy for solid tumors. NextCure said it will gain global rights to the experimental therapy, SIM0505, in all regions except Greater China, where Simcere Zaiming will retain control. Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment and other milestones up to $745 million, as well as tiered royalties up to double digits on net sales outside China, NextCure added. Simcere's SIM0505 belongs to a class of drugs known as antibody-drug conjugates (ADCs), which are more targeted than conventional chemotherapy. These therapies, also known as 'guided missiles', use antibodies to deliver toxic drugs directly to cancer cells, helping to destroy the tumor while leaving healthy cells unharmed. U.S. drugmakers have been licensing drugs from China for potential new medicines at an accelerating pace, as they look to rebuild pipelines of future products while facing a patent cliff for the older drugs. The experimental cancer drug is currently being tested in an early-stage trial in China. Initial data from the trial is expected in the first half of next year. The company expects to begin studying the drug in the U.S. in the third quarter of 2025.
Yahoo
16-06-2025
- Business
- Yahoo
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025 Initial Phase 1 clinical data is expected in the first half of 2026 NextCure also gains rights to Simcere Zaiming's proprietary linker and payload for use in an ADC directed to a NextCure novel target; Simcere Zaiming will have rights to greater China BELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025. SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration. The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC. 'We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,' said Michael Richman, NextCure's president and CEO. 'We look forward to initiating clinical development of SIM0505 in the United States.' 'We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure's recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.' Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory. About NextCure, is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere ZaimingSimcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. NextCure's Cautionary Statement Regarding Forward-Looking StatementsSome of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'continue,' 'could,' 'should,' 'due,' 'estimate,' 'expect,' 'intend,' 'hope,' 'may,' 'objective,' 'plan,' 'predict,' 'potential,' 'positioned,' 'seek,' 'target,' 'towards,' 'forward,' 'later,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and not having any products approved for commercial sale; NextCure's history of significant losses; NextCure's need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure's ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure's dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described under the heading 'Risk Factors' in NextCure's most recent Annual Report on Form 10-K and in NextCure's other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NextCure Investor InquiriesTimothy Mayer, Operating Officer(240) 762-6486IR@ Simcere Zaiming ContactsPR contacts: pr@ contacts: ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
16-06-2025
- Business
- Associated Press
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
BELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025. SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration. The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC. 'We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,' said Michael Richman, NextCure's president and CEO. 'We look forward to initiating clinical development of SIM0505 in the United States.' 'We are very pleased to collaborate with NextCure on the global development of SIM0505,' said Renhong Tang, PhD, CEO of Simcere Zaiming. 'SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure's recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.' Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, 'Simcere'). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. NextCure's Cautionary Statement Regarding Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'continue,' 'could,' 'should,' 'due,' 'estimate,' 'expect,' 'intend,' 'hope,' 'may,' 'objective,' 'plan,' 'predict,' 'potential,' 'positioned,' 'seek,' 'target,' 'towards,' 'forward,' 'later,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and not having any products approved for commercial sale; NextCure's history of significant losses; NextCure's need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure's ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure's dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described under the heading 'Risk Factors' in NextCure's most recent Annual Report on Form 10-K and in NextCure's other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NextCure Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected] Simcere Zaiming Contacts PR contacts: [email protected] IR contacts: [email protected]
Yahoo
16-06-2025
- Business
- Yahoo
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025 Initial Phase 1 clinical data is expected in the first half of 2026 NextCure also gains rights to Simcere Zaiming's proprietary linker and payload for use in an ADC directed to a NextCure novel target; Simcere Zaiming will have rights to greater China BELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025. SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration. The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC. 'We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,' said Michael Richman, NextCure's president and CEO. 'We look forward to initiating clinical development of SIM0505 in the United States.' 'We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure's recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.' Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory. About NextCure, is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere ZaimingSimcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. NextCure's Cautionary Statement Regarding Forward-Looking StatementsSome of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'continue,' 'could,' 'should,' 'due,' 'estimate,' 'expect,' 'intend,' 'hope,' 'may,' 'objective,' 'plan,' 'predict,' 'potential,' 'positioned,' 'seek,' 'target,' 'towards,' 'forward,' 'later,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and not having any products approved for commercial sale; NextCure's history of significant losses; NextCure's need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure's ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure's dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described under the heading 'Risk Factors' in NextCure's most recent Annual Report on Form 10-K and in NextCure's other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NextCure Investor InquiriesTimothy Mayer, Operating Officer(240) 762-6486IR@ Simcere Zaiming ContactsPR contacts: pr@ contacts: ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
