Latest news with #InnoCarePharma
Yahoo
04-07-2025
- Business
- Yahoo
China's NMPA approves initiation of InnoCare's trial of B7-H3 targeted ADC
The China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) has granted approval to the investigational new drug (IND) application of InnoCare Pharma to initiate a trial of ICP-B794, a B7-H3 targeted antibody-drug conjugate (ADC). This marks a step forward in the development of targeted therapies for solid tumours, including oesophageal, nasopharyngeal, lung, and prostate cancers, as well as head and neck squamous cell carcinomas, among others. The ADC is designed to deliver a potent payload through a protease-cleavable linker. This targeting mechanism is expected to decrease off-target effects and improve treatment outcomes for patients with solid tumours. According to InnoCare Pharma, there are currently no B7-H3-targeted therapies that have received marketing approval. This type I transmembrane protein is expressed highly in various solid tumours and is observed as a potential anti-tumour target. InnoCare Pharma CEO, chairwoman and co-founder Dr Jasmine Cui said: "ICP-B794 is developed from the company's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumour-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. 'As the platform continues to evolve, the company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology." InnoCare is focused on developing a drug portfolio targeting a wide range of solid tumour indications. The company's research and development (R&D) team discovers and develops platforms to address solid tumours. Their approach includes leveraging technologies to detect and progress potential drug candidates that could provide clinical advantages. Its ADC technology platform is complemented by precision medicine candidates like the tropomyosin receptor kinase (TRK) inhibitor zurletrectinib (ICP-723). In February 2025, the NMPA approved a Phase III trial of InnoCare Pharma's ICP-248 (Mesutoclax) with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). "China's NMPA approves initiation of InnoCare's trial of B7-H3 targeted ADC" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
04-07-2025
- Business
- Yahoo
China's NMPA approves initiation of InnoCare's trial of B7-H3 targeted ADC
The China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) has granted approval to the investigational new drug (IND) application of InnoCare Pharma to initiate trial of ICP-B794, a B7-H3 targeted antibody-drug conjugate (ADC). This marks a step forward in the development of targeted therapies for solid tumours, including oesophageal, nasopharyngeal, lung, prostate cancers, and head and neck squamous cell carcinomas, among others. The ADC is designed to deliver a potent payload through a protease-cleavable linker. This targeting mechanism is expected to decrease off-target effects and improve treatment outcomes for patients with solid tumours. According to the company, there are currently no B7-H3-targeted therapies that have received marketing approval. This type I transmembrane protein is expressed highly in various solid tumours and is observed as a potential anti-tumour target. InnoCare Pharma chairwoman, CEO and co-founder Dr Jasmine Cui said: "ICP-B794 is developed from the company's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumour-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. 'As the platform continues to evolve, the company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology." InnoCare is focused on developing a drug portfolio targeting a wide range of solid tumour indications. The company's research and development (R&D) team discovers and develops platforms to address solid tumours. Their approach includes leveraging technologies to detect and progress potential drug candidates that could provide clinical advantages. Its ADC technology platform is complemented by precision medicine candidates like the tropomyosin receptor kinase (TRK) inhibitor zurletrectinib (ICP-723). In February 2025, the NMPA approved a Phase III trial of InnoCare Pharma's ICP-248 (Mesutoclax) with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). "China's NMPA approves initiation of InnoCare's trial of B7-H3 targeted ADC" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
04-07-2025
- Business
- Business Wire
InnoCare Announces Approval of Clinical Trial of a Novel ADC ICP-B794 in China
BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of a novel B7-H3 targeted ADC ICP-B794. ICP-B794 is developed from InnoCare's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients. Share ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "ICP-B794 is developed from the Company's proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology." With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare's proprietary ADC technology platform, alongside promising precision medicine candidates like TRK inhibitor zurletrectinib (ICP-723), positions the Company to establish a strong presence in the field of solid tumor treatment. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
Yahoo
21-05-2025
- Business
- Yahoo
InnoCare Announces the Approval of Minjuvi® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China
BEIJING, May 21, 2025--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. "The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR)," said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. "The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients." "The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL," said Professor Weili Zhao from Shanghai Ruijin Hospital. "We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo'ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy." Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "Today's approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China." Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo'ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases1. About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. In the United States, Monjuvi® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Hematology Branch of Chinese Medical Association View source version on Contacts Media Chunhua Lu86+ Investors 86+10-66609999ir@ Error 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
Business Wire
21-05-2025
- Health
- Business Wire
InnoCare Announces the Approval of Minjuvi ® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China
BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi ® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. Minjuvi® (tafasitamab) is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. 'The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR),' said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. 'The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.' 'The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL,' said Professor Weili Zhao from Shanghai Ruijin Hospital. 'We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo'ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.' Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, 'Today's approval marks another important milestone for InnoCare as we will celebrate our 10 th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China.' Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo'ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases 1. About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are registered trademarks of Incyte. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Hematology Branch of Chinese Medical Association
