Latest news with #JasmineCui
Business Wire
3 days ago
- Business
- Business Wire
InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor Mesutoclax for Myelodysplastic Syndromes 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 B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndromes (MDS). Mesutoclax is an important global asset of InnoCare in the field of hematology. This approval marks the Company will initiate the clinical trial for the fourth indication of our BCL2 inhibitor. Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Myelodysplastic syndrome (MDS) is a group of heterogeneous clonal myeloid diseases characterized by the abnormal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myelodysplasia, ineffective hematopoiesis, peripheral-blood cytopenia, and a high risk of progression to acute myeloid leukemia (AML). The annual incidence of myelodysplastic syndromes is about 4 cases/100,000 people/year (reaching 40–50/100,000 in patients aged ≥ 70 years). Mesutoclax has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China. The Company is accelerating patient enrollment of a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as a clinical trial of mesutoclax for the treatment of AML. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, 'Mesutoclax is an important global asset of our company in the field of hematology. We are delighted to receive approval to initiate the clinical trial for the fourth indication of our BCL2 inhibitor. We will accelerate the clinical development of mesutoclax across multiple indications in China and globally to bring benefits to patients as early as possible.' 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
3 days ago
- Business
- Yahoo
InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor Mesutoclax for Myelodysplastic Syndromes in China
BEIJING, May 29, 2025--(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 B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndromes (MDS). Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Myelodysplastic syndrome (MDS) is a group of heterogeneous clonal myeloid diseases characterized by the abnormal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myelodysplasia, ineffective hematopoiesis, peripheral-blood cytopenia, and a high risk of progression to acute myeloid leukemia (AML). The annual incidence of myelodysplastic syndromes is about 4 cases/100,000 people/year (reaching 40–50/100,000 in patients aged ≥ 70 years). Mesutoclax has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China. The Company is accelerating patient enrollment of a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as a clinical trial of mesutoclax for the treatment of AML. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Mesutoclax is an important global asset of our company in the field of hematology. We are delighted to receive approval to initiate the clinical trial for the fourth indication of our BCL2 inhibitor. We will accelerate the clinical development of mesutoclax across multiple indications in China and globally to bring benefits to patients as early as possible." 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. View source version on Contacts Media Chunhua Investors 86-10-66609999ir@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
16-05-2025
- Health
- Yahoo
InnoCare Announces First Patient Dosed in the Phase II/IIII Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Vitiligo in China
BEIJING, May 16, 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 first patient has been dosed in the Phase II/III clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with non-segmental vitiligo in China. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including vitiligo, atopic dermatitis (AD), prurigo nodularis, etc., with broad market potential. TYK2 is a non-receptor tyrosine kinase and a member of the JAK kinase family. It plays a key role in the JAK-STAT signaling pathway and is critically involved in the pathogenesis of inflammatory diseases. Vitiligo happens when skin melanocytes are destroyed, leading to loss of pigment, and leaving white patches on the skin. Vitiligo affects approximately 0.5%–2%1 of the global population. It is a chronic condition that requires long-term treatment. The goals of therapy include disease stabilization, repigmentation, and maintenance treatment to prevent recurrence of depigmentation. Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, "Vitiligo imposes significant psychological and social burdens on patients. Many patients experience decreased self-confidence, social barriers, and other challenges. There remains a lack of effective treatments, highlighting substantial unmet medical needs. We will accelerate the clinical development of soficitinib and look forward to bringing benefits to patients with vitiligo and other autoimmune diseases as early as possible." In addition to vitiligo, the clinical development of soficitinib for other autoimmune diseases is also progressing, including the Phase III registrational trial for atopic dermatitis. 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. 1 Shanghai Municipal Health Commission View source version on Contacts MediaChunhua Investors86-10-66609999ir@
Yahoo
12-05-2025
- Business
- Yahoo
InnoCare's Mesutoclax Receives Breakthrough Therapy Designation from China's NMPA
BEIJING, May 12, 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 its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China! Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We are delighted that mesutoclax has been granted Breakthrough Therapy Designation, which will help expedite multi-center, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible." Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML. The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. 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. View source version on Contacts Media Chunhua 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
12-05-2025
- Business
- Business Wire
InnoCare's Mesutoclax Receives Breakthrough Therapy Designation from China's NMPA
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 its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China! This marks the first BCL2 inhibitor to receive BTD recognition in China! Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial for CLL/SLL and a clinical trial for AML. Share Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, 'We are delighted that mesutoclax has been granted Breakthrough Therapy Designation, which will help expedite multi-center, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible.' Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML. The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. 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.
