InnoCare (SSE: 688428; HKEX: 09969) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the initiation of a registrational Phase III clinical trial for its self-developed novel BCL2 inhibitor, mesutoclax (ICP-248), in combination with azacitidine. The trial will conduct a head-to-head comparison against venetoclax combined with azacitidine for the treatment of elderly or unfit patients with newly diagnosed acute myeloid leukemia (AML).
This is a randomized, open-label, multicenter, registrational Phase III clinical trial for elderly or unfit patients with newly diagnosed AML, with overall survival (OS) as the primary endpoint.
Mesutoclax is a novel oral highly selective BCL2 inhibitor. BCL2 is a key regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various malignant hematologic tumors. Mesutoclax exerts anti-tumor efficacy by selectively inhibiting BCL2, thereby restoring the programmed cell death mechanism in tumor cells. Mesutoclax has received two Breakthrough Therapy Designations (BTD) from the CDE in China.
Data released by the American Society of Clinical Oncology (ASCO) this May showed that mesutoclax combined with azacitidine demonstrated favorable efficacy and safety in treating AML patients. As of April 13, 2026, among evaluable...
This is a randomized, open-label, multicenter, registrational Phase III clinical trial for elderly or unfit patients with newly diagnosed AML, with overall survival (OS) as the primary endpoint.
Mesutoclax is a novel oral highly selective BCL2 inhibitor. BCL2 is a key regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various malignant hematologic tumors. Mesutoclax exerts anti-tumor efficacy by selectively inhibiting BCL2, thereby restoring the programmed cell death mechanism in tumor cells. Mesutoclax has received two Breakthrough Therapy Designations (BTD) from the CDE in China.
Data released by the American Society of Clinical Oncology (ASCO) this May showed that mesutoclax combined with azacitidine demonstrated favorable efficacy and safety in treating AML patients. As of April 13, 2026, among evaluable...
Recently, Global Times published an op-ed by Cui Jisong, detailing how innovative pharmaceutical companies can seize the industry’s value realization window.
Currently, the global pharmaceutical landscape is undergoing restructuring, and Chinese innovative drugs are entering a phase of rapid overseas expansion. Starting in 2023, the global supply-demand dynamics for innovative drugs have clearly shifted, with these changes becoming especially pronounced in 2025—marking a concentrated period of value realization for industry innovation.
In recent years, multinational pharmaceutical companies have faced a wave of patent expirations and insufficient internal pipelines of new drugs, creating urgent demand for differentiated innovative assets to fill their R&D gaps. China’s innovative drug sector, rooted in the 2015 reform of drug evaluation and approval systems and bolstered by continuously optimized industrial support policies, a comprehensive full-chain industrial ecosystem, abundant specialized talent, and steadily increasing R&D investment, has persistently advanced in original innovation and progressively built global competitiveness. A cohort of domestically developed, globally novel drug candidates with independent intellectual property rights continues to enter international markets, driving cross-border licensing collaborations between Chinese and foreign pharmaceutical firms into a new phase characterized by larger transaction scales and deeper cooperation dimensions.
Amid the wave of Chinese innovative drug globalization, InnoCare Pharma has consistently remained at the forefront. In 2025, InnoCare entered into a global collaboration exceeding USD 2 billion with Zenas BioPharma on its autoimmune disease pipeline. Its independently developed orelabrutinib was previously designated under China’s National Science and Technology Major Project for 'Major New Drug Creation' and remains the only BTK inhibitor globally to have demonstrated efficacy in Phase II trials for systemic lupus erythematosus.
Innovative drugs’ inclusion among the 'new trio of high-quality exports' and their successful high-end globalization reflect robust innovation capabilities and...
Currently, the global pharmaceutical landscape is undergoing restructuring, and Chinese innovative drugs are entering a phase of rapid overseas expansion. Starting in 2023, the global supply-demand dynamics for innovative drugs have clearly shifted, with these changes becoming especially pronounced in 2025—marking a concentrated period of value realization for industry innovation.
In recent years, multinational pharmaceutical companies have faced a wave of patent expirations and insufficient internal pipelines of new drugs, creating urgent demand for differentiated innovative assets to fill their R&D gaps. China’s innovative drug sector, rooted in the 2015 reform of drug evaluation and approval systems and bolstered by continuously optimized industrial support policies, a comprehensive full-chain industrial ecosystem, abundant specialized talent, and steadily increasing R&D investment, has persistently advanced in original innovation and progressively built global competitiveness. A cohort of domestically developed, globally novel drug candidates with independent intellectual property rights continues to enter international markets, driving cross-border licensing collaborations between Chinese and foreign pharmaceutical firms into a new phase characterized by larger transaction scales and deeper cooperation dimensions.
Amid the wave of Chinese innovative drug globalization, InnoCare Pharma has consistently remained at the forefront. In 2025, InnoCare entered into a global collaboration exceeding USD 2 billion with Zenas BioPharma on its autoimmune disease pipeline. Its independently developed orelabrutinib was previously designated under China’s National Science and Technology Major Project for 'Major New Drug Creation' and remains the only BTK inhibitor globally to have demonstrated efficacy in Phase II trials for systemic lupus erythematosus.
Innovative drugs’ inclusion among the 'new trio of high-quality exports' and their successful high-end globalization reflect robust innovation capabilities and...
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Recently, CCTV's 'Xinwen Lianbo' aired a major news segment titled 'China's Pharmaceutical Industry Achieves Accelerated Innovation Breakthroughs in the First Half of the Year,' citing InnoCare Pharma. The report stated that in the first half of this year, China's pharmaceutical industry has seen accelerated innovation breakthroughs, with enterprises continuously enhancing their independent R&D capabilities and strengthening the momentum for pharmaceutical development. This year, China's first broad-spectrum targeted anticancer drug (zolbetuximab) began clinical use in major hospitals nationwide, having received approval just eight months after its marketing application was submitted.
The 'Xinwen Lianbo' cameras focused on the production lines and clinical application scenarios of InnoCare Pharma’s independently developed orelabrutinib (Yinuokai) and zolbetuximab (Yinuoxin).
Innovation Driven by Original Research Powers Development
InnoCare Pharma is deeply committed to original innovation, continuously enhancing its independent R&D capabilities and accelerating breakthroughs in innovation outcomes.
Novel BTK inhibitor orelabrutinib (Yinuokai)
China's first and only approved BTK inhibitor for the treatment of marginal zone lymphoma
The world's only BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for systemic lupus erythematosus
Novel TRK inhibitor zorelotinib (Yinuoxin)
China's first domestically developed TRK inhibitor approved for marketing
Novel CD19 monoclonal antibody tafasitamab (Minnuokai)
China's first approved CD19 monoclonal antibody for the treatment of relapsed/refractory diffuse large B-cell lymphoma
Novel TYK2 inhibitor sofitinib (ICP-332)
· The world's first Phase III registrational clinical trial for atopic dermatitis has succeeded...
The 'Xinwen Lianbo' cameras focused on the production lines and clinical application scenarios of InnoCare Pharma’s independently developed orelabrutinib (Yinuokai) and zolbetuximab (Yinuoxin).
Innovation Driven by Original Research Powers Development
InnoCare Pharma is deeply committed to original innovation, continuously enhancing its independent R&D capabilities and accelerating breakthroughs in innovation outcomes.
Novel BTK inhibitor orelabrutinib (Yinuokai)
China's first and only approved BTK inhibitor for the treatment of marginal zone lymphoma
The world's only BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for systemic lupus erythematosus
Novel TRK inhibitor zorelotinib (Yinuoxin)
China's first domestically developed TRK inhibitor approved for marketing
Novel CD19 monoclonal antibody tafasitamab (Minnuokai)
China's first approved CD19 monoclonal antibody for the treatment of relapsed/refractory diffuse large B-cell lymphoma
Novel TYK2 inhibitor sofitinib (ICP-332)
· The world's first Phase III registrational clinical trial for atopic dermatitis has succeeded...
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InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that the combination regimen of orelabrutinib and mesutoclax (ICP-248) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy.
Orelabrutinib is a novel, highly selective BTK inhibitor independently developed by InnoCare Pharma, which effectively avoids off-target effects and their associated adverse reactions, significantly enhancing both efficacy and safety. Mesutoclax is a novel, orally administered, highly selective BCL2 inhibitor independently developed by the company. By selectively inhibiting the BCL2 protein, it restores tumor cell apoptosis, thereby suppressing tumor growth and spread.
Mesutoclax is the first BCL2 inhibitor in China to receive BTD for the treatment of BTK inhibitor-pretreated mantle cell lymphoma, marking the second BTD granted to this novel BCL2 inhibitor.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'We are delighted that the oral combination regimen of orelabrutinib and mesutoclax has received Breakthrough Therapy Designation. We will accelerate clinical development to provide better treatment options to more patients as soon as possible.'
In May this year, the U.S. ...
Orelabrutinib is a novel, highly selective BTK inhibitor independently developed by InnoCare Pharma, which effectively avoids off-target effects and their associated adverse reactions, significantly enhancing both efficacy and safety. Mesutoclax is a novel, orally administered, highly selective BCL2 inhibitor independently developed by the company. By selectively inhibiting the BCL2 protein, it restores tumor cell apoptosis, thereby suppressing tumor growth and spread.
Mesutoclax is the first BCL2 inhibitor in China to receive BTD for the treatment of BTK inhibitor-pretreated mantle cell lymphoma, marking the second BTD granted to this novel BCL2 inhibitor.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'We are delighted that the oral combination regimen of orelabrutinib and mesutoclax has received Breakthrough Therapy Designation. We will accelerate clinical development to provide better treatment options to more patients as soon as possible.'
In May this year, the U.S. ...
InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that its independently developed novel TYK2 inhibitor, fadeucravacitinib (ICP-488), has met the primary endpoint in a Phase III registrational clinical trial for moderate-to-severe plaque psoriasis.
This Phase III registrational clinical study is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, and tolerability of fadeucravacitinib in patients with moderate-to-severe plaque psoriasis.
The results showed that fadeucravacitinib met the primary endpoint of the Phase III registrational clinical study, demonstrating highly statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, consistently showing significant therapeutic effects across all efficacy assessment measures.
Regarding safety, the safety profile of fadeucravacitinib was consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Fadeucravacitinib is an orally administered, highly selective TYK2 allosteric inhibitor that blocks IL-23, IL-12, and...
This Phase III registrational clinical study is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, and tolerability of fadeucravacitinib in patients with moderate-to-severe plaque psoriasis.
The results showed that fadeucravacitinib met the primary endpoint of the Phase III registrational clinical study, demonstrating highly statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, consistently showing significant therapeutic effects across all efficacy assessment measures.
Regarding safety, the safety profile of fadeucravacitinib was consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Fadeucravacitinib is an orally administered, highly selective TYK2 allosteric inhibitor that blocks IL-23, IL-12, and...
The international top-tier medical journal The Lancet recently published results from the global Phase III frontMIND study evaluating tafasitamab combination therapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The results showed that, compared with the standard R-CHOP regimen, the tafasitamab plus lenalidomide and R-CHOP regimen (tafa-Len-R-CHOP) reduced the risk of disease progression or death by 25% and significantly improved progression-free survival. Post-hoc analysis in patients confirmed as having DLBCL following central pathology review demonstrated even more pronounced clinical benefit.
The frontMIND study is a randomized, double-blind, placebo-controlled international multicenter trial designed to identify a first-line treatment regimen with superior efficacy and safety compared to R-CHOP.
After a median follow-up of 35.2 months, the tafa-len-R-CHOP regimen reduced the risk of disease progression or death by 25% compared to R-CHOP (hazard ratio HR=0.75, P=0.0194), increasing the 2-year progression-free survival (PFS) rate by 8.2% and the 3-year PFS rate by 6.6%.
Across all pre-specified subgroups, the tafa-Len-R-CHOP regimen consistently demonstrated a trend toward improved progression-free survival, including across lymphoma subtypes confirmed by central laboratory testing and molecular subtypes based on cell-of-origin (COO)—namely activated B-cell-like (ABC) and germinal...
The frontMIND study is a randomized, double-blind, placebo-controlled international multicenter trial designed to identify a first-line treatment regimen with superior efficacy and safety compared to R-CHOP.
After a median follow-up of 35.2 months, the tafa-len-R-CHOP regimen reduced the risk of disease progression or death by 25% compared to R-CHOP (hazard ratio HR=0.75, P=0.0194), increasing the 2-year progression-free survival (PFS) rate by 8.2% and the 3-year PFS rate by 6.6%.
Across all pre-specified subgroups, the tafa-Len-R-CHOP regimen consistently demonstrated a trend toward improved progression-free survival, including across lymphoma subtypes confirmed by central laboratory testing and molecular subtypes based on cell-of-origin (COO)—namely activated B-cell-like (ABC) and germinal...
InnoCare Pharma (SSE: 688428; HKEX: 09969) announced that the Phase II portion of its Phase II/III study evaluating soficitinib (ICP-332), a next-generation oral TYK2 inhibitor independently developed by the company, in adults with non-segmental vitiligo has met its primary endpoint.
This is a Phase II/III, randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical trial designed to evaluate the efficacy and safety of soficitinib in patients with non-segmental vitiligo. The study consists of two stages: an initial Phase II followed by a Phase III.
Phase II results showed that at week 24, the Facial Vitiligo Area Scoring Index (F-VASI) demonstrated significant improvement from baseline: the once-daily 80 mg soficitinib group showed a 38.8% reduction from baseline, the 120 mg once-daily group showed a 41.2% reduction, compared to only a 2.2% reduction in the placebo group. The differences between both soficitinib dose groups and the placebo group were statistically significant (P<0.0001).
Soficitinib demonstrated a favorable safety profile consistent with previous clinical studies, was generally well tolerated, and no new safety signals were observed. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Soficitini...
This is a Phase II/III, randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical trial designed to evaluate the efficacy and safety of soficitinib in patients with non-segmental vitiligo. The study consists of two stages: an initial Phase II followed by a Phase III.
Phase II results showed that at week 24, the Facial Vitiligo Area Scoring Index (F-VASI) demonstrated significant improvement from baseline: the once-daily 80 mg soficitinib group showed a 38.8% reduction from baseline, the 120 mg once-daily group showed a 41.2% reduction, compared to only a 2.2% reduction in the placebo group. The differences between both soficitinib dose groups and the placebo group were statistically significant (P<0.0001).
Soficitinib demonstrated a favorable safety profile consistent with previous clinical studies, was generally well tolerated, and no new safety signals were observed. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Soficitini...
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InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that its independently developed novel tyrosine kinase 2 (TYK2) inhibitor, soficitinib (ICP-332), has met the primary endpoint in a Phase III clinical trial for the treatment of moderate-to-severe atopic dermatitis (AD).
The Phase III clinical trial of soficitinib is a randomized, double-blind, placebo-controlled, multicenter pivotal study designed to evaluate the efficacy, safety, and tolerability of the drug in patients with moderate-to-severe atopic dermatitis.
Soficitinib met the primary endpoint in the pivotal Phase III clinical trial, demonstrating statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, showing consistently significant therapeutic effects across all efficacy measures.
Soficitinib demonstrated a favorable safety profile consistent with prior clinical studies, with no new safety signals identified. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Soficitinib is InnoCare Pharma's independently developed, highly potent and selective oral TYK2 inhibitor, being developed for the treatment of multiple T-cell-mediated autoimmune diseases. Its current indications are strategically focused on the broad dermatology market...
The Phase III clinical trial of soficitinib is a randomized, double-blind, placebo-controlled, multicenter pivotal study designed to evaluate the efficacy, safety, and tolerability of the drug in patients with moderate-to-severe atopic dermatitis.
Soficitinib met the primary endpoint in the pivotal Phase III clinical trial, demonstrating statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, showing consistently significant therapeutic effects across all efficacy measures.
Soficitinib demonstrated a favorable safety profile consistent with prior clinical studies, with no new safety signals identified. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.
Soficitinib is InnoCare Pharma's independently developed, highly potent and selective oral TYK2 inhibitor, being developed for the treatment of multiple T-cell-mediated autoimmune diseases. Its current indications are strategically focused on the broad dermatology market...
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Signal Transduction and Targeted Therapy (STTT), an international academic journal under Nature, recently published a paper titled 'Orelabrutinib versus Chemoimmunotherapy as First-Line Treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Randomized Phase III Trial.' The paper states that orelabrutinib significantly prolongs progression-free survival (PFS), reducing the risk of disease progression or death by 68%, achieving deeper and more durable responses, demonstrating a higher overall response rate (ORR), and exhibiting an excellent safety profile, making it an effective first-line treatment option for CLL/SLL.
The paper’s co-corresponding authors are Professor Li Jianyong from Jiangsu Province Hospital and Professor Qiu Lugui from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. The co-first authors are Professor Li Fei from the First Affiliated Hospital of Nanchang University, Professor Zhou Keshu from Henan Cancer Hospital, and Professor Xu Wei from Jiangsu Province Hospital.
The primary endpoint of this Phase III trial was progression-free survival (PFS) assessed by an Independent Review Committee (IRC). Secondary endpoints included overall response rate (ORR), duration of response (DoR), and safety, as evaluated by both the IRC and investigators.
Results assessed by the Independent Review Committee (IRC) showed that orelabrutinib significantly prolonged progression-free survival, with a hazard ratio (HR) of 0...
The paper’s co-corresponding authors are Professor Li Jianyong from Jiangsu Province Hospital and Professor Qiu Lugui from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. The co-first authors are Professor Li Fei from the First Affiliated Hospital of Nanchang University, Professor Zhou Keshu from Henan Cancer Hospital, and Professor Xu Wei from Jiangsu Province Hospital.
The primary endpoint of this Phase III trial was progression-free survival (PFS) assessed by an Independent Review Committee (IRC). Secondary endpoints included overall response rate (ORR), duration of response (DoR), and safety, as evaluated by both the IRC and investigators.
Results assessed by the Independent Review Committee (IRC) showed that orelabrutinib significantly prolonged progression-free survival, with a hazard ratio (HR) of 0...
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