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.
InnoCare Pharma is deeply committed to original innovation. With sustained R&D investment, the company has progressed from rapidly catching up to running neck-and-neck and now gradually taking the lead. On one hand, it has built a differentiated product portfolio, achieved continuous scale-up of core products, and strengthened its commercialization capabilities. On the other hand, it continues to significantly invest in cutting-edge global technology platforms, having now established nearly ten advanced R&D platforms. This expands its technological footprint beyond small molecules into biologics, next-generation antibody-drug conjugates (ADCs), protein degradation, and other emerging areas, forming a systematic strategic layout.
Meanwhile, InnoCare Pharma is accelerating clinical trials both in China and globally, with multiple breakthrough-potential innovative drugs now in late-stage clinical development, poised to bring new hope to patients...
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.
InnoCare Pharma is deeply committed to original innovation. With sustained R&D investment, the company has progressed from rapidly catching up to running neck-and-neck and now gradually taking the lead. On one hand, it has built a differentiated product portfolio, achieved continuous scale-up of core products, and strengthened its commercialization capabilities. On the other hand, it continues to significantly invest in cutting-edge global technology platforms, having now established nearly ten advanced R&D platforms. This expands its technological footprint beyond small molecules into biologics, next-generation antibody-drug conjugates (ADCs), protein degradation, and other emerging areas, forming a systematic strategic layout.
Meanwhile, InnoCare Pharma is accelerating clinical trials both in China and globally, with multiple breakthrough-potential innovative drugs now in late-stage clinical development, poised to bring new hope to patients...
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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...
The Journal of Autoimmunity recently published research findings on orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of systemic lupus erythematosus (SLE). This study is the first to confirm that orelabrutinib is well tolerated and demonstrates clear efficacy in patients with active SLE, marking it as a potential candidate to become the world’s first BTK inhibitor approved for SLE treatment. Professor Li Ru and Associate Chief Physician Li Xue from the Department of Rheumatology and Immunology/Institute at Peking University People's Hospital are co-first authors of the paper, and Professor Li Zhanguo is the corresponding author.
This study conducted a multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase Ib/IIa clinical trial across 11 centers in China, in which patients were randomly assigned to receive once-daily oral doses of orelabrutinib at 50 mg, 80 mg, 100 mg, or placebo for a total of 12 weeks.
Among all evaluable patients, the SLE Responder Index-4 (SRI-4) response rates in the 50 mg, 80 mg, and 100 mg groups were 50%, 62%, and 64%, respectively—significantly higher than the 36% rate in the placebo group—demonstrating a dose-dependent trend in efficacy improvement. Notably, in patients with moderate-to-severe disease activity at screening (SLEDAI-2K > 8), the response rates in the respective dose groups reached 80%, 83%, and 100%, significantly outperforming the placebo group (0%). Additionally, the study observed...
This study conducted a multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase Ib/IIa clinical trial across 11 centers in China, in which patients were randomly assigned to receive once-daily oral doses of orelabrutinib at 50 mg, 80 mg, 100 mg, or placebo for a total of 12 weeks.
Among all evaluable patients, the SLE Responder Index-4 (SRI-4) response rates in the 50 mg, 80 mg, and 100 mg groups were 50%, 62%, and 64%, respectively—significantly higher than the 36% rate in the placebo group—demonstrating a dose-dependent trend in efficacy improvement. Notably, in patients with moderate-to-severe disease activity at screening (SLEDAI-2K > 8), the response rates in the respective dose groups reached 80%, 83%, and 100%, significantly outperforming the placebo group (0%). Additionally, the study observed...
Columns InnoCare Pharma's novel CDH17-targeting ADC, ICP-B208, has administered its first dose to a patient.
InnoCare Pharma (SSE: 688428; HKEX: 09969) announced that its independently developed novel antibody-drug conjugate (ADC), ICP-B208, which targets CDH17, has administered its first dose to a patient.
Built on InnoCare Pharma’s proprietary ADC technology platform, ICP-B208 consists of a humanized anti-CDH17 antibody linked via a protease-cleavable linker to a potent payload independently developed by the company, enabling precise targeting of tumor cells while minimizing off-target effects to the greatest extent possible.
CDH17 belongs to the cadherin family and plays a key role in tumor cell proliferation, migration, and metastasis. It is highly expressed specifically in various gastrointestinal solid tumors such as colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract cancer, making it one of the most promising emerging targets in the global ADC field. Currently, there are no CDH17-targeting ADC drugs on the market worldwide.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'Following our novel B7-H3-targeting ADC, ICP-B794, we are pleased to see our second ADC candidate advancing rapidly in clinical development. Leveraging our proprietary and differentiated ADC platform, we have developed multiple ADC candidates that demonstrate both potent anti-tumor activity and favorable safety profiles, aiming to deliver better innovative treatment options for cancer patients worldwide.'
Built on InnoCare Pharma’s proprietary ADC technology platform, ICP-B208 consists of a humanized anti-CDH17 antibody linked via a protease-cleavable linker to a potent payload independently developed by the company, enabling precise targeting of tumor cells while minimizing off-target effects to the greatest extent possible.
CDH17 belongs to the cadherin family and plays a key role in tumor cell proliferation, migration, and metastasis. It is highly expressed specifically in various gastrointestinal solid tumors such as colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract cancer, making it one of the most promising emerging targets in the global ADC field. Currently, there are no CDH17-targeting ADC drugs on the market worldwide.
Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'Following our novel B7-H3-targeting ADC, ICP-B794, we are pleased to see our second ADC candidate advancing rapidly in clinical development. Leveraging our proprietary and differentiated ADC platform, we have developed multiple ADC candidates that demonstrate both potent anti-tumor activity and favorable safety profiles, aiming to deliver better innovative treatment options for cancer patients worldwide.'
InnoCare Pharma Limited (HKEX: 09969; SSE: 688428) today announced that results from the global Phase III frontMIND study of tafasitamab combination therapy were presented as a late-breaking oral presentation at the Plenary Session of the 2026 European Hematology Association (EHA) Annual Meeting. The results demonstrated that, compared with the current first-line standard regimen R-CHOP, the tafasitamab plus lenalidomide and R-CHOP regimen (Tafa-Len-R-CHOP) significantly improved progression-free survival (PFS) with strong statistical significance and clinical relevance, offering a potential new first-line standard of care for patients with high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
Plenary Session Oral Presentation
Phase III frontMIND Study Results of Tafasitamab Plus Lenalidomide and R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (Abstract #: S101)
This 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.
Regarding efficacy, after a median follow-up of 35.2 months, Tafa-Len-R-CHOP reduced the risk of disease progression or death...
Plenary Session Oral Presentation
Phase III frontMIND Study Results of Tafasitamab Plus Lenalidomide and R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (Abstract #: S101)
This 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.
Regarding efficacy, after a median follow-up of 35.2 months, Tafa-Len-R-CHOP reduced the risk of disease progression or death...
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