– The phase 1 trial aims to evaluate the safety, tolerability, and pharmacokinetic properties of ICP-054 (ZB021) in healthy participants
– Data from the single ascending dose and multiple ascending dose portions of the phase 1 trial are expected to be released by the end of 2026
Beijing, China, May 13, 2026 - InnoCare Pharma (SSE code: 688428; HKEX code: 09969), a high-tech biopharmaceutical company, today announced that the first participant has been enrolled in the phase 1 clinical trial of ICP-054 (ZB021), a new oral, potentially Best-in-class IL-17AA/AF inhibitor。
Preclinical data for ICP-054 have demonstrated favorable pharmacological and safety profiles, which strongly support the initiation of the phase 1 clinical trial. In preclinical animal models, ICP-054 effectively inhibited the IL-17AA/AF signaling pathway and exhibited anti-inflammatory activity. Moreover, in various preclinical animal models (including non-human primates), ICP-054 showed excellent oral bioavailability. All these data suggest that ICP-054 could provide a novel therapeutic option for autoimmune and inflammatory diseases associated with abnormal activation of the IL-17 signaling pathway
InnoCare Pharma and Zenas are collaborating on the single ascending dose (SAD) study and multiple ascending dose escalation in the phase 1 clinical trial...
– Data from the single ascending dose and multiple ascending dose portions of the phase 1 trial are expected to be released by the end of 2026
Beijing, China, May 13, 2026 - InnoCare Pharma (SSE code: 688428; HKEX code: 09969), a high-tech biopharmaceutical company, today announced that the first participant has been enrolled in the phase 1 clinical trial of ICP-054 (ZB021), a new oral, potentially Best-in-class IL-17AA/AF inhibitor。
Preclinical data for ICP-054 have demonstrated favorable pharmacological and safety profiles, which strongly support the initiation of the phase 1 clinical trial. In preclinical animal models, ICP-054 effectively inhibited the IL-17AA/AF signaling pathway and exhibited anti-inflammatory activity. Moreover, in various preclinical animal models (including non-human primates), ICP-054 showed excellent oral bioavailability. All these data suggest that ICP-054 could provide a novel therapeutic option for autoimmune and inflammatory diseases associated with abnormal activation of the IL-17 signaling pathway
InnoCare Pharma and Zenas are collaborating on the single ascending dose (SAD) study and multiple ascending dose escalation in the phase 1 clinical trial...
The Chinese Society of Clinical Oncology (CSCO) recently released its 2026 series of cancer diagnosis and treatment guidelines. With strong clinical evidence and excellent efficacy and safety, Nuocan Health Innovation’s (SSE code: 688428; HKEX code: 09969) core pipeline drugs, Orelabrutinib (Innocare), Tafasitamab (Minocare), and Zolbetuximab (Innochek), secured multiple important recommendations in the 'CSCO Lymphoma Diagnosis and Treatment Guidelines 2026 Edition,' 'CSCO Malignant Hematological Disease Diagnosis and Treatment Guidelines 2026 Edition,' and 'CSCO Head and Neck Cancer Diagnosis and Treatment Guidelines 2026 Edition.'
In the 'CSCO Lymphoma Diagnosis and Treatment Guidelines 2026 Edition,' both Orelabrutinib and Tafasitamab achieved upgraded and new recommendations across several lymphoma subtypes, further solidifying Nuocan Health Innovation's leading position in the field of hematological tumor treatment:
· Orelabrutinib has been elevated toa Level I recommendation for first-line treatment across all populations with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)；
· Orelabrutinib continues to maintaina Level I recommendation for second-line treatment of Marginal Zone Lymphoma (MZL), while the combination regimen of Orelabrutinib with Rituximabhas newly been included as a Level II recommendation for first-line treatment of MZL, making orelabrutinib thefirst and only BTK inhibitor included in the CSCO guidelines for first-line treatment recommendations for MZL；
Orelabrutinib, as a BTK inhibitor, continues to maintain its Level II recommendation for initial treatment of mantle cell lymphoma (MCL), as well as for relapsed/refractory MCL treatment...
In the 'CSCO Lymphoma Diagnosis and Treatment Guidelines 2026 Edition,' both Orelabrutinib and Tafasitamab achieved upgraded and new recommendations across several lymphoma subtypes, further solidifying Nuocan Health Innovation's leading position in the field of hematological tumor treatment:
· Orelabrutinib has been elevated toa Level I recommendation for first-line treatment across all populations with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)；
· Orelabrutinib continues to maintaina Level I recommendation for second-line treatment of Marginal Zone Lymphoma (MZL), while the combination regimen of Orelabrutinib with Rituximabhas newly been included as a Level II recommendation for first-line treatment of MZL, making orelabrutinib thefirst and only BTK inhibitor included in the CSCO guidelines for first-line treatment recommendations for MZL；
Orelabrutinib, as a BTK inhibitor, continues to maintain its Level II recommendation for initial treatment of mantle cell lymphoma (MCL), as well as for relapsed/refractory MCL treatment...
ExpandInnoCare Pharma (SSE code: 688428; HKEX code: 09969) today announced that the company’s self-developed novel TYK2 inhibitor (ICP-488) for the treatment of Sjögren's syndrome has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) to proceed with Phase II clinical trials.
ICP-488 is an orally administered, highly selective TYK2 allosteric inhibitor. By specifically binding to the TYK2 JH2 domain, it blocks abnormal signal transduction of inflammatory cytokines such as IL-23, IL-12, and type I interferon, thereby suppressing pathological processes in autoimmune and inflammatory diseases. Sjögren's syndrome is associated with abnormal activation of the TYK2-mediated signaling pathway, and ICP-488 is expected to provide a new therapeutic option for patients.
Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte proliferation and progressive exocrine gland damage. The main clinical manifestations include impaired function of salivary and lacrimal glands, along with involvement of multiple systems and organs, significantly reducing patients' quality of life. Currently, the prevalence rate of Sjögren's syndrome in China is between 0.33% and 0.77%[1], with an estimated patient population of approximately five million. Globally, there are no approved targeted therapies for Sjögren's syndrome, representing a significant unmet clinical need.
Dr. Jisong Cui, Co-founder, Chairman, and CEO of InnoCare Pharma, stated: 'ICP-488 shows broad potential across various autoimmune diseases...
ICP-488 is an orally administered, highly selective TYK2 allosteric inhibitor. By specifically binding to the TYK2 JH2 domain, it blocks abnormal signal transduction of inflammatory cytokines such as IL-23, IL-12, and type I interferon, thereby suppressing pathological processes in autoimmune and inflammatory diseases. Sjögren's syndrome is associated with abnormal activation of the TYK2-mediated signaling pathway, and ICP-488 is expected to provide a new therapeutic option for patients.
Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte proliferation and progressive exocrine gland damage. The main clinical manifestations include impaired function of salivary and lacrimal glands, along with involvement of multiple systems and organs, significantly reducing patients' quality of life. Currently, the prevalence rate of Sjögren's syndrome in China is between 0.33% and 0.77%[1], with an estimated patient population of approximately five million. Globally, there are no approved targeted therapies for Sjögren's syndrome, representing a significant unmet clinical need.
Dr. Jisong Cui, Co-founder, Chairman, and CEO of InnoCare Pharma, stated: 'ICP-488 shows broad potential across various autoimmune diseases...
InnoCare Pharma (SSE code: 688428; HKEX code: 09969) announced that its self-developed novel ADC drug ICP-B208 targeting CDH17 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct clinical research.
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.
ICP-B208 was developed based on InnoCare Pharma’s self-developed ADC technology platform, utilizing a unique hydrophilic linker paired with a highly active payload, conjugated with a humanized anti-CDH17 antibody. Preclinical studies have shown that ICP-B208 exhibits potent anti-tumor activity even in tumors with low CDH17 expression.
Leveraging the differentiated technological advantages of its platform, InnoCare Pharma is simultaneously advancing multiple ADC innovative drugs that combine potent tumor-killing activity with safety. The novel ADC drug targeting B7-H3, ICP-B794, has already entered clinical trials, while ICP-B208 is the second self-developed ADC innovative drug from InnoCare Pharma to be approved for clinical trials.
Co-founder, Chairman, and CEO of Noah Holdings...
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.
ICP-B208 was developed based on InnoCare Pharma’s self-developed ADC technology platform, utilizing a unique hydrophilic linker paired with a highly active payload, conjugated with a humanized anti-CDH17 antibody. Preclinical studies have shown that ICP-B208 exhibits potent anti-tumor activity even in tumors with low CDH17 expression.
Leveraging the differentiated technological advantages of its platform, InnoCare Pharma is simultaneously advancing multiple ADC innovative drugs that combine potent tumor-killing activity with safety. The novel ADC drug targeting B7-H3, ICP-B794, has already entered clinical trials, while ICP-B208 is the second self-developed ADC innovative drug from InnoCare Pharma to be approved for clinical trials.
Co-founder, Chairman, and CEO of Noah Holdings...
InnoCare Pharma (SSE code: 688428; HKEX code: 09969) today announced that the company’s self-developed novel BTK inhibitor orelabrutinib has completed the enrollment of the first patient in the registrational Phase III clinical study for the treatment of systemic lupus erythematosus (SLE).
This is a randomized, double-blind, placebo-controlled, multicenter Phase III study assessing the efficacy and safety of orelabrutinib in SLE patients, with the primary endpoint being the SLE Responder Index-4 (SRI-4) response rate at Week 52 of treatment.
The Phase IIb study of orelabrutinib for SLE met its primary endpoint, becoming the world's first BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for the treatment of SLE. Under stringent corticosteroid tapering requirements, at Week 48, the once-daily (QD) 75 mg orelabrutinib dose group showed a significantly higher SLE Responder Index-4 (SRI-4) response rate compared to the placebo group (57.1% vs. 34.4%), with highly statistically significant results (p<0.05), achieving the primary endpoint. In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg QD orelabrutinib dose group was 68%, representing a substantial increase of 43% over the placebo group. More critically, the Phase IIb clinical trial strictly followed international standards in designing the corticosteroid tapering regimen, with...
This is a randomized, double-blind, placebo-controlled, multicenter Phase III study assessing the efficacy and safety of orelabrutinib in SLE patients, with the primary endpoint being the SLE Responder Index-4 (SRI-4) response rate at Week 52 of treatment.
The Phase IIb study of orelabrutinib for SLE met its primary endpoint, becoming the world's first BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for the treatment of SLE. Under stringent corticosteroid tapering requirements, at Week 48, the once-daily (QD) 75 mg orelabrutinib dose group showed a significantly higher SLE Responder Index-4 (SRI-4) response rate compared to the placebo group (57.1% vs. 34.4%), with highly statistically significant results (p<0.05), achieving the primary endpoint. In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg QD orelabrutinib dose group was 68%, representing a substantial increase of 43% over the placebo group. More critically, the Phase IIb clinical trial strictly followed international standards in designing the corticosteroid tapering regimen, with...
1
InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced that multiple research achievements of its self-developed novel BCL2 inhibitor Mesutoclax (ICP-248) and novel BTK inhibitor orelabrutinib have been selected for the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Among them,The study of Mesutoclax for the treatment of myeloid malignancies has been selected for oral presentation, while the study of Mesutoclax for the treatment of B-cell malignancies has been selected for poster presentation.
Oral presentation
Title: Safety, tolerability, and efficacy of Mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies
Title: Safety, Tolerability, and Efficacy of Mesutoclax (ICP-248) in Combination with Azacitidine in Patients with Myeloid Malignancies
Abstract Number: 6506
Session: Oral Abstract - Hematological Malignancies - Leukemia, Myelodysplastic Syndromes, and Allogeneic Transplantation
Oral Abstract Session - Hematolog...
Oral presentation
Title: Safety, tolerability, and efficacy of Mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies
Title: Safety, Tolerability, and Efficacy of Mesutoclax (ICP-248) in Combination with Azacitidine in Patients with Myeloid Malignancies
Abstract Number: 6506
Session: Oral Abstract - Hematological Malignancies - Leukemia, Myelodysplastic Syndromes, and Allogeneic Transplantation
Oral Abstract Session - Hematolog...
InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced its Q1 2026 earnings report and recent company developments as of March 31, 2026.
Over the past decade, InnoCare Pharma has achieved remarkable results. 2026 marks the beginning of the company’s next golden decade of growth, driven by an outstanding performance in 2025. In Q1 2026, the company continued to accelerate, ramping up innovation, commercialization, and globalization efforts to achieve its 2.0 strategic goals.
Commercialization and business development help the company maintain profitability
InnoCare Pharma's pharmaceutical revenue for Q1 2026 grew by 44.5% year-on-year, reaching 450 million yuan, with total revenue increasing by 38.7% year-on-year to 530 million yuan. This was primarily due to a continuous rise in drug sales and income from global business development (BD). The inclusion of orelabrutinib (brand name: InnoCare®) as a first-line treatment for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) in national insurance led to rapid scaling, while maintaining exclusive indication advantages in marginal zone lymphoma. Additionally, the commercialization of tafasitamab (brand name: Minocure®) and zolbetuximab (brand name: InnoCarexin®) brought new growth increments.
The company achieved its first annual profit in 2025, and continued to post profits in Q1 2026, with net profit soaring by 607.7% year-on-year to reach 100 million yuan...
Over the past decade, InnoCare Pharma has achieved remarkable results. 2026 marks the beginning of the company’s next golden decade of growth, driven by an outstanding performance in 2025. In Q1 2026, the company continued to accelerate, ramping up innovation, commercialization, and globalization efforts to achieve its 2.0 strategic goals.
Commercialization and business development help the company maintain profitability
InnoCare Pharma's pharmaceutical revenue for Q1 2026 grew by 44.5% year-on-year, reaching 450 million yuan, with total revenue increasing by 38.7% year-on-year to 530 million yuan. This was primarily due to a continuous rise in drug sales and income from global business development (BD). The inclusion of orelabrutinib (brand name: InnoCare®) as a first-line treatment for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) in national insurance led to rapid scaling, while maintaining exclusive indication advantages in marginal zone lymphoma. Additionally, the commercialization of tafasitamab (brand name: Minocure®) and zolbetuximab (brand name: InnoCarexin®) brought new growth increments.
The company achieved its first annual profit in 2025, and continued to post profits in Q1 2026, with net profit soaring by 607.7% year-on-year to reach 100 million yuan...
1
At the 2026 American Association for Cancer Research (AACR) Annual Meeting, InnoCare Pharma (SSE code: 688428; HKEX code: 09969) announced preclinical data for its self-developed novel antibody-drug conjugate (ADC) targeting B7-H3, ICP-B794.
This research achievement was published in poster form at the AACR Annual Meeting (Abstract Code: LB355). ICP-B794 is a novel innovative ADC targeting B7-H3, utilizing innovative linker-payload technology to demonstrate potent anti-tumor activity in preclinical tumor models while offering a significantly wider safety window than similar drugs. A Phase I dose escalation clinical trial is currently underway.
ADCs are hailed as 'biological missiles' for precision tumor targeting. ICP-B794 originates from the company's self-developed ADC technology platform, with core advantages including the use of irreversible linkers paired with highly hydrophilic connectors, as well as the incorporation of a new potent payload. This greatly enhances tumor-killing effects while improving the stability and safety of the ADC drug.
Experimental data shows that ICP-B794 maintains a stable drug-to-antibody ratio (DAR) in human plasma, with payloads less prone to premature release, exhibiting significantly superior in vitro anti-tumor activity compared to similar drugs. Preclinical in vivo efficacy results indicate that ICP-B794’s anti-tumor effect is markedly better than other...
This research achievement was published in poster form at the AACR Annual Meeting (Abstract Code: LB355). ICP-B794 is a novel innovative ADC targeting B7-H3, utilizing innovative linker-payload technology to demonstrate potent anti-tumor activity in preclinical tumor models while offering a significantly wider safety window than similar drugs. A Phase I dose escalation clinical trial is currently underway.
ADCs are hailed as 'biological missiles' for precision tumor targeting. ICP-B794 originates from the company's self-developed ADC technology platform, with core advantages including the use of irreversible linkers paired with highly hydrophilic connectors, as well as the incorporation of a new potent payload. This greatly enhances tumor-killing effects while improving the stability and safety of the ADC drug.
Experimental data shows that ICP-B794 maintains a stable drug-to-antibody ratio (DAR) in human plasma, with payloads less prone to premature release, exhibiting significantly superior in vitro anti-tumor activity compared to similar drugs. Preclinical in vivo efficacy results indicate that ICP-B794’s anti-tumor effect is markedly better than other...
Columns InnoCare Pharma achieves profitability, removing special identifier 'U' for unprofitable companies
InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced that its 2025 financial performance meets the relevant criteria for initial profitability set for unprofitable companies at the time of listing on the STAR Market. Starting from March 27, 2026, the company will officially remove the special stock abbreviation identifier 'U'. This marks the company's transition to profitability, allowing it to graduate from the growth tier of the STAR Market as one of the first batch of companies to 'exit the tier' under this mechanism, entering a track of sustainable growth and development.
The stock abbreviation of InnoCare Pharma will be officially changed from 'InnoCare Pharma-U' to 'InnoCare Pharma', while its A-share stock code 688428 remains unchanged.
The 2025 financial report recently released by InnoCare Pharma shows that the company achieved revenue in 2025, increasing year-on-yearby 135.3%achieving2.37 billion yuan, and in 2025first profit after previous losses, with a net profit of640 million yuan,This strong performance is mainly attributed to the continuous commercial scaling and global business development (BD) income.
2025 marks the tenth anniversary milestone for InnoCare Pharma, as well as a key year for achieving rapid growth and completing various strategic objectives.The company achieved profitability for the first time after losses, with two new innovative drugs approved for market launch. The commercialization of core products continued to gain momentum, globalization accelerated, and pipeline R&D achieved breakthroughs across multiple fronts. The company has been advancing into the new phase of 2.0 development by achieving several 'firsts in China'.This demonstrates the strong capability to transform technological innovation into long-term sustainable growth.
Relevant analysis indicates...
The stock abbreviation of InnoCare Pharma will be officially changed from 'InnoCare Pharma-U' to 'InnoCare Pharma', while its A-share stock code 688428 remains unchanged.
The 2025 financial report recently released by InnoCare Pharma shows that the company achieved revenue in 2025, increasing year-on-yearby 135.3%achieving2.37 billion yuan, and in 2025first profit after previous losses, with a net profit of640 million yuan,This strong performance is mainly attributed to the continuous commercial scaling and global business development (BD) income.
2025 marks the tenth anniversary milestone for InnoCare Pharma, as well as a key year for achieving rapid growth and completing various strategic objectives.The company achieved profitability for the first time after losses, with two new innovative drugs approved for market launch. The commercialization of core products continued to gain momentum, globalization accelerated, and pipeline R&D achieved breakthroughs across multiple fronts. The company has been advancing into the new phase of 2.0 development by achieving several 'firsts in China'.This demonstrates the strong capability to transform technological innovation into long-term sustainable growth.
Relevant analysis indicates...
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