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InnoCare Pharma Ltd. A

InnoCare Pharma Limited is a biopharmaceutical company that discovers, develops, and commercializes drugs for cancer and autoimmune diseases in China. Its lead drug, Orelabrutinib, is a BTK inhibitor being developed for relapsed and/or refractory (r/r) chronic lymphocytic leukemia, r/r mantle cell lymphoma, r/r Waldenstrom's macroglobulinemia, r/r marginal zone lymphoma, r/r diffuse large B-cell lymphoma (DLBCL)-MCD, r/r central nervous system lymphoma, in combination with MIL-62, systemic lupus erythematosus, immune thrombocytopenia purpura, multiple sclerosis, and neuromyelitis optica spectrum disorder. The company is also developing ICP-B02 for CD20+ B-cell malignancies, ICP-B05 for hemato-oncology and solid tumors, ICP-248 for chronic lymphocytic leukemia, ICP-332 for atopic dermatitis, ICP-488 for psoriasis, ICP-538 for autoimmune diseases, zurletrectinib (ICP-723) for neurotrophic tyrosine receptor kinase fusion positive cancers, and ICP-189 for non-small cell lung cancer. Incorporated in 2015, InnoCare Pharma Limited is headquartered in Beijing, China.

Price · split & dividend adjusted

Why is InnoCare Pharma Ltd. A (688428.CG) moving?

Latest
▲4

InnoCare's pipeline wins and first-half profit mark a turning point

  • Orelabrutinib Phase 3 data published, confirming best-in-class profile Published Phase 3 results show orelabrutinib cut the risk of CLL/SLL worsening or death by 68% versus older chemo-immunotherapy, with a strong safety profile. It is already approved and reimbursed in China, so this backs up existing sales and makes future growth more believable.

    Confirms the core marketed drug's clinical strength, supporting revenue durability.

  • Two TYK2 inhibitors hit Phase 3 goals in skin diseases Soficitinib met its main goal in a Phase 3 atopic dermatitis trial, and fadeucravacitinib did the same in plaque psoriasis. Both are oral drugs for large, chronic skin conditions, so success widens the company's future revenue beyond its blood-cancer drugs.

    Adds two new late-stage assets that could become major future sellers.

  • Mesutoclax combination gets fast-track status and Phase 3 clearance China's drug regulator gave the orelabrutinib-mesutoclax combo Breakthrough Therapy Designation in lymphoma, and cleared a head-to-head Phase 3 trial of mesutoclax plus azacitidine in newly diagnosed AML. Faster reviews and a pivotal trial shorten the path to new approvals.

    Regulatory acceleration de-risks and speeds up a key next-generation pipeline drug.

  • First-half 2026 results show 55.5% revenue growth and a profit Revenue rose 55.5% to RMB 1.1 billion and the company swung to a RMB 239.7 million profit, helped by orelabrutinib and new launches. With about RMB 8.4 billion in cash, it can fund its pipeline without needing to raise money soon.

    The profit turnaround and cash pile are the clearest sign the business is now self-funding.

Q3 2026
▲4

InnoCare's pipeline wins and first-half profit mark a turning point

  • Orelabrutinib Phase 3 data published, confirming best-in-class profile Published Phase 3 results show orelabrutinib cut the risk of CLL/SLL worsening or death by 68% versus older chemo-immunotherapy, with a strong safety profile. It is already approved and reimbursed in China, so this backs up existing sales and makes future growth more believable.

    Confirms the core marketed drug's clinical strength, supporting revenue durability.

  • Two TYK2 inhibitors hit Phase 3 goals in skin diseases Soficitinib met its main goal in a Phase 3 atopic dermatitis trial, and fadeucravacitinib did the same in plaque psoriasis. Both are oral drugs for large, chronic skin conditions, so success widens the company's future revenue beyond its blood-cancer drugs.

    Adds two new late-stage assets that could become major future sellers.

  • Mesutoclax combination gets fast-track status and Phase 3 clearance China's drug regulator gave the orelabrutinib-mesutoclax combo Breakthrough Therapy Designation in lymphoma, and cleared a head-to-head Phase 3 trial of mesutoclax plus azacitidine in newly diagnosed AML. Faster reviews and a pivotal trial shorten the path to new approvals.

    Regulatory acceleration de-risks and speeds up a key next-generation pipeline drug.

  • First-half 2026 results show 55.5% revenue growth and a profit Revenue rose 55.5% to RMB 1.1 billion and the company swung to a RMB 239.7 million profit, helped by orelabrutinib and new launches. With about RMB 8.4 billion in cash, it can fund its pipeline without needing to raise money soon.

    The profit turnaround and cash pile are the clearest sign the business is now self-funding.

News & notes moving 688428.CG
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Biotech & Genomic Medicine▲

Eli Lilly Wins Two FDA Approvals and a $3.35 Billion InnoCare Alliance

Eli Lilly received FDA approval for Olumiant to treat pediatric patients with severe alopecia areata, and the agency also cleared once weekly insulin Onswik for adults with type 2 diabetes, adding a new dosing option. Separately, Eli Lilly agreed a global drug discovery alliance with InnoCare Pharma valued at up to US$3.35b in research and licensing commitments. The Olumiant label extension moves an existing medicine into a younger, severe-disease population, while Onswik adds a once weekly insulin option in type 2 diabetes based on QWINT Phase 3 data. Investors will be watching the pace of U.S. uptake once Onswik KwikPen launches in its two strengths, any disclosed milestones or target selections under the InnoCare agreement, and progress updates around BRAVE AA PEDS beyond Week 36.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Demand
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Regulation
688428.CG · Capital · Positive InnoCare Pharma entered a global drug discovery alliance with Eli Lilly valued at up to US$3.35b in research and licensing commitments.
LLY · Capital · Positive Eli Lilly agreed a global drug discovery alliance with InnoCare valued at up to US$3.35b in research and licensing commitments.
LLY · Regulation · Positive FDA approved Olumiant for pediatric severe alopecia areata and cleared once-weekly insulin Onswik for type 2 diabetes.
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Biotech & Genomic Medicine▲2impact 4

InnoCare Signs Licensing Deal With Eli Lilly Worth Up to $3.35B

InnoCare Pharma has entered a research collaboration and license agreement with Eli Lilly to develop new medicines, the companies said on Thursday. Under the deal, InnoCare will use its drug discovery platform and research to discover and advance compounds against up to five targets. InnoCare is eligible to receive up to $100M in upfront and near-term payments, plus milestone-based payments of up to $3.25B contingent on development and commercial achievements. The company will also be eligible for single-digit tiered royalties based on annual net product sales.
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Biotech & Genomic Medicine › AI Drug Discovery Competition
688428.CG · Capital · Positive InnoCare signs licensing deal with Eli Lilly worth up to $3.35B, including up to $100M upfront and $3.25B in milestones plus royalties.
LLY · Capital · Positive Eli Lilly signs licensing deal with InnoCare worth up to $3.35B to develop new medicines against up to five targets.
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China
Biotech & Genomic Medicine▲

InnoCare Gets China Approval for First Bispecific ADC Trial

InnoCare Pharma announced that China's drug regulator has approved its Investigational New Drug application to begin clinical trials for ICP-B381, a novel bispecific antibody-drug conjugate targeting PSMA and STEAP1 for solid tumors including prostate cancer. This marks InnoCare's first bispecific ADC to enter the clinic and its third ADC overall. In preclinical studies, ICP-B381 showed robust antitumor activity in a prostate cancer model, outperforming single-target ADCs. No bispecific ADC targeting these proteins has been approved globally yet.
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Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) Competition
688428.CG · Technology · Positive China's regulator approved InnoCare's IND to begin clinical trials for its first bispecific ADC, ICP-B381, advancing its pipeline.
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Biotech & Genomic Medicine

China Approves J&J's Psoriasis Drug Icotide

U.S. pharmaceutical giant Johnson & Johnson (J&J) announced on the 27th that Chinese drug regulators have approved its oral psoriasis treatment Icotide. China has more than 8.4 million psoriasis patients, and in this market, J&J's Tremfya, Bristol-Myers Squibb's Sotyktu, and AbbVie's Skyrizi are among the competitors. Analysts point out that Icotide, as a once-daily oral medication, could become a blockbuster and take market share from injectables. Icotide is approved for the treatment of moderate to severe plaque psoriasis, and Chinese companies such as InnoCare Pharma and Takeda are also developing oral treatments.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Competition
JNJ · Regulation · Positive Chinese regulators approved J&J's oral psoriasis drug Icotide, opening a large market opportunity.
ABBV · Competition · Negative J&J's newly approved oral Icotide could take market share from AbbVie's Skyrizi in China's psoriasis market.
BMY · Competition · Negative J&J's Icotide approval adds oral competition to Bristol-Myers Squibb's Sotyktu in China.
688428.CG · Competition · Neutral InnoCare is noted as also developing oral psoriasis treatments, implying future competition but no concrete impact.
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Biotech & Genomic Medicine▲7

InnoCare Pharma Reports 55.5% Revenue Growth and Profit Turnaround in First Half of 2026

InnoCare Pharma announced its interim results for the first half of 2026, reporting a 55.5% year-on-year revenue increase to RMB 1.1 billion and a profit of RMB 239.7 million, a turnaround from a loss in the same period last year. Drug sales grew 43.2% to RMB 918.1 million, driven by orelabrutinib and new launches of tafasitamab and zurletrectinib. The company achieved multiple milestones, including NDA approval for orelabrutinib in Australia, NDA acceptances for orelabrutinib in ITP and zurletrectinib in pediatric solid tumors, and Phase III primary endpoint successes for two TYK2 inhibitors, soficitinib and fadeucravacitinib. InnoCare also initiated three Phase III trials and received IND approvals for three new drug candidates, while its cash balance stood at approximately RMB 8.4 billion as of June 30, 2026.
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Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
688428.CG · Capital · Positive Reports 55.5% revenue growth and profit turnaround, with strong drug sales and pipeline progress.
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ChinaUnited StatesAustralia
Biotech & Genomic Medicine▲2

InnoCare's mesutoclax combination therapy approved to initiate registrational Phase III clinical trial

InnoCare announced that its self-developed novel BCL2 inhibitor mesutoclax in combination with azacitidine, head-to-head versus venetoclax plus azacitidine for the treatment of elderly or unfit newly diagnosed acute myeloid leukemia, has been approved by the Center for Drug Evaluation of the National Medical Products Administration to initiate a registrational Phase III clinical trial. This is a randomized, open-label, multicenter registrational Phase III study with overall survival as the primary endpoint. Mesutoclax has received two breakthrough therapy designations from the CDE in China. Data released at ASCO in May this year showed that the composite complete remission rate of mesutoclax combined with azacitidine in AML was 81.8 percent, 86.5 percent of patients achieving overall response reached minimal residual disease negativity, 83 percent of cCR patients achieved cCR in the first cycle, the early mortality rate was zero, and the 6-month overall survival rate at the recommended dose was 90.5 percent. InnoCare co-founder, chairman and CEO Cui Jisong said this is an important milestone in the clinical development of mesutoclax, and clinical trials of this combination therapy in the United States and Australia have successfully enrolled patients and are being accelerated.
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Biotech & Genomic Medicine › Oncology Therapeutics Competition
688428.CG · Technology · Positive Approval to initiate registrational Phase III trial for mesutoclax combination therapy, a key clinical milestone.
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Biotech & Genomic Medicine▲2

InnoCare's Orelabrutinib and Mesutoclax Combination Wins Breakthrough Therapy Designation in China

InnoCare Pharma announced that its combination of orelabrutinib and mesutoclax has received Breakthrough Therapy Designation from China's Center for Drug Evaluation for treating marginal zone lymphoma patients who have received at least one prior therapy. This marks the second Breakthrough Therapy Designation for mesutoclax, a novel BCL2 inhibitor that was previously the first in its class to earn the designation in China for mantle cell lymphoma. Data presented at the 2026 ASCO Annual Meeting showed the combination achieved a 100% overall response rate in previously treated MZL patients. The designation is intended to accelerate clinical development and approval of drugs demonstrating significant clinical advantages for life-threatening conditions.
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Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
688428.CG · Technology · Positive Breakthrough Therapy Designation for orelabrutinib/mesutoclax combination accelerates development and approval for MZL.
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Biotech & Genomic Medicine▲2impact 4

InnoCare's TYK2 Inhibitor Fadeucravacitinib Meets Primary Endpoint in Phase III Psoriasis Study

InnoCare announced that its independently developed novel TYK2 inhibitor Fadeucravacitinib, also known as ICP-488, has met the primary endpoint in a Phase III registrational clinical study for the treatment of moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled, multicenter study showed highly statistically significant and clinically meaningful improvements on the primary endpoint, and also met multiple secondary endpoints, with all efficacy evaluation indicators demonstrating consistent and significant therapeutic effects. The safety profile was consistent with previous studies, with no new safety signals identified. Detailed data will be presented at an international academic conference or published in a journal. Fadeucravacitinib is an oral, highly selective TYK2 allosteric inhibitor, and indications currently under development also include autoimmune diseases such as cutaneous lupus erythematosus and Sjögren's syndrome. Dr. Jasmine Cui, co-founder, chairperson, and CEO of InnoCare, stated that the company will accelerate subsequent research and initiate marketing applications as soon as possible, aiming to provide a more effective, safe, and convenient oral treatment option for psoriasis patients.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Competition
688428.CG · Technology · Positive Phase III success for its TYK2 inhibitor Fadeucravacitinib in psoriasis, meeting primary endpoint with strong efficacy and safety.
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Biotech & Genomic Medicine▲5

InnoCare's Soficitinib Meets Primary Endpoint in Phase II Vitiligo Study

InnoCare's self-developed next-generation highly selective oral TYK2 inhibitor soficitinib has successfully met the primary endpoint in the Phase II stage of a Phase II/III adaptive clinical trial for patients with non-segmental vitiligo. Data at week 24 showed that the facial vitiligo area scoring index decreased by 38.8 percent from baseline in the once-daily 80 milligram dose group, by 41.2 percent in the 120 milligram dose group, and by 2.2 percent in the placebo group, with statistically significant differences. The treatment was well tolerated and no new safety signals were identified.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Competition
688428.CG · Technology · Positive Soficitinib met primary endpoint in Phase II vitiligo study with significant efficacy and good safety.
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Biotech & Genomic Medicine▲impact 4

InnoCare Phase 3 Data Published in STTT Show Orelabrutinib Cuts CLL/SLL Progression Risk by 68%

InnoCare Pharma announced the publication of Phase 3 results in Signal Transduction and Targeted Therapy showing orelabrutinib significantly prolonged progression-free survival in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma. The study, with a hazard ratio of 0.32, demonstrated a 68% reduction in the risk of disease progression or death compared to chemoimmunotherapy. Orelabrutinib achieved an overall response rate of 90.1% versus 79.2% in the control group, with a complete response rate of 12.1% at 30-month follow-up and a duration of response hazard ratio of 0.30. The safety profile was favorable, with most treatment-related adverse events being Grade 1-2 and no treatment-related atrial fibrillation, major bleeding, or second primary malignancies observed, despite a median treatment duration nearly four times longer than the control group. Orelabrutinib is already approved for first-line CLL/SLL in China and was included in the National Reimbursement Drug List in 2025.
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Biotech & Genomic Medicine › Oncology Therapeutics Competition
688428.CG · Technology · Positive 奥布替尼一线治疗CLL/SLL III期结果发表于STTT,PFS显著延长,疾病进展或死亡风险降低68%,已获批并纳入医保。
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Biotech & Genomic Medicine▲

InnoCare Doses First Patient in China Trial of Novel CDH17 ADC ICP-B208

InnoCare Pharma announced that the first patient has been dosed in the clinical trial of its novel CDH17 targeted antibody-drug conjugate ICP-B208 in China. ICP-B208 is developed from InnoCare’s in-house ADC platform and comprises a humanized anti-CDH17 monoclonal antibody conjugated to a potent, in-house invented payload via a protease-cleavable linker, designed for enhanced tumor-killing effects with improved stability and safety. CDH17 is a calcium-dependent cell adhesion protein involved in tumor cell proliferation, migration, and metastasis, and its tumor-restricted expression makes it an attractive target for treating gastrointestinal cancers such as colorectal, gastric, pancreatic ductal adenocarcinoma, and biliary tract cancer, with no approved CDH17 targeted ADCs currently available globally. This marks the clinical development progress of InnoCare’s second ADC drug, following ICP-B794, a novel ADC targeting B7-H3.
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Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) Competition
688428.CG · Technology · Positive First patient dosed in clinical trial of novel ADC ICP-B208, advancing pipeline.
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Biotech & Genomic Medicine▲

Pharmaceutical Stocks Surge: Shouyao Holdings and Gan & Lee Pharmaceuticals Hit Daily Limit Up

The pharmaceutical sector rallied strongly during trading on the 6th, with weight-loss drug and innovative drug concepts standing out. Shouyao Holdings and Gan & Lee Pharmaceuticals were among multiple stocks that hit their daily limit up. As of press time, Shouyao Holdings surged by the 20 percent daily limit, Hotgen Biotech rose about 14 percent, Mabwell Bioscience, InventisBio, and Shanghai Yizhong Pharmaceutical gained over 10 percent, Gan & Lee Pharmaceuticals, Huahai Pharmaceutical, and Menovo Pharmaceutical also hit their daily limit up, BeiGene and Pharmaron climbed over 7 percent, and Hengrui Medicine advanced more than 5 percent. In the Hong Kong market, Duality Biologics, InnoCare Pharma, and Sino Biopharmaceutical rose over 10 percent, while WuXi XDC and Pharmaron gained more than 5 percent. On the news front, the National Medical Products Administration is soliciting public comments on optimizing the review and approval of cell and gene therapy drugs, encouraging clinically value-oriented R&D innovation, focusing on key areas such as malignant tumors and rare diseases, and placing eligible drugs into a 30-day review and approval pathway. Meanwhile, the overseas expansion of innovative drugs is accelerating. Since 2026, the total value of China's innovative drug license-out deals has reached 94.3 billion US dollars, up 81 percent year-on-year, with upfront payments reaching 5.5 billion US dollars, up 124 percent year-on-year, reflecting growing overseas recognition of China's innovative drug pipeline. CICC noted that leading innovative drug companies are shifting from the R&D investment phase into a positive cycle of commercial scale-up and overseas licensing revenue realization.
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Biotech & Genomic Medicine › Gene & Cell Editing ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
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Biotech & Genomic Medicine › Tools, Diagnostics & CDMO ▲Demand
688197.CG · Demand · Positive Shouyao Holdings surged by 20% daily limit up, leading the sector rally driven by regulatory encouragement for innovative drugs and strong overseas licensing data.
688197.CG · Regulation · Positive Surged by 20% daily limit up, leading the rally driven by NMPA's solicitation of comments on optimizing drug review and accelerating overseas licensing.
603538.CG · Demand · Positive Menovo Pharmaceutical hit daily limit up amid sector rally driven by positive regulatory news and strong overseas licensing data.
603538.CG · Regulation · Positive Mentioned as hitting daily limit up amid sector rally driven by NMPA's solicitation of comments on optimizing cell and gene therapy drug review, encouraging innovation.
688062.CG · Demand · Positive Mabwell Bioscience gained over 10% as part of the pharmaceutical sector surge, supported by regulatory encouragement for innovative drugs and growing overseas licensing.
688062.CG · Regulation · Positive Gained over 10% as part of sector rally on NMPA's policy support for innovative drugs.
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