2026 ASH Oral Presentation | InnoCare Announces Phase III Results of Orelabrutinib in ITP Study Meet Primary Endpoint

BEIJING, Nov. 05, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that results from the Phase III study of orelabrutinib, its novel BTK inhibitor, in chronic primary immune thrombocytopenia (ITP) have been selected for oral presentation at the 2026 Annual Meeting of the American Society of Hematology (ASH). The abstract is now available on the official ASH website.

The Phase III study of orelabrutinib in adult patients with chronic ITP met its primary endpoint. The study demonstrated that orelabrutinib induced rapid and durable platelet responses, reduced the need for rescue therapy, and confirmed the drug’s safety over the full treatment period, which will offer a better treatment option for ITP patients.

Oral presentation

Orelabrutinib, an oral BTK inhibitor, for previously treated chronic primary immune thrombocytopenia in Chinese adults: A phase 3, placebo-controlled, multicenter trial (Abstract Number : abs26-2333)

A total of 196 participants were randomized in a 2:1 ratio to once-daily oral orelabrutinib 50 mg (n=131) or placebo (n=65) for a 24-week double-blind treatment period. The primary endpoint was durable response, defined as a platelet count of ≥50×10⁹/L for 4 of the 6 scheduled visits during the final 12 weeks of the double-blind period without rescue therapy.

The results showed that the Phase III study of orelabrutinib in patients with chronic ITP met its primary endpoint. The orelabrutinib group achieved a durable response rate of 32.8%, representing an improvement of 25.5% over the placebo group (P=0.0001).

The study results also met multiple secondary efficacy endpoints. Orelabrutinib demonstrated rapid response for ITP patients. Orelabrutinib group showed rapid efficacy in ITP patients, with significant superiority over placebo as early as day 7 post-treatment initiation. Among responders, orelabrutinib shortened the median time to initial platelet response to 14 days, compared with 42 days for placebo. Moreover, orelabrutinib significantly reduced the need for rescue therapy.

Orelabrutinib was safe and well tolerated in all participants. The safety profile was comparable to that of placebo, with no obvious evidence of elevated safety risk. Most treatment-emergent adverse event (TEAEs) were grade 1–2.

Data from the Phase III study of orelabrutinib in ITP will be presented in an oral session at the 68th Annual Meeting of ASH. Details are as follows:

Date & Time: December 14, 2026, 14:45–15:00 (Central Standard Time, CST)

Location: Room 217–219, Ernest N. Morial Convention Center (MCCNO)

Presenter: Prof. Yu Hou

The NDA submission for orelabrutinib in ITP was accepted in China, marking the first NDA acceptance for orelabrutinib in autoimmune diseases and a significant milestone in expanding its use beyond hematologic malignancies into autoimmune diseases.

ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet count. ITP ranges in severity from asymptomatic thrombocytopenia to life-threatening hemorrhage, which can substantially affect patients' quality of life. With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need.

The 2026 ASH Annual Meeting, one of the world’s premier conferences in hematology, will be held in New Orleans, USA, from December 12 to 15, 2026.

About InnoCare Pharma

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.