InnoCare Announces Approval of Orelabrutinib for the First-line Treatment of CLL/SLL in China

April 25, 2025 - InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced today that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). The approval of the first-line CLL/SLL treatment will enable orelabrutinib to benefit an even broader population of lymphoma patients.

Orelabrutinib has been approved for the treatment of three indications in China, including relapsed and refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (R/R MCL) and R/R marginal zone lymphoma (R/R MZL), all of which have been covered in the National Reimbursement Drug List.

Jianyong Li, the principal investigator of the clinical trial and a professor at the Jiangsu Province Hospital, said: “Orelabrutinib has demonstrated excellent efficacy and safety in the treatment of B-cell malignancies such as R/R CLL/SLL since its launch in 2020, showing a higher complete response rate. The first-line approval means more lymphoma patients will benefit from this highly effective treatment regimen. The study showed a complete response rate as high as 12.1%, which will bring new hope to the treatment of hematological tumors in China.”

Lugui Qiu, the principal investigator of the clinical trial and a professor at the Blood Diseases Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College, said, "Despite the challenges posed by the COVID-19 pandemic in initiating the study, enrolling patients and patient management, orelabrutinib demonstrated significant efficacy and good safety in first-line treatment of CLL/SLL. It also provides an effective treatment option for high-risk patients and those with comorbidities, both in clinical research and real-world settings.

Jun Ma, professor at the Harbin Blood Disease and Oncology Research Institute, said, "With the approval of orelabrutinib for first-line CLL/SLL treatment and the accumulation of additional real-world data, more lymphoma patients will benefit. Furthermore, orelabrutinib has been listed as a Class I recommendation for first-line treatment of CLL/SLL in the CSCO lymphoma guidelines. We look forward to more extensive and longer follow-up data on orelabrutinib to guide clinical practice and offer better treatment options for more lymphoma patients.

Jun Zhu, professor at Beijing Cancer Hospital said, "The prospect of orelabrutinib in the treatment of hematological tumors is remarkable. Its high selectivity and low off-target effects give it advantages in both efficacy and safety. We believe that with the extensive use of orelabrutinib in first-line treatment, more patients will benefit from this novel therapy.”

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said: “We are delighted to see the approval of orelabrutinib for the first-line treatment of CLL/SLL. This marks another important milestone for our company in hematological malignancies. We sincerely thank all the physicians, patients and employees who have worked tirelessly on this study. We look forward to bringing new hope and treatment options to more lymphoma patients.”

Orelabrutinib is a novel BTK inhibitor developed by InnoCare. With high target selectivity, it can avoid adverse events related to off-target effects and improve safety and efficacy.

CLL/SLL, one of the most prevalent forms of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are 191,000 newly diagnosed CLL cases each year, with 61,000 related deaths. The incidence rate of CLL/SLL is on the rise in China.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.