Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announced that the China National Medical Products Administration (NMPA) has approved Jaypirca^® (pirtobrutinib, 100 mg & 50 mg tablets), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as a monotherapy for the treatment of adult patient with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This NMPA action expands the Jaypirca^® indication to include patients with CLL/SLL across all lines of therapy and regardless of prior covalent BTK inhibitor treatment.

Jaypirca^®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to target the BTK pathway in patients with CLL/SLL. It has been evaluated across multiple clinical studies in patients with CLL/SLL who were either previously treated with a covalent BTK inhibitor or who were BTK inhibitor-naïve, generating clinical evidence supporting its use across different CLL/SLL treatment settings.

The approval is supported by data from the global Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials. BRUIN CLL-313 is the first prospective, randomized Phase 3 study to examine the efficacy and safety of a non-covalent BTK inhibitor in patients with treatment-naïve CLL/SLL. In BRUIN CLL-313, the study demonstrated a statistically significant benefit in independent review committee (IRC)-assessed progression-free survival (PFS) for pirtobrutinib compared with bendamustine plus rituximab (BR) (HR=0.199), representing an 80.1% reduction in the risk of disease progression or death^[1]. BRUIN CLL-314 is the first head-to-head Phase 3 CLL/SLL trial to compare covalent and non-covalent BTK inhibitors in a BTK inhibitor-naïve population, which included relapsed and refractory and treatment-naïve patients. In BRUIN CLL-314, the study met its primary endpoint of noninferiority for overall response rate (ORR) in both the intent-to-treat (ITT) population and previously treated patients. Pirtobrutinib achieved a numerically higher ORR compared to ibrutinib. Although PFS data remain immature, a trend toward PFS benefit was observed^[2]. Together, these two studies support the clinical value of pirtobrutinib across the CLL/SLL treatment continuum.

Prof. Jianyong Li, Principal Investigator of the BRUIN CLL-313 Study in China, said, "BTK inhibitors have significantly transformed the treatment landscape for patients with CLL/SLL in recent years. However, as disease management continues to evolve, there remains a growing need for treatment options that combine durable efficacy with a favorable tolerability profile. As a non-covalent BTK inhibitor, pirtobrutinib has demonstrated meaningful clinical benefit in both treatment-naïve and previously treated patients with CLL/SLL. This approval has the potential to provide a new option for Chinese patients with CLL/SLL across all lines of therapy, meaningfully advancing the management of CLL/SLL throughout the treatment journey."

Prof. Luqiu Qiu, Principal Investigator of the BRUIN CLL-314 Study in China, commented, "With the emergence of non-covalent BTK inhibitors, the treatment landscape for CLL or SLL is rapidly evolving. Pirtobrutinib's novel head-to-head evidence against a covalent BTK inhibitor in a BTK inhibitor-naïve population, may offer an important treatment option for both treatment-naïve and relapsed or refractory patients, regardless of prior covalent BTK inhibitor treatment."

"This approval marks another significant milestone in the collaboration between Innovent and Lilly, reflecting our shared commitment to bringing innovative therapies to patients with hematologic malignancies in China, said Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent. "As a non-covalent BTK inhibitor, Jaypirca^® offers an important treatment option across the full spectrum of CLL/SLL therapy. The approval across lines of therapy further validates the clinical value of pirtobrutinib in CLL/SLL. We will continue to leverage Innovent's professional commercial capabilities in oncology to accelerate patient access to this innovative therapy, to offer Jaypirca^® to more Chinese patients with CLL/SLL who may benefit from this treatment."

Dr. Li Wang, Lilly Corporate Senior Vice President and Head of Lilly China Drug Development and Medical Affairs Center, said, "The approval of an expanded indication for Jaypirca^® in CLL/SLL marks an important milestone for Lilly's ongoing efforts in China to advance innovation for patients with hematologic malignancies. Supported by the robust evidence generated from the BRUIN clinical program, this additional approval for Jaypirca^® expands its potential to reach a broader population of patients with CLL/SLL who may benefit. Across all treatment lines, from relapsed or refractory disease to the frontline setting, we hope to help patients achieve better disease management and improve quality of life. Looking ahead, Lilly remains committed to accelerating the introduction of innovative therapies in China and addressing the unmet needs of patients with hematologic cancers."