Jaypirca® (pirtobrutinib) Approved in China for a New Indication in Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) Across All Lines of Therapy

SAN FRANCISCO and SUZHOU, China, Sept. 28, 2026 /PRNewswire/ — 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."

About BRUIN CLL-313

BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (BR) in people with CLL/SLL without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or BR per labeled doses. BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed ORR, duration of response (DoR), and PFS, overall survival (OS), time to next treatment (TTNT), safety and tolerability and patient-reported outcomes (PRO).

About BRUIN CLL-314

BRUIN CLL-314 is a Phase 3, randomized, open-label noninferiority study of Jaypirca^® (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with CLL/SLL who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial enrolled 662 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is ORR as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed PFS, duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), OS, safety and tolerability, and patient-reported outcomes (PRO).

About Jaypirca^® (Pirtobrutinib)

Jaypirca^® (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies^[3]), non-covalent inhibitor of the enzyme BTK and is the first-and-only approved medicine binding to both wild-type and C481 mutated BTK³. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) ^[4],[5].

In China, pirtobrutinib was developed by Eli Lilly and Company and is commercialized in mainland China by Innovent Biologics.

About Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)

CLL/SLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes^[6],[7]. CLL/SLL is one of the most common types of leukemia in adults^[8]. There are roughly 100,000 new cases of CLL/SLL globally each year, and the overall incidence of CLL/SLL in China is estimated at approximately 0.39 per 100,000 population^[8],[9]. In CLL/SLL, the cancer cells are present in the blood.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the highquality outbound internationalization of China’s innovative drug industry.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:

1) Innovent does not recommend the use of any unapproved drug (s)/indication (s).

2) Ramucirumab (Cyramza^®) and selpercatinib (Retsevmo^®), pirtobrutinib (Jaypirca^®) and abemaciclib (Verzenios^®) were developed by Eli Lilly and Company.

Disclaimer: Innovent does not recommend any off-label usage.

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