Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announces the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor..

信达生物制药集团（“信达生物”）（港交所代码：01801），一家致力于开发、生产和销售用于治疗肿瘤、自身免疫、心血管和代谢疾病、眼科疾病及其他主要疾病的高质量药物的世界级生物制药公司，宣布其非共价（可逆）布鲁顿酪氨酸激酶（BTK）抑制剂Jaypirca®（pirtobrutinib）已获得中国国家药品监督管理局（NMPA）批准，用于治疗既往至少接受过一种包含布鲁顿酪氨酸激酶（BTK）抑制剂的系统治疗的成人慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）患者的新适应症。

Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).1,2 Pirtobrutinib received approval from the U.S.

Pirtobrutinib是一种高选择性激酶抑制剂，它利用一种新颖的非共价结合机制，延长了在之前接受过共价BTK抑制剂（如ibrutinib、acalabrutinib或zanubrutinib）治疗的CLL/SLL患者中靶向BTK通路的益处。Pirtobrutinib已获得美国批准。

FDA in January 2023 as a non‑covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor..

2023年1月，FDA批准了作为一种非共价（可逆）BTK抑制剂。2024年10月，吡托布替尼在中国获批作为单药疗法，用于治疗既往至少接受过两种系统治疗（包括布鲁顿酪氨酸激酶[BTK]抑制剂）的复发性或难治性套细胞淋巴瘤（MCL）成年患者。

The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL‑321 study. BRUIN CLL‑321 is the world’s first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator’s choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab).

该新适应症的批准基于国际多中心随机III期BRUIN CLL-321研究的结果。BRUIN CLL-321是全球首个在既往接受过共价BTK抑制剂（cBTKi）治疗的CLL/SLL患者中进行的随机III期试验。该研究共纳入238例患者，评估了pirtobrutinib单药治疗与研究者选择的IdelaR（idelalisib联合利妥昔单抗）或BR（苯达莫司汀联合利妥昔单抗）的疗效和安全性。

The results demonstrated that pirtobrutinib significantly prolonged median progression‑free survival (PFS) compared with the investigator’s choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment‑related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.3.

结果显示，与研究者选择的方案相比，皮托布替尼显著延长了中位无进展生存期（PFS）（14.0个月 vs 8.7个月；风险比 [HR] = 0.54）。此外，因治疗相关不良事件导致的停药率在皮托布替尼组较低（5.2% vs 21.1%），进一步证明了其在先前接受过共价BTK抑制剂治疗的患者中的疗效和耐受性优势。

Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL‑321 study in China, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, “BTK inhibitors have become the preferred first‑ or second‑line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis.

中国医学科学院血液学研究所血液病医院邱录贵教授表示：“BTK抑制剂已成为CLL/SLL患者首选的一线或二线治疗方案，但部分患者仍然会出现疾病进展，预后较差。邱录贵教授是BRUIN CLL-321研究在中国的主要研究者。

Studies have shown that the median overall survival for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months.4 Therefore, there is an urgent clinical need for new treatment. As a next‑generation, non‑covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL.

研究表明，患者停用共价 BTK 抑制剂后的中位总生存期仅为约 22.7 个月。4 因此，临床上对新的治疗方法有着迫切的需求。作为一种下一代非共价、可逆的 BTK 抑制剂，pirtobrutinib 代表了复发或难治性 CLL 患者治疗的重要进展。

The BRUIN CLL‑321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long‑term disease management in the future.”.

BRUIN CLL‑321 研究证明了其在 CLL/SLL 中的治疗潜力。我们相信，它将为中国 CLL/SLL 患者提供重要的治疗选择，并有助于满足未来长期疾病管理的需求。”

Dr. Li Wang, Lilly Corporate Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, states, “The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option.

礼来公司高级副总裁、礼来中国药物研发及医学事务中心负责人王莉博士表示：“pirtobrutinib在中国获批用于CLL/SLL适应症，这标志着中国CLL/SLL患者的治疗旅程迈出了重要的一步。这意味着共价BTK抑制剂治疗后疾病仍然进展的患者现在可以及时获得这一全球创新的治疗选择。

Supported by the efficacy and safety demonstrated in the BRUIN CLL‑321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting‑edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival.

基于BRUIN CLL-321研究中展现的有效性和安全性，我们很高兴为中国存在显著未满足医疗需求的CLL/SLL患者群体提供一种新的治疗选择。展望未来，礼来将继续致力于加速引入前沿疗法，帮助中国血液恶性肿瘤患者实现更长、更高质量的生存。

This is our enduring commitment to patients in China.”.

这是我们对中国患者的持久承诺。

Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, “Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation.

信达生物制药肿瘤研发高级副总裁周辉博士表示：“Jaypirca（pirtobrutinib）是一种新一代非共价（可逆）BTK抑制剂，为既往接受过共价BTK抑制剂治疗的患者提供了新的治疗选择。CLL/SLL适应症在中国的获批，标志着这一领域取得了重要突破，也确保了中国的CLL/SLL患者能够及时从这项全球治疗创新中获益。”

We will fully leverage Innovent's leading brand presence and commercialization capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need.'.

我们将充分利用信达在肿瘤领域的领先品牌影响力和商业化能力，加速这一创新疗法的可及性，从而让更多有需要的癌症患者获益。"

About BRUIN CLL-321

关于BRUIN CLL-321

BRUIN CLL-321 is a Phase 3, randomized, open-label study of Jaypirca versus investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in covalent Bruton tyrosine kinase (BTK) inhibitor pre-treated patients with relapsed and refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

BRUIN CLL-321 是一项三期、随机、开放标签的研究，比较了Jaypirca与研究者选择的艾代拉利司加利妥昔单抗（IdelaR）或苯达莫司汀加利妥昔单抗（BR）在先前接受过共价布鲁顿酪氨酸激酶（BTK）抑制剂治疗的复发性和难治性慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者中的效果。

The trial enrolled 238 patients, who were randomized 1:1 to receive Jaypirca (200 mg orally, once daily) or investigator's choice of either IdelaR or BR per labeled doses. This trial's primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC).

该试验招募了238名患者，他们以1:1的比例随机分配接受Jaypirca（200毫克口服，每日一次）或研究者选择的IdelaR或BR（按标签剂量）。该试验的主要终点是根据2018年国际慢性淋巴细胞白血病研讨会（iwCLL）标准评估的无进展生存期（PFS），由盲态独立审查委员会（IRC）进行评估。

Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO).  .

次要终点包括研究者评估的无进展生存期 (PFS)；总缓解率 (ORR) 和缓解持续时间 (DoR)；无事件生存期；总生存期 (OS) 和至下一次治疗的时间 (TTNT)；安全性和耐受性；以及患者报告的结果 (PRO)。

About Jaypirca (pirtobrutinib)

关于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), non-covalent (reversible) inhibitor of the enzyme BTK.2 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).5,6.

Jaypirca（pirtobrutinib，前称 LOXO-305）（发音为 jay-pihr-kaa）是一种高选择性（在临床前研究中，对 BTK 的选择性比 98% 的其他测试激酶高出 300 倍）、非共价（可逆）的 BTK 酶抑制剂。BTK 是一个经过验证的分子靶点，在多种 B 细胞白血病和淋巴瘤中存在，包括套细胞淋巴瘤（MCL）和慢性淋巴细胞白血病（CLL）。

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

在中国，礼来公司开发了pirtobrutinib，并由信达生物在大陆进行商业化。

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

关于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes.7 In China, chronic lymphocytic leukemia (CLL) represents approximately 6%–7% of non-Hodgkin lymphoma cases.8 SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells.

慢性淋巴细胞白血病 (CLL) 和小淋巴细胞淋巴瘤 (SLL) 是由称为淋巴细胞的白细胞发展而来的缓慢生长型非霍奇金淋巴瘤。在中国，慢性淋巴细胞白血病 (CLL) 约占非霍奇金淋巴瘤病例的 6%–7%。从病理和免疫表型角度来看，SLL 与 CLL 相同，它们之间的主要区别在于癌细胞的位置不同。

In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes.7.

在CLL中，癌细胞存在于血液中，而在SLL中，癌细胞存在于淋巴结中。

About Innovent

关于信达

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.

信达生物是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。该公司发现、开发、制造和商业化针对一些最棘手疾病的创新药物。其开创性疗法治疗癌症、心血管和代谢、自身免疫和眼科疾病。

Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center..

信达生物已将18款产品推向市场，另有4项资产处于3期或关键性临床试验阶段，15种分子处于早期临床阶段。信达生物与超过30家全球医疗保健公司建立了合作关系，包括礼来、赛诺菲、Incyte、LG化学以及MD安德森癌症中心。

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..

信达恪守“诚信为本，行动致胜”的理念，坚持最高行业标准，合作共进，推动生物医药行业发展，让一流药物广为可及。欲了解更多信息，请访问www.innoventbio.com，或在Facebook和LinkedIn上关注信达。

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

声明：信达不建议使用任何未经批准的药物/适应症。

Forward-Looking Statements

前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与信达相关的“预期”、“相信”、“估计”、“预计”、“意图”等词语及类似表达旨在识别其中某些前瞻性陈述。

Innovent does not intend to update these forward-looking statements regularly..

信达生物并不打算定期更新这些前瞻性声明。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict.

这些前瞻性声明是基于信达生物管理层在作出这些声明时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并非对未来发展的保证，且受风险、不确定性和其他因素的影响，其中一些因素超出信达生物的控制范围并且难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、信达的竞争环境以及政治、经济、法律和社会状况的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息存在重大差异。

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

信达、信达的董事及员工（a）不承担纠正或更新本网站中包含的前瞻性陈述的义务；且（b）不对任何未能实现或最终不正确的前瞻性陈述承担责任。

Contact:

联系人：

Media:

媒体：

pr@innoventbio.com

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+86 512-6956 6088

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Investors:

投资者：

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ir@信达生物.com

+86 512-6956 6088

+86 512-6956 6088

References

参考文献

Source: innoventbio.com

来源：innoventbio.com