Tafasitamab-Cxix

2026年6月22日，中国北京——北京市科学技术委员会、中关村科技园区管理委员会近日公布了2026年北京市重点实验室认定名单。由诺诚健华作为依托单位，联合北京肿瘤医院（北京大学肿瘤医院）、北京大学未来技术学院分子医学研究所、北京天诚医药共同申报的“新型抗体及多功能偶联药物研发北京市重点实验室”成功获批。这是继和清华大学携手获批“口服药物智能设计与递送北京市重点实验室”后，诺诚健华成功获批的第二个北京市重点实验室。 “新型抗体及多功能偶联药物研发北京市重点实验室”体现了产学研医四位一体的深度融合，致力于加速创新药源头创新。实验室整合了诺诚健华及合作伙伴的核心科研力量，涵盖疾病治疗新机制和新靶点发现、新型抗体药物研发、多功能偶联药物技术开发、临床转化与应用研究等多重维度。 实验室致力于突破新型抗体及偶联药物领域的关键核心技术瓶颈，研究方向包括新型抗体筛选与工程化改造、多功能偶联药物设计与优化、AI赋能药物研发、临床前评价与临床转化等。 诺诚健华开发了高度差异化的 ADC技术平台，采用独有的连接子-有效载荷 （LP） 技术，旨在为癌症治疗提供有效且有针对性的疗法。靶向B7-H3 的新型ADC创新药ICP-B794和靶向CDH17的新型ADC创新药ICP-B208正在加速临床开发，旨在为实体瘤患者带来更好的治疗选择。 北京市重点实验室是北京市科技创新体系的重要组成部分，承担着培养使用优秀创新人才、开展高水平科研活动、推动重大科技成果转化的重要使命。 关于诺诚健华 诺诚健华（上交所代码：688428；香港联交所代码：09969）是一家商业化阶段的生物医药高科技公司，致力于成为为全世界患者开发及提供创新疗法的全球生物医药行业领导者。公司聚焦具有广阔市场空间的恶性肿瘤与自身免疫性疾病领域，解决未被满足的临床需求。诺诚健华已搭建了一体化新药创制平台，并打造了丰富的产品管线，包括三款获批上市的创新药（奥布替尼、坦昔妥单抗和佐来曲替尼）、十多款临床阶段的创新药以及多个临床前项目。公司在北京、南京、上海、广州、香港和美国设有分支机构。欲了解更多公司信息，请访问官网 https://www.innocarepharma.com ， 并关注我们的微信号：诺诚健华INNOCARE。 前瞻性声明 本新闻稿含有一些前瞻性声明的披露。除对事实的陈述以外，所有其他声明可被看作是前瞻性声明，即关于我们或者我们的管理部门打算、期望、计划、相信或者预期将会或者可能会在未来发生的行为、事件或者发展所做出的声明。此类声明是我们的管理部门根据其经验和对历史趋势、当前条件、预期未来发展和其他相关因素的认知，做出的假设与估计。该前瞻性声明并不能保证未来的业绩，实际的结果，发展和业务决策可能与该前瞻性声明的设想不符。我们的前瞻性声明同样受到大量的风险和不确定性因素的制约，这可能会影响我们的近期以及长期的业绩表现。

WILMINGTON, Del.--(BUSINESS WIRE)-- $INCY --Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi ® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). “This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer.” DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant. 1 The approval is based on results from the MOR208C203 Trial: L-MIND (NCT02399085), an international Phase II trial, and INCMOR 0208-102 Trial Part 4 (Group 6): J-MIND (NCT04661007), a domestic Phase Ib/II trial in Japan, both of which evaluated the safety and efficacy of Minjuvi in combination with lenalidomide in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). 2,4 In the L-MIND trial, based on an independent review committee assessment (data cutoff date: November 20, 2018), the overall response rate (ORR) was 58.8% (primary endpoint), with a complete response (CR) rate of 41.3% and a partial response (PR) rate of 17.5%. 3 The median duration of response (mDOR) had not been reached at a median follow-up of 44 months or more. 3 Furthermore, based on the independent review committee’s assessment in the J-MIND trial (data cutoff date: August 31, 2023), the response rate was 71.4%, with a complete response (CR) rate of 45.2% and a partial response (PR) rate of 26.2%. 4 The main adverse events included neutropenia and thrombocytopenia. 4,5 Overall, Minjuvi in combination with lenalidomide demonstrated a clinically meaningful response, and the side effects were manageable. 4,5 This approval represents the second regulatory approval for Minjuvi in Japan. Minjuvi in combination with rituximab and lenalidomide was previously approved by the MHLW for the treatment of adult patients with relapsed or refractory follicular lymphoma (2L+ FL). About L-MIND L-MIND was a single-arm, open-label Phase 2 study evaluating tafasitamab in combination with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma who had received at least one, but no more than three, prior lines of therapy (including an anti-CD20 therapy such as rituximab) and who were not eligible for, or refused, high-dose chemotherapy followed by autologous stem cell transplant. 2 The primary endpoint was overall response rate; secondary endpoints included duration of response, progression-free survival, and overall survival. 2 For more information about the study, please visit . About J-MIND J-MIND Trial Part 4 (Group 6) (NCT04661007) is a Japanese Phase Ib/II clinical trial evaluating the efficacy and safety of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients enrolled in this trial had received one to three prior systemic therapies, including CD20-targeted therapy, and were deemed by the principal investigator to be ineligible for or unresponsive to autologous hematopoietic stem cell transplantation. 4 The primary endpoint of this trial was the objective response rate (ORR) as assessed by an independent review committee based on the Lugano criteria; secondary endpoints included complete response (CR), progression-free survival (PFS), and overall survival (OS). 4 For more information about the study, please visit . About Minjuvi ® (tafasitamab) Minjuvi ® (tafasitamab) is a humanized, Fc-modified, cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi ® (tafasitamab-cxix) received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). 6 Additionally, Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). 6 In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. 7 Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one line of systemic therapy in Europe. 7 In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Japan. 8 Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). XmAb ® is a registered trademark of Xencor, Inc. Monjuvi and Minjuvi are registered trademarks of Incyte. Important Safety Information Please refer to the Minjuvi Product Information (PI) for indications, dosage and administration, precautions, and safety information in Japan, as well as the Pharmaceuticals and Medical Devices Agency (PMDA) website . About Incyte ® Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity. To learn more, visit Incyte.com and Investor.Incyte.com . Follow us on social media: LinkedIn , X and Instagram . Incyte Biosciences Japan G.K. is a wholly owned subsidiary of Incyte. For more information about Incyte in Japan, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential for Minjuvi to provide a new treatment option for patients in Japan with DLBCL, and Incyte’s aspirations and goals as set forth under the heading “About Incyte.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including Incyte’s ability to demonstrate the efficacy and safety of its products and product candidates; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition; and sales, marketing, manufacturing, and distribution requirements, as well as the risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements. _________________________ 1 Sehn LH, Salles G. Diffuse large B-cell lymphoma. N Engl J Med. 2021;384:842–858. Link to source ( ) 2 ClinicalTrials.gov. Open label study to evaluate the safety and efficacy of lenalidomide with MOR00208 in patients with R-R DLBCL (L-MIND). Link to source ( ). Accessed June 2026. 3 Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024;109(2):553–566. Link to source ( ) 4 Izutsu K, Fukuhara N, Yuda J, Suehiro Y, Kusumoto S, Casadebaig ML, Suzukawa K, Fukushima K. Tafasitamab as Monotherapy or in Combination in Japanese Patients With B-Cell Non-Hodgkin Lymphoma: Results From the Phase 1b J-MIND Study. Cancer Sci. 2026 Apr;117(4):1093–1105. Link to source ( ) 5 Salles G, Duell J, González-Barca E, et al. Tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, Phase 2 study. Lancet Oncol. 2020;21:978–988. Link to source ( (20)30225-4/abstract ) 6 U.S. Food and Drug Administration. Monjuvi ® (tafasitamab-cxix) Prescribing Information. Accessed June 2026. Link to source ( ). 7 European Medicines Agency (EMA). Minjuvi (tafasitamab) European Public Assessment Report (EPAR) and Product Information. Accessed June 2026. Link to source ( ). 8 Incyte. Minjuvi ® (tafasitamab) Product Information (Japan) and Pharmaceuticals and Medical Devices Agency (PMDA) electronic package insert. Accessed June 2026. Link to source ( ). 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