2021-04-16

復宏漢霖免疫檢查點抑制劑又添新成員,創新型抗LAG-3單抗IND申請獲NMPA批准


2021年4月15日,複宏漢霖(2696.HK)宣佈,企业自主開發的HLX26(重組抗LAG-3人源化單克隆抗躰注射液)的臨床試驗申請獲得國家藥品監督管理局(NMPA)準予,有望用於實體瘤及淋巴瘤的治療。


淋巴細胞活化基因3(Lymphocyte-activation gene 3,LAG-3)是一種免疫檢查點受體蛋白,被視為繼PD-1/L1、CTLA-4後新一代的免疫治療靶點,全球現時暫無該靶點產品上市。 多項臨床研究資料顯示,LAG-3抑制劑在肺癌、乳腺癌、黑色素瘤和頭頸癌等多種實體瘤和血液腫瘤中均有明顯的疾病控制效果,已有III期臨床研究顯示其與PD-1抑制劑聯用可協同增强免疫應答,具有廣闊的腫瘤治療應用前景。



LAG-3主要在活化的T細胞和部分NK細胞等人體免疫細胞表面表達,與配體結合後,對T細胞的增殖、活化和穩態等起負調節作用-1。 HLX26作為靶向LAG-3胞外結構域的人源化單抗,可阻斷LAG-3介導的負訊號通路,使T細胞重新獲得細胞毒性活性,從而恢復對腫瘤的殺傷功能。 臨床前研究表明,HLX26具有抗腫瘤活性以及良好的耐受性和安全性,尤其是在體外實驗和動物模型中,HLX26與企业創新型PD-1抑制劑HLX10聯用顯示出了明顯的腫瘤抑制作用,具有協同效應。 臨床前研究結果為HLX26後續開展臨床試驗提供了科學依據,該產品有望在實體瘤和淋巴瘤治療領域發揮重要作用,拓展企业疾病治療領域。

現時,複宏漢霖已在PD-1/L1、CTLA-4、LAG-3等免疫檢查點全面佈局,為免疫聯合治療的探索創造更多可能。 未來企业將依託豐富的靶點開發經驗和一體化研發平臺,積極開發更多被市場所需要的創新型產品,打造出高品質、可負擔且具有差异化優勢的創新產品管線。 报错 笔记


關於複宏漢霖
複宏漢霖(2696.HK)是一家國際化的創新生物製藥企业,致力於為全球患者提供可負擔的高品質生物藥,產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域,已在中國上市3款產品,在歐盟上市1款產品,2款產品獲得中國上市註冊申請受理。 自2010年成立以來,複宏漢霖已建成一體化生物製藥平臺,高效及創新的自主核心能力貫穿研發、生產及商業運營全產業鏈。 企业已建立完善高效的全球研發中心,按照國際GMP標準進行生產和質量管控,位於上海徐匯的生產基地已獲得中國和歐盟GMP認證。

複宏漢霖前瞻性佈局了一個多元化、高品質的產品管線,涵蓋20多種創新單克隆抗躰,並全面推進基於自有抗PD-1單抗HLX10的腫瘤免疫聯合療法。 繼國內首個生物類似藥漢利康 ® (利妥昔單抗)、中國首個自主研發的中歐雙批單抗藥物漢曲優 ® (曲妥珠單抗,歐盟商品名:Zercepac ®)、 企业首個自身免疫疾病治療產品漢達遠 ® (阿達木單抗)相繼獲批上市,企业HLX04貝伐珠單抗及HLX01利妥昔單抗類風濕關節炎新適應症的上市註冊申請也正在審評中。 企业亦同步就10個產品、8個聯合治療方案在全球範圍內開展20多項臨床試驗,對外授權全面覆蓋歐美主流生物藥市場和眾多新興國家市場

Henlius Received IND Approval for Its Novel Anti-LAG-3 mAb HLX26 from NMPA

Shanghai, China, April 15, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody injection) has been approved by the National Medical Products Administration (NMPA) for treatment of solid tumors and lymphomas.?

Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor and is regarded as a new generation of immunotherapy target after PD-1/L1 and CTLA-4. Currently, there is no LAG-3 targeted product on the market around the globe. A number of clinical studies have shown that LAG-3 inhibitors have obvious disease control effects in many solid tumors and hematological malignancy such as lung cancer, breast cancer, melanoma, head and neck cancer. A Phase III clinical study suggests that targeting the LAG-3 pathway in the combination with PD-1/L1 pathway effectively activates immune response, demonstrating the promising prospect of this product.

LAG-3 is an immune checkpoint receptor that is mainly expressed on human immune cells including activated T cells and part of NK cells, and negatively regulats the proliferation, activization and homeostasis of T cells-1. HLX26 is a human mAb targeting LAG-3 extracellular domains, can block the LAG-3-mediated signaling pathway to restore the killing function of T-cell. Pre-clinical studies have proved that HLX26 has anti-tumor effect and favourable tolerability and safety. Particular in in vitro and animal model studies, HLX26 combined with Henlius’ proprietary anti-PD-1 mAb HLX10 creates synergistic effects in anti-tumor. These results lay the foundation for further clinical studies. HLX26 is expected to play an important role in the treatment of solid tumors and lymphomas, and expand the Company’s ?therapeutic area.

At present, Henlius has built an all-round layout of the immune checkpoint products of PD-1/L1, CTLA-4 and LAG-3, etc., creating more opportunities for the exploration of combination immunotherapy. Looking forward, the Company will rely on extensive target development experience and integrated R&D platform actively developing more innovative products for patients, and build a high-quality, affordable and differentiated innovative product pipeline.

About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDA) of 2 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Apart from the launched products 漢利康 ® (rituximab), the first China-developed biosimilar, 漢曲優 ® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 漢達遠 ® (adalimumab), the Company's first product indicated for autoimmune diseases, the NDA of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review. What's more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.

【參考文獻】
[1] Ruffo E, Wu R C, Bruno T C, et al. Lymphocyte-activation gene 3 (LAG3): the next immune checkpoint receptor[C]//Seminars in immunology. Academic Press, 2019, 42: 101305.
[2] Solinas C, Migliori E, De Silva P, et al. LAG3: the biological processes that motivate targeting this immune checkpoint molecule in human cancer[J]. Cancers, 2019, 11(8): 1213.

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