BIO第一現場 | 復宏漢霖與Sermonix就拉索昔芬片簽署補充許可協議，擴大...

• 復宏漢霖與Sermonix就拉索昔芬片（HLX78）的合作現已擴展至整個亞洲；

  Sermonix和復宏漢霖將與日本藥品和醫療器械管理局（PMDA）溝通，共同在日本加速開發HLX78；

  近期HLX78在中國獲批開展臨牀，復宏漢霖將啟動ELAINE-3研究在中國的患者招募。

2024年6月7日，復宏漢霖（2696.HK）宣佈和Sermonix簽署了補充許可協議，在雙方原有關於HLX78（拉索昔芬片）的中國區域合作許可協議下，拓展許可市場範圍至整個亞洲。基於該補充協議，復宏漢霖與Sermonix將共同推動HLX78在日本的合作開發。此前，Sermonix已經就HLX78完成一項在日本受試者中開展的臨牀I期藥代動力學研究，雙方計劃與日本藥品和醫療器械管理局（PMDA）就未來藥品上市路徑開展溝通。

上個月，復宏漢霖宣佈，HLX78（拉索昔芬片）獲國家藥品監督管理局（NMPA）臨牀試驗批准，以加入一項在400位ESR1突變的ER+/HER2−乳腺癌患者羣體中評估拉索昔芬片聯合CDK4/6抑制劑抗腫瘤療效的國際多中心3期臨牀研究（ELAINE-3研究，NCT05696626）。

復宏漢霖高級副總裁兼首席商務發展官

曹平女士

復宏漢霖和Sermonix的合作始於2024年1月，從最初的協議簽署到如今的補充協議，短短几個月里，HLX78已在中國遞交臨牀申請並獲得批准，雙方高效的協作與執行力可見一斑。

Sermonix創始人兼首席執行官

David Portman博士

ELAINE-3研究目前正在美國、加拿大、歐盟和以色列積極招募受試者。值此之時，我們很高興看到HLX78在中國獲批開展臨牀試驗。復宏漢霖將啟動ELAINE-3研究在中國的患者招募，從而使我們的患者羣體進一步多樣化，助力造福更多有迫切臨牀需求的患者。

HLX78（lasofoxifene，拉索昔芬片）是復宏漢霖自Sermonix Pharmaceuticals, Inc. 許可引進的一款臨牀階段在研新型內分泌療法，在ESR1突變的ER+/HER2-乳腺癌的治療中具有強大的靶向治療作用。

在已完成的兩項II期臨牀研究（ELAINE-1和ELAINE-2研究）中，針對ESR1突變腫瘤，lasofoxifene作為單藥或聯合CDK4/6抑制劑使用均展現出抗腫瘤活性。從lasofoxifene對雌激素受體突變的生物利用度和藥物活性來看，該候選藥物有望為內分泌治療后產生獲得性耐藥ESR1突變的患者羣體帶來希望，並有望在晚期ER+乳腺癌的精準醫學治療中發揮關鍵作用。

乳腺癌是全球發病率最高的癌症，據GLOBOCAN數據顯示，2020年全球乳腺癌新發病例達226萬，中國乳腺癌新發病例逾41萬^[1]。雌激素受體（Estrogen receptor，ER）陽性乳腺癌佔乳腺癌總數的60%-70%^[2]。內分泌治療是雌激素受體陽性（ER+）乳腺癌的主要治療手段，其中最常使用的芳香化酶抑制劑（aromatase inhibitor，AI）已被美國國立綜合癌症網絡（NCCN）和中國臨牀腫瘤學會（CSCO）等指南推薦成為ER+/HER2-乳腺癌患者的輔助及一線標準治療方法^[3-4]，然而幾乎所有經AI治療的患者會產生原發性或獲得性耐藥^[5]，其中雌激素受體α基因（ESR1）獲得性突變最為常見，高達40%，被認為是內分泌治療重要耐藥機制^[6]，目前針對ESR1突變的ER+/HER2-乳腺癌治療方案有限，存在較大治療需求。

【參考文獻】

[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124.

[3] 《中國臨牀腫瘤學會（CSCO）乳腺癌診療指南2023》

[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.5.2023

[5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1.

[6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579

關於Sermonix

Sermonix Pharmaceuticals Inc. 是一家俬營生物製藥公司，專注於女性特異性腫瘤產品的開發，目前正在圍繞其主要研究藥物lasofoxifene開展一項III期臨牀研究。由創始人David Portman博士帶領的公司管理團隊在乳腺癌領域的藥物開發、監管和商業化過程的全生命周期均擁有豐富經驗。欲瞭解更多信息，請訪問SermonixPharma.com。

關於復宏漢霖

復宏漢霖（2696.HK）是一家國際化的創新生物製藥公司，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5款產品，在國際獲批上市3款產品，23項適應症獲批，3個上市申請分別獲中國藥監局和歐盟EMA受理。自2010年成立以來，復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。公司已建立完善高效的全球創新中心，按照國際藥品生產質量管理規範（GMP）標準進行生產和質量管控，不斷夯實一體化綜合生產平臺，其中，公司商業化生產基地已相繼獲得中國、歐盟和美國GMP認證。

復宏漢霖前瞻性佈局了一個多元化、高質量的產品管線，涵蓋50多個分子，並全面推進基於自有抗PD-1單抗H藥漢斯狀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）、自主研發的中美歐三地獲批單抗生物類似藥漢曲優（曲妥珠單抗，美國商品名：HERCESSI，歐洲商品名：Zercepac）、漢達遠（阿達木單抗）和漢貝泰（貝伐珠單抗）相繼獲批上市，創新產品漢斯狀（斯魯利單抗）已獲批用於治療微衞星高度不穩定（MSI-H）實體瘤、鱗狀非小細胞肺癌、廣泛期小細胞肺癌和食管鱗狀細胞癌，併成為全球首個獲批一線治療小細胞肺癌的抗PD-1單抗。公司亦同步就16個產品在全球範圍內開展30多項臨牀試驗，對外授權全面覆蓋歐美主流生物藥市場和眾多新興市場。

Henlius Expands Collaboration with Sermonix for Lasofoxifene in All of Asia

• The collaboration of lasofoxifene (HLX78) between Henlius and Sermonix now include all of Asia

• Sermonix and Henlius will subsequently engage with PMDA and collaborate on expedited co-development of oral lasofoxifene in Japan

• IND approval in China allows Shanghai Henlius Biotech to enroll ELAINE-3 trial patients in China

SHANGHAI, China - June 7, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) has expanded its license from Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), to add additional Asia territories for HLX78 (oral lasofoxifene). The agreement also allows Henlius to share with Sermonix expedited co-development of HLX78 in Japan. Sermonix has completed a Phase 1 Japanese PK study and, together with Henlius, will begin engagement with the Pharmaceuticals and Medical Devices Agency (PMDA) to address a regulatory path in Japan.

Last month, Henlius announced that China’s National Medical Products Administration (NMPA) approved the investigational new drug application (IND) for HLX78 (oral lasofoxifene). The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China. ELAINE-3 (NCT05696626), the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial, is assessing the efficacy of oral lasofoxifene and a CDK4/6 inhibitor in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

 「The collaboration between Henlius and Sermonix started in January 2024,」 Ms. Ping Cao, Chief Business Development Officer, and SVP of Business Development of Henlius, said, 「In mere months from agreement to amendment, our unified dedication shines, turning swift collaboration and full-hearted implementation into tangible success - as underscored by our product's IND approval in China."

「With active ELAINE-3 enrollment already underway in the U.S., Canada, EU and Israel, we are pleased to announce that Sermonix and Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application,」 said Dr. David Portman, Sermonix founder and chief executive officer. 「This milestone clears Henlius to enroll patients in ELAINE-3 in China, therefore further diversifying our patient population and potentially helping more people to better confront this terrible disease.」

HLX78 (Oral lasofoxifene) is an investigational novel targeted endocrine therapy in clinical development that has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations.

In two completed Phase 2 clinical studies (ELAINE-1 and ELAINE-2), lasofoxifene demonstrated anti-tumor activity against tumors with ESR1 mutations as a monotherapy and in combination with a CDK4/6 inhibitor. Lasofoxifene’s bioavailability and potent activity in mutations of the estrogen receptor, in addition to its potential to improve sexual and urogenital health with a well-tolerated profile, could hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.3 million new cases of breast cancer in 2022 globally, including more than 357,000 in China.1 ER+ breast cancer comprises 60-70% of all breast cancers.2 Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer.3,4 However, almost all patients treated with AIs in the advanced setting develop resistance5, with ESR1 mutations being one of the most prevalent alterations, present in up to 40% of patients and a significant mechanism of resistance to endocrine therapy6. Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists.

About Sermonix

Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes in the breast cancer drug development arena. Learn more at SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com.

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, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. 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 commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.    

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