復(fù)宏漢霖與Organon共同宣布?xì)W洲首個(gè)帕妥珠單抗生物類似藥POHERDY獲歐盟委員會(huì)批準(zhǔn) |...

來(lái)源：市場(chǎng)資訊

（來(lái)源：正心谷資本）

復(fù)宏漢霖

中國(guó)上海 & 美國(guó)新澤西州澤西市，2026年4月29日 —— 復(fù)宏漢霖（2696.HK）與Organon（紐交所代碼：OGN）聯(lián)合宣布，歐盟委員會(huì)（European Commission, EC）已批準(zhǔn)POHERDY?（帕妥珠單抗）420 mg/14 mL靜脈注射液的上市許可。該產(chǎn)品是歐洲首個(gè)且目前唯一獲批的PERJETA（帕妥珠單抗）生物類似藥，獲批適用于參比制劑的全部適應(yīng)癥1。

Organon副總裁、全球生物類似藥商業(yè)負(fù)責(zé)人Joe Azzinaro表示：“作為歐洲首個(gè)且目前唯一獲批的帕妥珠單抗生物類似藥，POHERDY的獲批標(biāo)志著在提升特定HER2陽(yáng)性乳腺癌患者治療可及性方面邁出了重要一步。乳腺癌是女性中最常見的惡性腫瘤之一，也是歐盟女性癌癥相關(guān)死亡的主要原因2,3。Organon不斷豐富的生物類似藥全球產(chǎn)品組合，進(jìn)一步彰顯了我們?cè)谥С轴t(yī)療體系可持續(xù)發(fā)展的同時(shí)，持續(xù)推動(dòng)女性健康、提升優(yōu)質(zhì)藥物可及性的堅(jiān)定承諾3,4。”

復(fù)宏漢霖高級(jí)副總裁、首席商務(wù)發(fā)展官曹平表示：“繼POHERDY在美國(guó)獲批成為該市場(chǎng)首個(gè)帕妥珠單抗生物類似藥之后，此次在歐盟獲批進(jìn)一步拓展了我們?cè)谌蚴袌?chǎng)的生物類似藥產(chǎn)品布局，也體現(xiàn)了我們與Organon穩(wěn)固而富有成效的合作關(guān)系。在堅(jiān)持科學(xué)嚴(yán)謹(jǐn)與產(chǎn)品質(zhì)量的基礎(chǔ)上，我們將持續(xù)致力于為患者提供更多的治療選擇、提升可及性，造福患者并助力醫(yī)療體系的可持續(xù)發(fā)展。”

在歐洲，POHERDY適用于聯(lián)合曲妥珠單抗和多西他賽，用于治療既往未接受抗HER2治療或針對(duì)轉(zhuǎn)移性疾病化療的HER2陽(yáng)性轉(zhuǎn)移性或局部復(fù)發(fā)且不可切除的乳腺癌成人患者。此外，POHERDY還可聯(lián)合曲妥珠單抗及化療用于：（i）高復(fù)發(fā)風(fēng)險(xiǎn)的HER2陽(yáng)性局部晚期、炎性或早期乳腺癌成人患者的新輔助治療；（ii）高復(fù)發(fā)風(fēng)險(xiǎn)的HER2陽(yáng)性早期乳腺癌成人患者的輔助治療。

POHERDY的獲批基于對(duì)一整套完整數(shù)據(jù)資料的審評(píng)，包括結(jié)構(gòu)與功能分析數(shù)據(jù)、臨床藥代動(dòng)力學(xué)（PK）數(shù)據(jù)以及對(duì)比性臨床研究。這些研究從整體證據(jù)（totality of evidence）出發(fā)，涵蓋分析、藥代動(dòng)力學(xué)、療效、安全性及免疫原性（即生物制劑引發(fā)免疫反應(yīng)的內(nèi)在能力）等多個(gè)方面，充分證明POHERDY在各項(xiàng)關(guān)鍵指標(biāo)上均與參比制劑高度相似5。

2022年，復(fù)宏漢霖與Organon達(dá)成許可與供應(yīng)協(xié)議，授予Organon包括POHERDY在內(nèi)的多款生物類似藥在中國(guó)以外全球范圍內(nèi)的獨(dú)家商業(yè)化權(quán)利6。

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖（2696.HK）是一家國(guó)際化創(chuàng)新生物制藥企業(yè)，致力于為全球患者提供高品質(zhì)、可負(fù)擔(dān)的生物藥，產(chǎn)品覆蓋腫瘤、自身免疫疾病、眼科疾病等領(lǐng)域。自2010年成立以來(lái)，公司已構(gòu)建涵蓋全球研發(fā)、臨床、注冊(cè)、生產(chǎn)及商業(yè)化的全產(chǎn)業(yè)鏈平臺(tái)，擁有全球員工近4,000人，并在中國(guó)、美國(guó)和日本等多地設(shè)有運(yùn)營(yíng)及分支機(jī)構(gòu)。依托生物類似藥形成的穩(wěn)健現(xiàn)金流反哺創(chuàng)新研發(fā)，復(fù)宏漢霖正穩(wěn)步邁入“全球化2.0”階段，持續(xù)打造可復(fù)制、可持續(xù)的全球增長(zhǎng)模式。截至2026年初，公司共有10款產(chǎn)品在全球60余個(gè)國(guó)家和地區(qū)獲批上市，其中7款已在中國(guó)獲批。在歐美主流生物藥市場(chǎng)，復(fù)宏漢霖亦取得多項(xiàng)里程碑式突破，已有4款產(chǎn)品獲得美國(guó)FDA批準(zhǔn)、5款產(chǎn)品獲得歐盟EC批準(zhǔn)，充分體現(xiàn)了公司在研發(fā)體系、質(zhì)量管理及生產(chǎn)能力方面已全面對(duì)標(biāo)國(guó)際最高標(biāo)準(zhǔn)。

在創(chuàng)新驅(qū)動(dòng)方面，復(fù)宏漢霖依托上海、美國(guó)等多地協(xié)同布局的研發(fā)體系，構(gòu)建了多元化、平臺(tái)化的創(chuàng)新技術(shù)矩陣，覆蓋免疫檢查點(diǎn)抑制劑、免疫細(xì)胞銜接器（包括多特異性TCE）、抗體偶聯(lián)藥物（ADC）以及AI驅(qū)動(dòng)的早期研發(fā)平臺(tái)等前沿方向。目前，公司擁有50余項(xiàng)處于早期階段的創(chuàng)新資產(chǎn)，其中約70%具備同類最佳（Best-in-Class）潛力，并在全球同步推進(jìn)30余項(xiàng)臨床研究。核心產(chǎn)品H藥 漢斯?fàn)?（斯魯利單抗，歐洲商品名：Hetronifly?）作為全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗，正加速全球布局，已在全球40余個(gè)市場(chǎng)獲批上市；同時(shí)，多款潛力創(chuàng)新資產(chǎn)，包括PD-L1 ADC HLX43及新表位HER2單抗HLX22正全面推進(jìn)全球關(guān)鍵性臨床研究。依托通過中、歐、美三地GMP認(rèn)證的生產(chǎn)體系，復(fù)宏漢霖已建成總產(chǎn)能達(dá)84,000升的生物藥生產(chǎn)平臺(tái)，形成覆蓋全球六大洲的穩(wěn)定供應(yīng)網(wǎng)絡(luò)。未來(lái)，復(fù)宏漢霖將始終堅(jiān)持以患者為中心，聚焦未滿足的臨床需求，持續(xù)推動(dòng)創(chuàng)新成果向臨床價(jià)值與患者可及轉(zhuǎn)化，在全球生物醫(yī)藥創(chuàng)新生態(tài)中創(chuàng)造長(zhǎng)期而穩(wěn)健的價(jià)值。

關(guān)于Organon

Organon（紐約證券交易所代碼：OGN）是一家全球化醫(yī)療健康公司，以提供創(chuàng)新性的藥品和解決方案，實(shí)現(xiàn)更健康的每一天為使命。Organon在全球提供超過70種藥物和醫(yī)療解決方案，并持續(xù)推動(dòng)這些亟需療法在超140個(gè)市場(chǎng)的廣泛可及，重點(diǎn)業(yè)務(wù)包括女性健康與包括生物類似藥在內(nèi)的經(jīng)典產(chǎn)品，專注于為女性特有疾病、對(duì)女性影響重大或不同的疾病尋求解決方案。

Organon總部設(shè)在美國(guó)新澤西州澤西市，致力于提升醫(yī)藥健康領(lǐng)域的可及性、可負(fù)擔(dān)性和創(chuàng)新發(fā)展。訪問 www.organon.com，并關(guān)注我們的 LinkedIn、Instagram、X、YouTube、TikTok 和 Facebook以了解更多有關(guān)Organon的信息。

關(guān)于前瞻性聲明的注意事項(xiàng)

本新聞稿包含《1995年美國(guó)私人證券訴訟改革法案》（US Private Securities Litigation Reform Act of 1995）安全港條款所界定的“前瞻性聲明”，包括但不限于有關(guān)POHERDY的治療目標(biāo)，以及Organon通過提供優(yōu)質(zhì)藥物、在促進(jìn)女性健康的同時(shí)持續(xù)支持醫(yī)療體系可持續(xù)發(fā)展的相關(guān)承諾。前瞻性聲明通常可通過“將”、“計(jì)劃”、“持續(xù)”、“致力于支持”、“可能”等詞語(yǔ)及類似表達(dá)加以識(shí)別。上述聲明基于Organon管理層當(dāng)前的信念和預(yù)期，受到多項(xiàng)重大風(fēng)險(xiǎn)和不確定性的影響。若相關(guān)假設(shè)被證明不準(zhǔn)確，或相關(guān)風(fēng)險(xiǎn)或不確定性發(fā)生，實(shí)際結(jié)果可能與前瞻性聲明中所述存在重大差異。可能導(dǎo)致實(shí)際結(jié)果與前瞻性聲明存在重大差異的因素，可參見Organon向美國(guó)證券交易委員會(huì)（SEC）提交的文件，包括其最新的Form 10-K年度報(bào)告及其他相關(guān)披露文件，詳見SEC官方網(wǎng)站（www.sec.gov）。除非法律另有要求，Organon不承擔(dān)因新信息、未來(lái)事件或其他原因而對(duì)任何前瞻性聲明進(jìn)行公開更新的義務(wù)。

PERJETA 是 F. Hoffmann-La Roche AG 在歐盟注冊(cè)的商標(biāo)；Organon 與該商標(biāo)所有者沒有任何關(guān)聯(lián)。

European Commission (EC) Approves Henlius and Organon’s POHERDY? (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe

SHANGHAI, China & JERSEY CITY, NJ – April 29, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY? (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1

“As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women and the leading cause of cancer related deaths among women in the European Union,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 “Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines.”3,4

“Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system.”

In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).5

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly? in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about POHERDY treatment goals and Organon’s ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicine. Forward-looking statements may be identified by words such as “will,” “plan,” “ongoing,” “commitment to supporting,” “may,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

PERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG; Organon is not associated with this trademark owner.

參考文獻(xiàn)

References

1. PERJETA. Product Information. Genentech, Inc.; 2025.

2. Breast cancer in the EU. European Commission, Joint Research Centre. October 2023. Accessed April 14, 2026. https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_Breast_cancer_2022_Oct_2023.pdf

3. European Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency (EMA). Last Updated October 29, 2019. Accessed April 14, 2026. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

4. Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; January 2025. Accessed April 14, 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf

5. Biosimilar medicines: overview. European Medicines Agency (EMA). April 2, 2025. Accessed April 14, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview

6. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta ?(Pertuzumab) and Prolia ?/Xgeva ?(Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed April 14, 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/