Shanghai Henlius Biotech Announces Regulatory Approval of HANBEIYOU in China for Breast Cancer Treatment
Key Points for Investors
- Regulatory Milestone: HANBEIYOU (pertuzumab injection), developed by Shanghai Henlius Biotech, has received official approval from China’s National Medical Products Administration (NMPA) for the treatment of HER2-positive early and metastatic breast cancer.
- Comprehensive Indication Coverage: Approval covers both neoadjuvant/adjuvant use in early-stage disease and first-line treatment in metastatic settings, aligning with all indications of the reference pertuzumab product in China.
- Clinical & Analytical Validation: HANBEIYOU’s approval is based on robust comparative studies, demonstrating high similarity with the reference drug in quality, safety, and efficacy, underlining its status as a true biosimilar.
- International Expansion: HANBEIYOU is not only approved in China, but has also secured regulatory approvals in the US (FDA), European Union (EC), and its applications have been accepted in Canada. The product meets EU GMP manufacturing standards.
- Market Opportunity: Pertuzumab product sales in mainland China reached approximately RMB2.728 billion in 2025, representing a substantial commercial opportunity for Henlius as it launches HANBEIYOU in this market.
- Strategic Impact: The launch of HANBEIYOU will substantially enrich Henlius’s commercial oncology portfolio in China, strengthen its leadership in the breast cancer treatment segment, and potentially drive significant revenue growth.
Detailed Announcement
Shanghai Henlius Biotech, Inc. (Stock Code: 2696) has announced a major regulatory breakthrough with the approval of its HANBEIYOU (pertuzumab injection) by the National Medical Products Administration (NMPA) in China. This approval enables the company to market its biosimilar for the following indications:
- Early Breast Cancer: In combination with trastuzumab and chemotherapy, HANBEIYOU is approved for:
- Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early breast cancer (tumors >2cm or node-positive) as part of a complete early breast cancer regimen.
- Adjuvant treatment for HER2-positive early breast cancer patients at high risk of recurrence.
- Metastatic Breast Cancer: In combination with trastuzumab and docetaxel, HANBEIYOU is indicated for patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Approval Basis and Product Details
The regulatory decision is underpinned by a comprehensive set of analytical, pharmacokinetic, and clinical studies comparing HANBEIYOU to the reference pertuzumab. These demonstrated equivalent quality, safety, and efficacy, confirming HANBEIYOU’s biosimilar status.
Product Details:
- Common Name: Pertuzumab injection
- Trade Name: HANBEIYOU (also known as POHERDY® in the US)
- Specification: 420 mg (14 ml)/vial
- Manufacturer: Shanghai Henlius Biologics Co., Ltd.
- Approval Number: Guo Yao Zhun Zi S20260034
Notably, HANBEIYOU’s international regulatory achievements highlight Henlius’s global ambitions:
- New Drug Submissions accepted in Canada (May 2025)
- GMP certificates received from Belgian authorities for EU compliance (June 2025)
- FDA approval in the US (November 2025)
- Marketing approval by the European Commission (April 2026)
Market and Strategic Implications
The HER2-positive breast cancer market in China is significant, with pertuzumab sales reaching RMB2.728 billion in 2025. The introduction of HANBEIYOU brings a credible, high-quality biosimilar to this lucrative and fast-growing segment. This is expected to:
- Expand Henlius’s product offering and market share in oncology, particularly in breast cancer.
- Provide more affordable and accessible treatment options for Chinese patients.
- Potentially drive strong revenue growth and enhance the company’s leadership position in the field.
The company’s board, led by Chairman Wenjie Zhang, sees this as a pivotal development that could positively impact profitability and shareholder value, especially given the product’s alignment with international regulatory and manufacturing standards.
Shareholder Considerations & Price-Sensitive Aspects
- This approval directly increases Henlius’s revenue potential in China’s breast cancer market.
- International regulatory successes and EU GMP certification may further boost investor confidence in Henlius’s global competitiveness and operational quality.
- Given the scale of the Chinese pertuzumab market, this launch could be a material share price catalyst.
- Investors should monitor HANBEIYOU’s commercial uptake and any future regulatory milestones in additional regions.
Board Composition: The announcement also details the current board members, including executive, non-executive, and independent directors, which reflects a robust and diversified leadership structure.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or consult professional advisors before making investment decisions. The information is based on the company’s public announcement and may be subject to further updates or clarifications.
上海復宏漢霖宣佈漢貝優獲中國批准用於乳腺癌治療
投資者重點
- 監管里程碑：由上海復宏漢霖自主研發的漢貝優（帕妥珠單抗注射液）已獲中國國家藥品監督管理局（NMPA）正式批准用於HER2陽性早期及轉移性乳腺癌治療。
- 全面適應症覆蓋：本次批准涵蓋新輔助/輔助早期乳腺癌及轉移性乳腺癌一線治療，與中國參比帕妥珠單抗全部適應症一致。
- 臨床與分析驗證：漢貝優獲批基於嚴謹的對比性研究，證明其在品質、安全性和有效性與原研藥高度相似，屬於真正的生物類似藥。
- 國際拓展：漢貝優不僅在中國獲批，亦已於美國（FDA）、歐盟（EC）獲批，並完成加拿大申報及取得比利時GMP認證，符合歐盟標準。
- 市場機遇：2025年內地帕妥珠單抗產品銷售額約人民幣27.28億元，漢貝優上市預計將帶來重大商業收入。
- 戰略影響：漢貝優的推出將顯著豐富復宏漢霖在中國腫瘤市場的產品線，鞏固其在乳腺癌領域的領先地位，帶動業績增長。
公告詳情
上海復宏漢霖生物技術股份有限公司（股份代號：2696）公佈，其自主開發的漢貝優（帕妥珠單抗注射液）已獲中國NMPA批准上市，適應症包括：
- 早期乳腺癌：與曲妥珠單抗及化療聯合用藥，適用於：
- HER2陽性、局部晚期、炎症性或早期乳腺癌（腫瘤直徑大於2厘米或淋巴結陽性）患者的新輔助治療。
- 高復發風險HER2陽性早期乳腺癌患者的輔助治療。
- 轉移性乳腺癌：與曲妥珠單抗及多西他賽聯用，治療HER2陽性、轉移性或不可切除局部復發乳腺癌，且未接受過抗HER2治療或化療的患者。
批准依據及產品詳情
本次批准基於與參比藥的全面分析、藥代動力學及臨床對比研究，證明漢貝優在品質、安全性及有效性方面與原研藥高度一致。
產品詳情：
- 通用名：帕妥珠單抗注射液
- 商品名：漢貝優（美國商品名POHERDY®）
- 規格：420毫克（14毫升）/瓶
- 生產企業：上海復宏漢霖生物技術有限公司
- 批准文號：國藥准字S20260034
值得關注的是，漢貝優的國際監管成就突顯公司全球化布局：
- 2025年5月加拿大新藥申報獲受理
- 2025年6月獲比利時GMP證書，符合歐盟GMP標準
- 2025年11月FDA美國上市批准
- 2026年4月歐盟委員會批准上市
市場與戰略影響
2025年中國HER2陽性乳腺癌市場規模達27.28億元。漢貝優的上市將：
- 擴展公司在腫瘤領域特別是乳腺癌的產品組合與市場份額
- 為中國患者提供更可負擔及可及性的治療選擇
- 有望推動公司收入增長，鞏固領先地位
董事會主席張文傑認為，這是促進公司盈利能力和股東價值的關鍵發展，尤其是產品符合國際監管及製造標準。
股東注意事項及股價敏感因素
- 本次批准直接提升公司在中國乳腺癌市場的收入潛力。
- 國際監管成功及歐盟GMP認證有望提升投資者對公司全球競爭力信心。
- 考慮到中國帕妥珠單抗市場規模，漢貝優上市具備成為公司股價催化劑的潛力。
- 建議投資者關注漢貝優的市場推進情況及未來其他地區的監管進展。
董事會組成：公告同時披露現時董事會成員，包括執行、非執行及獨立非執行董事，顯示公司治理結構多元穩健。
免責聲明：本文僅供參考，並不構成投資建議。投資者應自行研究或諮詢專業顧問作投資決策。信息基於公司公開公告，如有進一步更新或澄清，請以公司最新公告為準。
