2024年3月4日，復宏漢霖（2696.HK）發(fā)布正面盈利預告，根據本公司截至2023年12月31日止年度的未經審核綜合管理賬目及董事會目前可得資料的初步評估，公司預期報告期內將錄得年內利潤不低于人民幣5億元，這是繼首次實現2023半年度盈利之后，公司首次實現全年度盈利。此次盈利主要得益于公司核心產品漢曲優(yōu)®和漢斯狀®的銷售收入持續(xù)增長以及公司精細化管理下的降本增效。
復宏漢霖董事長兼執(zhí)行董事張文杰
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2023年對于復宏漢霖具有里程碑意義，我們首次實現了全年盈利，得益于研產銷一體化的高效協同和疊加效應，公司在整體決策效率和市場響應方面持續(xù)增速，取得了飛躍性的發(fā)展。未來，我們將繼續(xù)精進提質，不斷在高質量發(fā)展中取得新突破，推動公司走向騰飛新高度！
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復宏漢霖執(zhí)行董事、首席執(zhí)行官兼首席財務官朱俊
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復宏漢霖始終以臨床需求為精準導向、以創(chuàng)新研發(fā)為立足之本，在充滿挑戰(zhàn)的市場環(huán)境下，我們保持戰(zhàn)略定力、強化自身差異化優(yōu)勢，在諸多領域不斷實現里程碑突破, 推動業(yè)績里程碑式跨越增長。站在發(fā)展新起點，我們將繼續(xù)探索增長新藍圖，并與產業(yè)鏈合作伙伴攜手，推動創(chuàng)新藥加速造福更多患者。
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高效協同，經營業(yè)績再創(chuàng)新高
2023年，復宏漢霖持續(xù)提升自我 “造血” 能力，憑借前瞻性的商業(yè)化布局和高效的市場拓展，持續(xù)推動產品各項商業(yè)化進程，多維度提升產品可及助力患者更長生存獲益。公司兩款核心產品成為公司營收 “增長極”，國內外市場競爭力持續(xù)增強，加碼公司高質量發(fā)展之路。
漢曲優(yōu)®（曲妥珠單抗，歐洲商品名：Zercepac®，澳大利亞商品名：Tuzucip®/Trastucip®）是中國首個自主研發(fā)的中歐雙批單抗藥物，用于治療HER2陽性早期乳腺癌、轉移性乳腺癌及轉移性胃癌。截至目前，漢曲優(yōu)®已在中國、英國、瑞士、澳大利亞、新加坡、泰國、阿根廷、巴西、沙特阿拉伯等40多個國家和地區(qū)獲批上市，成為獲批上市國家和地區(qū)最多的國產生物類似藥。憑借150mg和60mg雙規(guī)格、不含防腐劑等差異化優(yōu)勢，該產品高速拓展中國市場份額，迄今已惠及超過17萬名中國患者。2023年上半年，該產品美國上市許可申請獲得美國食品藥品監(jiān)督管理局（FDA）受理，有望成為首個在中歐美獲批的國產單抗生物類似藥，同年7月，其在加拿大的上市注冊申請也獲得了加拿大衛(wèi)生部受理，將進一步覆蓋歐美主流生物藥市場。
公司首個創(chuàng)新型單抗H藥 漢斯狀®（斯魯利單抗）于2022年3月獲批上市，目前已獲批用于治療微衛(wèi)星高度不穩(wěn)定（MSI-H）實體瘤、鱗狀非小細胞肺癌（sqNSCLC）、廣泛期小細胞肺癌（ES-SCLC）和食管鱗狀細胞癌（ESCC），并且是全球首個一線治療小細胞肺癌的抗PD-1單抗。2023年12月，H藥第5個適應癥一線治療非鱗狀非小細胞肺癌（nsNSCLC）上市注冊申請獲中國國家藥監(jiān)局（NMPA）受理，有望于2024年下半年獲批。上市以來，H藥以突破性療效和差異化優(yōu)勢，獲得業(yè)內廣泛認可，市場競爭力和影響力不斷提升。截至目前，該產品已完成中國境內所有省份的招標掛網并成功納入逾70個省/城市級惠民保，惠及患者超過5.5萬人。此外，復宏漢霖攜手全球知名制藥企業(yè)，持續(xù)拓展H藥海外版圖，對外授權已覆蓋美國、歐洲、東南亞、中東和北非、印度等國家和地區(qū)。2023年12月，該產品于印度尼西亞獲批上市，成為首個在東南亞國家成功獲批上市的國產抗PD-1單抗。在歐美生物藥市場，H藥針對ES-SCLC的上市申請也已在歐盟獲受理，此外，復宏漢霖還在美國啟動了一項H藥對比一線標準治療阿替利珠單抗用于ES-SCLC的頭對頭橋接試驗，以進一步支持其在美國的申報上市，推動 “中國制造” 走向更廣闊的舞臺。
多維發(fā)力，加快滿足臨床之需
創(chuàng)新是復宏漢霖可持續(xù)發(fā)展的基石。我們始終堅持“以患者為中心”，持續(xù)深化和貫徹差異化的創(chuàng)新戰(zhàn)略，搭建多元化和高品質的產品管線，并加速成果轉化落地。目前，公司產品管線已涵蓋約60個分子，覆蓋單抗、多抗、抗體偶聯藥物（ADC）、融合蛋白、小分子藥物等藥物形式，其中超過80%的產品為自主開發(fā)。2023年，公司在全球范圍內加速推進H藥、HLX11（帕妥珠單抗生物類似藥）、HLX14（地舒單抗生物類似藥）和HLX04-O（抗VEGF單抗）等多個已上市或臨床后期階段產品的國際多中心III期臨床研究，并完成美國、歐盟等國家和地區(qū)的首例受試者給藥。此外，公司積極探索新靶點、新機制，不斷拓展產品疾病領域和新分子類型，全力推進HLX42（EGFR ADC）及HLX43（PD-L1 ADC）等多款潛在first/best-in-class產品進入I期臨床研究階段，并成功獲得多款產品的突破性療法認定和快速通道資格認定，創(chuàng)新產品布局進一步加速。
作為一家國際化的生物制藥企業(yè)，復宏漢霖持續(xù)完善和提升大規(guī)模生產能力，陸續(xù)建立徐匯、松江（一）、松江（二）三大生產基地，形成協同和規(guī)模效應，目前商業(yè)化總產能已達48,000升，實現中國、歐洲、東南亞和部分拉美市場的常態(tài)化供應，2026年有望達到144,000升，為公司中長期全球商業(yè)化生產及業(yè)務發(fā)展構筑堅實基礎。2023年，公司生產基地及質量管理體系密集接受或通過美國、歐盟、藥品檢查合作計劃（PIC/S）成員巴西及印度尼西亞、哥倫比亞等各國藥監(jiān)機構以及國際合作伙伴實施的實地核查或審計，推動公司產品擴容“全球版圖”、造福全球更多患者。
未來，復宏漢霖將繼續(xù)加強創(chuàng)新策源能力、全力推進產能建設、提升產品商業(yè)化效率，夯實企業(yè)正向循環(huán)基本盤，打造多元增長引擎，向著更高的發(fā)展目標鏗鏘邁進。
關于復宏漢霖
復宏漢霖（2696.HK）是一家國際化的創(chuàng)新生物制藥公司，致力于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，在國際上市2款產品，19項適應癥獲批，7個上市申請分別獲中國藥監(jiān)局、美國FDA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制藥平臺，高效及創(chuàng)新的自主核心能力貫穿研發(fā)、生產及商業(yè)運營全產業(yè)鏈。公司已建立完善高效的全球創(chuàng)新中心，按照國際藥品生產質量管理規(guī)范（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，上海徐匯基地和松江基地（一）均已獲得中國和歐盟GMP認證。
復宏漢霖前瞻性布局了一個多元化、高質量的產品管線，涵蓋20多種創(chuàng)新單克隆抗體，并全面推進基于自有抗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）、中國首個自主研發(fā)的中歐雙批單抗藥物漢曲優(yōu)®（曲妥珠單抗，歐洲商品名：Zercepac®，澳大利亞商品名：Tuzucip®和Trastucip®）、漢達遠®（阿達木單抗）和漢貝泰®（貝伐珠單抗）相繼獲批上市，創(chuàng)新產品漢斯狀®（斯魯利單抗）已獲批用于治療微衛(wèi)星高度不穩(wěn)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，并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個產品在全球范圍內開展30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市場。
Henlius Forecasts Profit in 2023: Achieving first full year of profitability, and ushering in a new phase of high-quality development
Shanghai, China, March 4th, 2024 – Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, itis expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company's core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management.
Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and cumulative effects of an integrated industrial chain of R&D, manufacturing, and commercialization, the company has improved its decision-making efficiency and speed-to-market, achieving a leapfrog development. Looking ahead, we will continue to improve quality, make new breakthroughs in our journey of quality development, and reach out toward new horizons.”
Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: “Henlius has always been guided by clinical needs and adheres to an innovation-driven development strategy. We maintain strategic focus and strengthen our own differentiated advantages under challenging circumstances, achieving milestone breakthroughs in various areas, and driving a rapid growth. Standing at a new starting point for development, we will draw a new blueprint for growth and collaborate with partners along the industry chain to benefit more patients.”
Hitting a record high by efficient and seamless collaboration
In 2023, Henlius further enhanced its self-sufficiency capabilities. Leveraging a forward-looking commercial layout and efficient market expansion, the company continuously advanced its product commercialization, improving product accessibility to maximize patient benefit. The competitiveness of the company’s two core products has continued to improve both domestically and internationally, which drives the revenue significantly and contributes to the high-quality development of the company.
HANQUYOU (trastuzumab, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed monoclonal antibody biosimilar approved both in China and Europe, is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. HANQUYOU has become the China-developed biosimilar with the most marketing approvals, covering over 40 countries and regions up to now, including China, the UK, Switzerland, Australia, Singapore, Thailand, Argentina, Brazil, and Saudi Arabia. With its differentiated advantages such as dual dosage of 150mg and 60mg, preservative-free formulation, the product has rapidly expanded its market share in China, benefiting more than 170,000 Chinese patients to date. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA) in the first half of 2023, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S. Furthermore, its New Drug Submission (NDS) was accepted by the Health Canada in July 2023, further expanding the product’s footprint in major markets of biologics in the U.S. and Europe.
HANSIZHUANG (serplulimab), the first anti-PD-1 monoclonal antibody (mAb) developed by Henlius, was launched in March 2022. Up to date, it has been approved for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). It is also the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). In December 2023, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous (NSCLC) was accepted by the National Medical Products Administration (NMPA), with approval expected in the second half of 2024. With its breakthrough efficacy and differentiated advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and has increasingly strengthened its market competitiveness and influence. To date, it has completed tendering process on the procurement platform in all provinces of Chinese mainland and has been included in over 70 provincial/city-level supplementary commercial medical insurances, benefiting more than 55,000 patients. Additionally, Henlius has collaborated with many world-renowned pharmaceutical companies to further expand HANSIZHUANG’s global footprint, which now includes the U.S., Europe, Southeast Asia, MENA, and India. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. On the other hand, HANSIZHUANG’s Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to further support the BLA in the U.S., which encourages more Chinese medicines to go global.
Accelerating the pace to meet the clinical needs in a multi-dimensional manner
Innovation is the cornerstone of Henlius for its sustainable development. We deliver on the commitment to patient centricity and continuously deepen and implement the differentiated innovation strategy to build a diversified and high-quality product pipeline and accelerate the translation of research results to market and practice. Currently, our product pipeline includes about 60 molecules across mAb, polyclonal antibody (pAb), antibody-drug conjugate (ADC), fusion protein, and small molecule drug, of which more than 80% are self-developed. In 2023, the company accelerated global multicentre phase 3 clinical studies for marketed or late clinical-stage products, including HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with the first patients dosed in the U.S., the EU and other countries and regions. Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, promoting a number of potential first/best-in-class products, including the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43, to enter into the phase 1 clinical research. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products, further accelerating its innovation layout.
As a global biopharmaceutical company, Henlius has continued to improve and enhance its large-scale production capabilities by establishing three production facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, to form synergy and develop scale effects. The current commercial production capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2026, the total production capacity is expected to reach 144,000 liters, laying a solid foundation for company's medium to long-term global commercial production and business development. In 2023, Henlius’ commercial production facilities and supporting quality management system have undergone/passed intensive on-site inspections and audits conducted by regulatory authorities and international business partners, including the U.S., the EU, PIC/S members Indonesia and Brazil, and Columbia, promoting the global launch of more products, thus benefiting more patients across the world.
Going forward, Henlius will continue to strengthen its innovation capabilities, fully enhance productivity, improve commercialization efficiency, to consolidate positive growth, create diversified growth engines, and pursue a higher-quality development path.
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, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 7 marketing applications have been accepted for review in China, the U.S., 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU 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 HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, 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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