复宏汉霖首张年度业绩预喜成绩单，2023年利润预估不低于5亿

2024年3月4日，复宏汉霖（2696.HK）发布正面盈利预告，根据本公司截至2023年12月31日止年度的未经审核综合管理账目及董事会目前可得资料的初步评估，公司预期报告期内将录得年内利润不低于人民币5亿元，这是继首次实现2023半年度盈利之后，公司首次实现全年度盈利。此次盈利主要得益于公司核心产品汉曲优®和汉斯状®的销售收入持续增长以及公司精细化管理下的降本增效。

复宏汉霖董事长兼执行董事张文杰

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2023年对于复宏汉霖具有里程碑意义，我们首次实现了全年盈利，得益于研产销一体化的高效协同和叠加效应，公司在整体决策效率和市场响应方面持续增速，取得了飞跃性的发展。未来，我们将继续精进提质，不断在高质量发展中取得新突破，推动公司走向腾飞新高度！

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复宏汉霖执行董事、首席执行官兼首席财务官朱俊

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复宏汉霖始终以临床需求为精准导向、以创新研发为立足之本，在充满挑战的市场环境下，我们保持战略定力、强化自身差异化优势，在诸多领域不断实现里程碑突破, 推动业绩里程碑式跨越增长。站在发展新起点，我们将继续探索增长新蓝图，并与产业链合作伙伴携手，推动创新药加速造福更多患者。

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高效协同，经营业绩再创新高

2023年，复宏汉霖持续提升自我 “造血” 能力，凭借前瞻性的商业化布局和高效的市场拓展，持续推动产品各项商业化进程，多维度提升产品可及助力患者更长生存获益。公司两款核心产品成为公司营收 “增长极”，国内外市场竞争力持续增强，加码公司高质量发展之路。

汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®/Trastucip®）是中国首个自主研发的中欧双批单抗药物，用于治疗HER2阳性早期乳腺癌、转移性乳腺癌及转移性胃癌。截至目前，汉曲优®已在中国、英国、瑞士、澳大利亚、新加坡、泰国、阿根廷、巴西、沙特阿拉伯等40多个国家和地区获批上市，成为获批上市国家和地区最多的国产生物类似药。凭借150mg和60mg双规格、不含防腐剂等差异化优势，该产品高速拓展中国市场份额，迄今已惠及超过17万名中国患者。2023年上半年，该产品美国上市许可申请获得美国食品药品监督管理局（FDA）受理，有望成为首个在中欧美获批的国产单抗生物类似药，同年7月，其在加拿大的上市注册申请也获得了加拿大卫生部受理，将进一步覆盖欧美主流生物药市场。

公司首个创新型单抗H药 汉斯状®（斯鲁利单抗）于2022年3月获批上市，目前已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC），并且是全球首个一线治疗小细胞肺癌的抗PD-1单抗。2023年12月，H药第5个适应症一线治疗非鳞状非小细胞肺癌（nsNSCLC）上市注册申请获中国国家药监局（NMPA）受理，有望于2024年下半年获批。上市以来，H药以突破性疗效和差异化优势，获得业内广泛认可，市场竞争力和影响力不断提升。截至目前，该产品已完成中国境内所有省份的招标挂网并成功纳入逾70个省/城市级惠民保，惠及患者超过5.5万人。此外，复宏汉霖携手全球知名制药企业，持续拓展H药海外版图，对外授权已覆盖美国、欧洲、东南亚、中东和北非、印度等国家和地区。2023年12月，该产品于印度尼西亚获批上市，成为首个在东南亚国家成功获批上市的国产抗PD-1单抗。在欧美生物药市场，H药针对ES-SCLC的上市申请也已在欧盟获受理，此外，复宏汉霖还在美国启动了一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验，以进一步支持其在美国的申报上市，推动 “中国制造” 走向更广阔的舞台。

多维发力，加快满足临床之需

创新是复宏汉霖可持续发展的基石。我们始终坚持“以患者为中心”，持续深化和贯彻差异化的创新战略，搭建多元化和高品质的产品管线，并加速成果转化落地。目前，公司产品管线已涵盖约60个分子，覆盖单抗、多抗、抗体偶联药物（ADC）、融合蛋白、小分子药物等药物形式，其中超过80%的产品为自主开发。2023年，公司在全球范围内加速推进H药、HLX11（帕妥珠单抗生物类似药）、HLX14（地舒单抗生物类似药）和HLX04-O（抗VEGF单抗）等多个已上市或临床后期阶段产品的国际多中心III期临床研究，并完成美国、欧盟等国家和地区的首例受试者给药。此外，公司积极探索新靶点、新机制，不断拓展产品疾病领域和新分子类型，全力推进HLX42（EGFR ADC）及HLX43（PD-L1 ADC）等多款潜在first/best-in-class产品进入I期临床研究阶段，并成功获得多款产品的突破性疗法认定和快速通道资格认定，创新产品布局进一步加速。

作为一家国际化的生物制药企业，复宏汉霖持续完善和提升大规模生产能力，陆续建立徐汇、松江（一）、松江（二）三大生产基地，形成协同和规模效应，目前商业化总产能已达48,000升，实现中国、欧洲、东南亚和部分拉美市场的常态化供应，2026年有望达到144,000升，为公司中长期全球商业化生产及业务发展构筑坚实基础。2023年，公司生产基地及质量管理体系密集接受或通过美国、欧盟、药品检查合作计划（PIC/S）成员巴西及印度尼西亚、哥伦比亚等各国药监机构以及国际合作伙伴实施的实地核查或审计，推动公司产品扩容“全球版图”、造福全球更多患者。

未来，复宏汉霖将继续加强创新策源能力、全力推进产能建设、提升产品商业化效率，夯实企业正向循环基本盘，打造多元增长引擎，向着更高的发展目标铿锵迈进。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在国际上市2款产品，19项适应症获批，7个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地和松江基地（一）均已获得中国和欧盟GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药 汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

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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