2024年8月26日，复宏汉霖（2696.HK）发布2024年度中期业绩，于业绩期内实现营业收入约人民币27.461亿元，较去年同期增长约9.8%，净利润约人民币3.863亿元，较去年同期增长约61.0%，多款核心商业化产品赋能业绩持续增长，实现产品销售收入24.794亿元，保持高质量盈利。汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）和H药 汉斯状®分别实现销售收入约14.743亿元及6.778亿元。同时，公司加速拓展全球商业化版图，挖掘海外市场增长潜力，为长期高质量发展注入澎湃动能。
截至目前，复宏汉霖已有6款产品在中国上市，3款产品在全球获批上市，24项适应症获批，触达48个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，并惠及逾60万名患者。业绩期内，公司完成近80项药政注册申请，并收获60余项药政注册批准，覆盖中国、美国、欧盟、加拿大、印尼和日本等国家和地区，加速产品全球化进程。同时，公司秉持差异化的创新策略，持续丰富并优化产品管线，布局50余个分子和14个研发平台，药物形式覆盖单抗、多抗、抗体偶联药物、融合蛋白、小分子药物等。
复宏汉霖董事长、执行董事张文杰表示：
2024上半年，复宏汉霖完善的商业化布局和策略效益凸显，继2023年首次年度盈利后，公司实现了持续盈利和稳健增长，开启了崭新的发展篇章。展望未来，复宏汉霖将进一步激发创新动能，以更加积极的姿态应对外界变化。同时，持续深化精益管理和运营体系，着力加固企业发展护城河，向成为高质量发展的国际化创新生物制药企业的目标继续迈进。
复宏汉霖执行董事、首席执行官朱俊表示：
创新和国际化是引领我们持续前行，不断解决未满足的临床需求的两大核心策略。2024上半年，复宏汉霖全球商业化版图再度刷新，出海之路硕果累累，我们的创新蓄水池加速扩增，差异化创新优势进一步夯实。未来，我们将继续坚持‘以患者为中心’的理念，专注于开发具有临床价值的突破性治疗方案，加速惠及全球更多患者。
全球化布局：
出海高歌猛进，商业化空间广阔
2024年上半年，复宏汉霖继续高效推动研产销一体化发展，并不断完善管理体系提升商业化运营效率，通过多维提升产品可及性、探索业态多元化等举措，促进核心产品的商业化增长实现持续高质量盈利。与此同时，公司在全球市场的扩展上取得重要新突破，多个新市场的获批准入和实现销售为公司海外市场增长带来新活力。业绩期内，公司5款产品销售收入合计约人民币24.794亿元，同比增长15.2%。其中，汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、H药 汉斯状®（斯鲁利单抗）和汉贝泰®（贝伐珠单抗）于2024上半年分别实现销售收入人民币14.743、6.778、0.867亿元。此外，基于与合作伙伴的约定，公司就汉利康®（利妥昔单抗）、汉达远®（阿达木单抗）分别实现销售收入约人民币2.270亿元和0.136亿元。
公司核心抗肿瘤产品汉曲优®持续保持良好增长势头，2024年上半年达成全球销售收入约人民币14.743亿元，同比增长15.5%。截至目前，该产品已在全球48个国家和地区获批，覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，为获批上市国家和地区最多的国产单抗生物类似药，累计惠及超过200,000名患者。其中，汉曲优®国内市场份额不断攀升，2024上半年实现销售额约人民币14.062亿元，较去年同期增长约13.5%。凭借差异化的临床用药优势和历经验证的国际品质，汉曲优®逐步获得医生、患者及行业等多方认可，成为国内曲妥珠单抗的领导品牌。同时，汉曲优®在海外市场高歌猛进，于业绩期内实现销售收入约0.682亿元，同比增长79.1%。2024年4月，汉曲优®在美国获批上市，成为中美欧三地获批的国产单抗生物类似药；并于2024年6月成功发货沙特，有望成为首个登陆中东市场的国产单抗生物药。此外，截至2024年8月，汉曲优®还新增加拿大、菲律宾、巴西、乌兹别克斯坦、土库曼斯坦等市场获批上市，推动更多患者获益。
H药 汉斯状®是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、印尼、柬埔寨、泰国等地获批上市。2024年上半年，汉斯状®实现销售收入约6.778亿元，同比增长21.8%。目前，H药已有4项适应症获批，广泛覆盖肺癌、消化道肿瘤等高发肿瘤，累计惠及逾7.5万名患者。该产品第5项适应症一线治疗非鳞状非小细胞肺癌（nsNSCLC）的上市注册申请也已获中国国家药监局（NMPA）受理，有望在今年下半年获批。2024年上半年，H药在海外市场实现销售及授权许可收入约0.752亿元。截至目前，H药对外授权已覆盖美国、欧洲、东南亚、中东和北非、印度等70多个国家和地区，并成为首个登陆东南亚国家的国产抗PD-1单抗。2024年第一季度，公司高效完成H药的首批海外发货，开启了该产品惠及全球患者的新篇章。此外，H药一线治疗ES-SCLC的欧盟上市许可申请（MAA）已获得欧洲药品管理局 (EMA) 受理，有望于2024年获批上市。公司亦于新加坡、马来西亚等国家递交了H药上市许可申请。同时，公司还稳步推进H药对比一线标准治疗阿替利珠单抗用于治疗ES-SCLC的头对头美国桥接试验，并计划于2025年初递交H药在美国的生物制品许可申请（BLA）。
2024年上半年，复宏汉霖商业合作再迎多个里程碑。公司与Sermonix就临床阶段在研新型乳腺癌内分泌疗法HLX78（拉索昔芬）达成亚洲区域合作。同时，公司与甫康药业就汉奈佳®（奈拉替尼）达成商业化合作，进一步丰富公司乳腺癌治疗产品管线，该产品能够与汉曲优®实现序贯治疗，有望进一步降低HER2阳性早期乳腺癌患者复发风险。公司亦携手Accord、Eurofarma、KGbio、Organon等国际合作伙伴加速推进更多产品在全球的上市注册进程。业绩期内，汉利康®于秘鲁获批，成为公司第三款海外获批上市的自主研发和生产的产品。与此同时，HLX14（地舒单抗生物类似药）在欧盟的上市申请已于2024年5月获得受理，有望于2025年获得上市批准。公司亦计划于2024下半年分别递交HLX14在美国的上市许可申请，及HLX11（帕妥珠单抗生物类似药）在中国和美国的上市许可申请。
协同化发展：
加速扩增创新蓄水池，国际品质护航生产
2024上半年，秉持可负担的创新这一初心，复宏汉霖持续完善和拓展差异化的创新管线，积极布局更广泛的疾病领域和新分子类型。聚焦临床需求，公司积极推进H药、HLX22（抗HER2单抗）、HLX42（EGFR靶向ADC）、HLX6018（抗GARP/TGF-β1单抗）等创新产品的临床开发进程。业绩期内，H药联合贝伐珠单抗及化疗一线治疗结直肠癌的国际多中心III期临床研究获日本药品医疗器械综合机构（PMDA）许可，并完成全球首例患者给药。引领HER2双靶向疗法，HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临床研究申请获得美国食药监局（FDA）许可。同时，H药、HLX22等创新产品的多项研究结果亦登上AACR、ASCO、ASCO GI、ESMO GI、ENCALS等国际学术会议和Cancer Cell、Med等国际知名期刊。2024上半年，公司潜在FIC/BIC 的创新型EGFR靶向ADC HLX42、慢性炎症性疾病领域首款创新产品HLX6018成功完成首例受试者给药。双免疫联合抗血管靶向疗法--HLX53（抗TIGIT Fc融合蛋白）联合H药及贝伐珠单抗亦获NMPA批准并完成II期临床试验的首例患者给药，拟用于局部晚期或转移性肝细胞癌的一线治疗。
在加码创新的同时，国际领先的高品质生产能力助力公司实现全球商业化布局，为将研发成果转化为普惠患者的社会价值提供重要保障。公司现有上海徐汇、松江（一）和松江（二）三大生产基地，松江基地（二）一期项目第一、二阶段两幢主要生产楼已完成包括原液、制剂生产线和首条预灌封系统（PFS）的设备安装调试及部分设备验证工作，一期项目第三阶段已完成主体结构封顶。目前公司商业化总产能达48,000升，已实现中国、欧洲、东南亚、拉美及中东等市场的稳定商业化供应。公司始终以国际化品质践行“汉霖质量”，其商业化生产基地及配套的质量管理体系已通过约百项由中国国家药监局、欧洲药品管理局（EMA）、美国食药监局（FDA）、欧盟质量受权人（QP）以及公司国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟和美国GMP认证。公司积极推行精益项目运营，迭代升级生产工艺，以数字化建设赋能供应链、库存及质量管理，提质增效，把“可负担的创新，值得信赖的品质”落到实处。
未来，聚焦患者未满足的临床需求，复宏汉霖将进一步夯实biopharma的商业化能力，不断提升研产销一体化平台的开发及运营效率，继续在创新与国际化的道路上加速疾驰，让更多、更高质量的创新成果惠及全球患者。
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，已有6款产品在中国获批上市，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟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，公司商业化生产基地已相继获得中国、欧盟和美国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50多个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，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 Maintains Patient-Centric Focus, Drives Sustainable Growth, and Accelerates Overseas Expansion in 2024 H1
Shanghai, China, August 26, 2024 – Henlius (2696.HK) announced its 2024 interim results. During the reporting period, Henlius’ revenue reached about RMB2.7461 billion, representing an increase of 9.8% YoY, and recorded a net profit of RMB386.3 million, up by 61.0% YoY. The solid and sustained profitability is due to increasing commercial sales of the company’s core products, which reached approximately RMB2.4794 billion. HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) and HANSIZHUANG recorded sales of RMB1.4743 billion and RMB677.8 million, respectively. Meanwhile, the company accelerates the expansion of its global commercial footprint, unleashing the potential of overseas markets to promote its long-term high-quality development.
Up to date, Henlius has 6 products launched in China, 3 approved for marketing in overseas markets, 24 indications approved worldwide, benefiting over 600,000 patients and reaching 48 markets in Asia, Europe, Latin America, North America and Oceania. During the reporting period,
the company submitted approximately 80 drug registrations, and received more than 60 approvals in China, the U.S., EU, Canada,
Indonesia and Japan. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. Currently, its product pipeline covers more than 50 molecules and 14 R&D platforms with the forms of drug covering mAb, pAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, etc.
Wenjie Zhang, Chairman and Executive Director of Henlius, said:" In the first half of 2024, we have received impressive results based on our well-established commercial strategy and layout. Following the first time full-year profits in 2023, we achieved sustainable profitability and steady growth, opening a new chapter of high-quality development. Looking forward, we will further promote differentiated innovation and proactively respond to external changes. Meanwhile, we will continue to advance lean management and operations to solidify our leading position, progressing towards an innovative global biopharmaceutical company with a focus on high-quality development."
Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said:" Innovation and globalisation are two core strategies propelling us along the journey of addressing unmet clinical needs. In the first half of 2024, we have been actively expanding our global footprint with significant milestones achieved on our way of going abroad. Meanwhile, our innovation landscape has rapidly expanded, further strengthening our differentiated innovations. In the future, we will adhere to patient-centricity and stay committed to providing high-quality and innovative therapies to benefit more patients worldwide."
Global Expansion: Swift Overseas Commercialisation & Vast Market Opportunities
In the first half of 2024, Henlius
continued to efficiently drive the integrated development of research,
production, and commercialisation, while constantly improving commercial
operational efficiency. Through multi-faceted measures such as improving product
accessibility and exploring diversified business models, the company fostered
the commercial growth of its core products, achieving sustained high-quality
profitability. Furthermore, the company has achieved notable milestones in its
global market expansion endeavors, with approvals and successful
commercialisation across various markets infusing fresh momentum into the
growth of its overseas presence. During the period, Henlius’ five products reached total sales revenue of approximately RMB2.4794 billion, up by 15.2% YoY. HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB1.4743 billion, RMB677.8 million and RMB86.7 million, respectively. In addition, the company received sales revenues of RMB227.0 million and RMB13.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.
Henlius' core oncology product HANQUYOU maintains a positive growth momentum. During the reporting period, HANQUYOU has recorded a global sales revenue of RMB1.4743 billion, up by 15.5% YoY. To date, HANQUYOU has been approved in 48 countries and regions around the world, covering Asia, Europe, Latin America, North America, and Oceania, making it the China-developed monoclonal antibody (mAb) biosimilar with the most marketing approvals, benefiting more than 200,000 patients. From which, HANQUYOU recorded domestic sales of RMB1.4062 billion, representing growth of 13.5%, further expanded its market share in China. Due to its differentiated clinical advantages and international recognised quality, HANQUYOU has been widely used in clinical practice and achieved rapid market acceptance, making it the leading brand of trastuzumab in China. Moreover, Henlius has proactively pursued overseas commercialisation of HANQUYOU, overseas revenue from product sales recorded RMB68.2 million approximately, up by 79.1% YoY. In April 2024, it received marketing approval from the U.S. Food and Drug Administration (FDA), making it a China-developed mAb biosimilar approved in China, the EU, and the U.S. In June 2024, HANQUYOU made its first delivery to Saudi Arabia，poised to be the first Chinese mAb to enter the Middle Eastern market. As of August 2024, the overseas commercialisation of HANQUYOU managed to include the markets of the U.S., Canada, the Philippines, Brazil, Uzbekistan and Turkmenistan, bringing more benefits to patients.
HANSIZHUANG is the world’s first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China, Indonesia, Cambodia and Thailand. During the reporting period, HANSIZHUANG has recorded a sales revenue of RMB677.8 million, representing an increase of 21.8% YoY. Up to now, it has been approved for 4 indications, broadly covering high-incidence tumours including lung cancer and gastrointestinal cancer, benefiting over 7,5000 patients. Additionally, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA), and expected to be approved in the second half of 2024. On the other hand, overseas sales revenue and licensing of HANSIZHUANG recorded RMB75.2 million approximately. Henlius continues to expand HANSIZHUANG’s global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA, making it the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. In the first quarter of 2024, Henlius has finished the first international shipment of HANSIZHUANG, opening a new chapter in benefiting patients worldwide with this product. HANSIZHUANG’s Marketing Authorisation Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA), which is expected to be approved in 2024. The company has also submitted marketing applications for HANSIZHUANG in Singapore and Malaysia to further promote the product in Southeast Asia. Moreover, Henlius steadily advances 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, and plans to submit the Biologic License Application (BLA) of the product in the U.S. in early 2025.
In the first half of 2024, Henlius achieved a number of milestones in business development. Regarding HLX78 (lasofoxifene), the company expanded its collaboration with Sermonix in all of Asia. Additionally, Henlius reached cooperation with Convalife to commercialise neratinib (trade name: HANNAIJIA), which is indicated for extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy, further enriching the company’s product pipeline for breast cancer treatment and creating synergy with HANQUYOU. Meanwhile, the company joined hands with international partners such as Accord, Eurofarma, KGbio and Organon to accelerate overseas commercialisation of its products. In the first half of 2024, HANLIKANG, the first biosimilar launched in China, has been approved to be marketed in Peru, which made it the company’s third self-developed and manufactured product breaking into global markets. Furthermore, the marketing application for HLX14 (denosumab biosimilar) has been accepted for review in European Union (EU) in May 2024, and expected to be approved in 2025. The company also plans to submit marketing applications for HLX14 in the U.S., and for HLX11 (pertuzumab biosimilar) in China and the U.S. in the second half of 2024.
Synergistic Growth: Accelerating Innovation & Ensuring Manufacturing Meets International Quality Standards
In the first half of 2024, Henlius hase been continuously advancing its differentiated R&D pipeline with the vision of offering high-quality and affordable innovation products, proactively exploring novel modalities and diverse disease areas. Guided by unmet clinical needs, the company has accelerated the clinical researches of a number of innovative products including HANSIZHUANG (serplulimab), HLX22 (anti-HER2 mAb), HLX42 (EGFR-targeting ADC) and HLX6018 (anti- GARP/TGF-β1 mAb). During the reporting period, the phase 3 international multicenter clinical study (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy indicated for the treatment of metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and completed dosing of the first subject in China. Meanwhile, a phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the treatment of HER2-positive advanced gastric cancer has been approved by the U.S. FDA. The latest results for innovative products such as HANSIZHUANG and HLX22 have been presented to global academic community, including Cancer Cell, Med, AACR, ASCO, ASCO GI, ESMO GI, and ENCALS, gaining wide recognition. Moreover, the company has completed the first patient dosing for clinical trials of HLX42, the potential first/best-in-class EGFR-targeting ADC, and of HLX6018, the company’s first novel product in chronic inflammatory diseases area. In addition, the company has received the IND approval for the clinical trial of novel anti-TIGIT fc fusion protein HLX53 in combination with HANSIZHUANG plus HANBEITAI for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC) from the NMPA, and has completed the first patient dosing for a phase 2 clinical trial.
While boosting innovation, Henlius is steadily consolidating international high quality manufacturing capability to accelerate its global commercialisation layout, translating the R&D efforts into social impact and commercial results. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. Regarding Songjiang Second Plant, the company has completed construction and validation of drug substance (DS), drug product (DP) and prefilled syringes system (PFS) line of the two major manufacturing buildings in the Phase I & II project, and main structural framework was topped out in the Phase III project. Currently, the commercial capacity of the company is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia, Latin America and Middle East. Additionally, the company has always been upholding the highest quality standards, allowing its products to go global. As of now, Henlius’ commercial production facilities and supporting quality management system have also passed nearly one hundred on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person (QP), as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies. The company also adopted a series of lean operation projects, optimised production processes, utilized digital technology to empower supply chain, inventory and quality management, putting "affordable innovation, trustworthy quality" into practice.
Focusing on patients unmet clinical needs, Henlius will further strengthen its commercialisation capabilities as a biopharma, improve the operation efficiency of its integrated biopharmaceutical platform, and expand its global presence, enabling high-quality innovative outcomes to benefit more patients worldwide.
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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 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), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), 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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