2023年上半年度，复宏汉霖进一步提升自我造血能力，积极打造全方位创新的商业运营模式，不断优化商业化布局，取得了令人瞩目的商业化成绩。公司针对核心肿瘤和免疫治疗产品组建了一支专业、高效的商业化团队，持续推进各产品的商业化进程，多维度提升可及性，并以扎实的专业知识及高效的响应速度为临床提供高品质服务，推动患者获益最大化。两款自营核心产品引领了公司营收的强劲增长，并在欧美主流生物药市场取得重要的里程碑，进一步巩固了复宏汉霖作为国内头部biopharma的领导地位。

汉曲优^®（曲妥珠单抗，欧洲商品名：Zercepac^®，澳大利亚商品名：Tuzucip^®/Trastucip^®）是首款由公司自建商业化团队主导国内市场销售推广的产品，可用于HER2阳性乳腺癌和胃癌的治疗。2023年上半年，汉曲优^®保持了迅猛的增长态势，第一季度即实现国内销售收入约人民币5.386亿元，较去年同期增幅约66.7%。在国内市场，凭借双规格、“即配即用”和不含防腐剂等优势，汉曲优^®广泛应用于临床实践，150mg和60mg双规格均已完成中国境内所有省份的医保准入，截至2023年5月已累计惠及中国患者逾14万名。海外市场方面，作为国产生物药“出海”先锋，汉曲优^®于2020年7月在欧盟获批上市，截至目前已于英国、瑞士、澳大利亚、新加坡、阿根廷、沙特阿拉伯等超过30个国家和地区成功获批上市。2023年上半年，汉曲优^®美国上市许可申请亦获得美国食品药品监督管理局（FDA）受理，有望进一步覆盖欧美主流市场，惠及全球更多患者。

公司首个创新产品H药 汉斯状^®（斯鲁利单抗注射液）于2022年3月正式获批上市，截至2022年末上市9个月销售额达3.391亿元，并于2023年第一季度实现国内销售收入约2.498亿元。2023年3月，该产品首次实现中国境内单月销售额过亿，标志着H药商业化进程迈入发展新阶段。目前H药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）和广泛期小细胞肺癌 (ES-SCLC) ，是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。H药在相关治疗领域具有突破性疗效和差异化优势，展现出了强大的市场竞争力，获得了业内广泛认可，其多项关键性临床研究结果发表于《美国医学会杂志》（JAMA，影响因子：157.3）等国际知名期刊，助力实现市场快速放量。截至2023年6月，H药已完成中国境内27个省份的招标挂网，覆盖全国近千家医院肺癌、消化道肿瘤等科室。公司亦持续丰富多层次医疗保障，成功推动H药进入上海、宁波、厦门、无锡、昆明等多个城市的定制型商业保险目录。2023年3月，H药一线治疗ES-SCLC的欧盟上市许可申请（MAA）获得欧洲药品管理局（EMA）受理，亦计划于2024年在美国递交该产品的上市注册申请（BLA），有望为公司带来了更广阔的发展空间和增长机会。

Henlius Forecasts Profit in 2023 H1: 

Spurring a Seamless R&D, Manufacturing, and Commercialisation Positive Cycle

Shanghai, China, July 3^rd, 2023 – Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited comprehensive management accounts for the six months ended June 30, 2023, the company expects to turn into profits in the first half of 2023, achieving profitability for the first time in a six-month period. The company expects a profit of approximately RMB200 million during the reporting period, primarily contributed by the continuous growth in sales revenue of the company's core products HANQUYOU and HANSIZHUANG, as well as a careful cost control through slimmed down business operations.

Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, remarked: “In the first half of 2023, we have entered a very positive cycle and achieved high-quality development at both the corporate and business levels as a result of our constant desire for self-improvement. Looking ahead, we will continue to prioritize clinical needs, drive cost reduction and efficiency by lean operation, uphold self-development and innovation, and strengthen the synergy between R&D, manufacturing, and commercialisation, and consistently introduce competitive products to contribute to the well-being of patients.”

Accelerating Revenue, Leading Sustainable Growth

In the first half of 2023, Henlius further enhanced its self-sufficiency capabilities and actively advanced new business models. The company continuously optimized its commercialisation layout and achieved remarkable results. With a focus on core oncology and immunotherapy products, Henlius established a professional and efficient commercialisation team, driving the commercialisation process of each product, enhancing accessibility of drugs from multiple dimensions, and providing high-quality services to clinicians with solid expertise and prompt and effective response, thus maximizing the benefits for patients. The revenue growth was led by the outstanding performance of the company's two core products, which also achieved significant milestones in the mainstream biologics markets in Europe and the United States, further cementing Henlius’ reputation as a domestic biopharma leader.

HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®), indicated for the treatment of HER2-positive breast cancer and gastric cancer, is the first product sold and promoted in Chinese mainland by the company’s in-house commercialisation team. In the first quarter of 2023, the domestic sales revenue reached approximately RMB538.6 million, representing a year-on-year increase of approximately 66.7%. In China, HANQUYOU has been widely used in clinical practice due to its advantages such as dual dosage, "ready-to-use" formulation, and preservative-free formulation. To date, both the 150mg and 60mg form of HANQUYOU were included in the medical insurance procurement platform for all provinces in the Chinese mainland, benefiting over 140,000 Chinese patients. In terms of overseas markets, as a pioneer biologic in the "going global", HANQUYOU was approved for commercialisation by the European Commission (EC) in July 2020 and has by far successfully secured marketing approvals in over 30 countries and regions, including the United Kingdom, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia. 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 will further expand the product’s footprint and benefit patients in major markets of biologics in the U.S. and Europe.

The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. By the end of 2022, after 9 months on the market, it achieved sales revenue of RMB339.1 million, and in the first quarter of 2023, the domestic sales revenue reached approximately RMB249.8 million. In March 2023, the product realized a monthly sale of over RMB100 million in Chinese mainland, starting a new stage of its sales growth as well as providing strong momentum for the product’s commercialisation. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). It is also the world's first anti-PD-1 monoclonal antibody (mAb) for the first-line treatment of SCLC. With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and has seen rapid sales uptick. Pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA, Impact Factor: 157.3), contributing to rapid market expansion. As of June 2023, HANSIZHUANG has completed the tendering process in multiple provinces in China, covering nearly a thousand hospitals in relevant departments. The company has also continued to enrich multi-level medical coverage, successfully promoting the inclusion of HANSIZHUANG in customized supplementary medical insurance directories in cities such as Shanghai, Ningbo, Xiamen, Wuxi, and Kunming. In March 2023, the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC, and plans are underway to submit a Biologics License Application (BLA) for it in the U.S. in 2024, presenting broader opportunities and growth prospects for the company.

Cementing Foundations for a More Resilient Future

As a global biopharmaceutical company, Henlius is committed to providing affordable and high-quality biologics to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Incorporating high-efficiency and innovation into its integrated biopharmaceutical platform, the company actively enhances its competitiveness and solidifies the foundation for long-term business development through the entire product life cycle, including R&D, manufacturing and commercialisation. The three production facilities, Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, can altogether reach a larger operational scale with the total commercial production capacity expected to reach 144,000 litres in 2026, further offering a strong support for the company’s global market expansion in the medium to long term.

In terms of R&D, Henlius emphasizes clinical needs and cutting-edge technologies. The company continuously adjust and optimize its research layout and have established innovation centres in Shanghai and California. These two locations synergistically enhance the efficiency and quality of its R&D. Additionally, Henlius actively collaborates with leading academic institutions and global partners worldwide to explore technological innovations and frontier applications. By integrating internal and external resources and professional teams, Henlius is accelerating the development of innovative and differentiated therapies, providing patients with more effective and precise treatment options. Currently, Henlius has pro-actively built a diversified and high-quality product pipeline, including over 50 molecules, and are advancing immuno-oncology combination therapies with proprietary HANSIZHUANG as backbone. Meanwhile, Henlius has conducted over 30 clinical studies for 16 products globally, with independent development accounts for over 80% of the product pipeline.

Moving forward, Henlius will continue to prioritize high-quality development and lean operations, deepen product innovation, expand market presence, and foster global collaborations to offer high-quality, affordable, and innovative medicines to patients worldwide.