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1款产品，13项适应症获批，4个上市注册申请获得中国药监局受理。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，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国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，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就13个产品、11个免疫联合治疗方案在全球范围内开展20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 2022 H1 Results: Sharpen all-round edges, advance in evolution to BiopharmaShanghai, China, August 18th, 2022—Henlius (2696.HK) announced its 2022 interim results. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 5 products launched in China, 1 in global, 13 indications approved and 4 New Drug Applications (NDAs) now accepted by the National Medical Products Administration (NMPA), focusing on oncology, autoimmune diseases, ophthalmic diseases, etc. In the first half of 2022, Henlius revenue reached approximately RMB1.289 billion, representing an increase of 103.5% YoY, which mainly benefited from the sales revenue and licensing revenue brought by the successive commercialisation of various products. While promoting the commercialisation of products at full speed, Henlius continued increasing innovation and research and development. In the first half of 2022, the company’s R&D expenditure reached approximately RMB827.4 million.Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, remarked: “In the first half of 2022, we worked as one to navigate the challenges of the pandemic, spared no effort to ensure operation, went all out to meet patient needs, and delivered robust growth in performance. It was a key six months for Henlius to evolve from biotech to biopharma. We launched the first innovative product HANSIZHUANG. We joined hands with Organon to achieve a breakthrough in out-licensing. We doubled commercial capacity to 48,000L. We presented ES-SCLC data of HANSIZHUANG in oral on ASCO. Going forward, we will continue to focus on clinical needs to bring more products to patients worldwide.”Accelerated sales growth in the Chinese market, comprehensive layout of the global commercialisation networkHenlius has launched 5 products in China, which have been widely recognized for their excellent quality, safety and clinical efficiency, and have established a certain brand presence in the field. The company has established a professional and efficient commercialisation team with more than 800 professionals for core products in tumour and immunotherapy and steadily advances the commercialisation of various products, actively improves accessibility, and provides high-quality clinical services with solid professional knowledge and efficient response speed to maximize the benefits of patients.In the first half of 2022, Henlius’ core anti-tumour product, HANQUYOU (trastuzumab, Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has recorded a steady growth in sales across China and Europe market, with domestic sales revenue reaching approximately RMB800.2 million, an increase of 178.2% YoY. Overseas sales revenue recorded RMB12.5 million approximately, while revenues from overseas licensing recorded RMB2.4 million, both are based on the collaboration with Accord. Up to now, HANQUYOU has been launched in more than 30 countries including China, the United Kingdom (UK), France, Germany, Switzerland, and Australia. It is the first product commercialized by the company’s in-house commercial team in the Chinese market. With 150mg/60mg dual specifications, no preservatives and other differentiated advantages, HANQUYOU meets the flexible clinical needs of medication, and can be used immediately without residual liquid storage. It has been widely recognized by clinicians, patients and the industry. So far, the product has benefited more than 70,000 patients in China.HANSIZHUANG (serplulimab) is Henlius’ first self-developed innovative monoclonal antibody and the fifth product launched into the market. In March 2022, HANSIZHUANG was approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours. By the end of June 2022, HANSIZHUANG sales revenue recorded RMB76.9 million. Meanwhile, the NDAs of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC and for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) have been accepted by the NMPA. The phase 3 clinical study of HANSIZHUANG in combination with chemotherapy as a first-line treatment for patients with locally advanced/metastatic esophageal squamous cell carcinoma also met the co-primary endpoints. The company plans to submit the NDA for this indication in the second half of 2022.HANLIKANG (rituximab) is the first biosimilar in China. It is also the rituximab with the most approved indications in China. It has benefited more than 130,000 Chinese patients since its launch to the market. The domestic commercial sales of HANLIKANG is being handled by Jiangsu Fosun. In the first half of 2022, HANLIKANG received a profit-sharing of RMB272.1 million from the partner and licensing revenue of RMB9.3 million. In February 2022, HANLIKANG has been approved for the new indication for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis. By providing low-frequency dosing and long-lasting efficacy, it can improve the quality of life for a wide range of patients.In the first half of 2022, Henlius has closed over multiple out-licensing deals for Henlius’ four biosimilars on the market and other products in development. Through commercial collaborations with overseas pharmaceutical companies, the company aimed to further promote the entry of self-developed products into the global market. In the first half of 2022, Henlius has collaborated with Getz Pharma, Eurofarma and Abbott to bring HANDAYUAN, HANLIKANG, HANQUYOU and HANBEITAI to 27 emerging market countries in Asia, Africa, Europe and Latin America such as Pakistan, Nigeria and Brazil respectively. In June 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialisation of Henlius’ independently developed HLX11 (pertuzumab biosimilar) and HLX14 (denosumab biosimilar) in ex-China countries, covering mature markets such as the United States (US), the European Union (EU) and Japan, as well as a number of emerging markets. Under the agreement terms, Henlius may receive up to a total of USD541 million including a USD73 million upfront payment.“Self-developed products + license in”, steady progress in innovative R&D layoutsThe first half of 2022 saw Henlius continue its innovation and R&D initiatives, reaching 10 important milestones in clinical trials, approving 5 products and 2 combination therapies. Up to now, Henlius has accumulatively obtained more than 70 clinical trial approvals worldwide, and conducted over 20 clinical trials in China, the EU, Australia and other countries and regions.Henlius has actively expanded its differentiated advantages for HANSIZHUANG and has launched 11 clinical trials of combination therapy worldwide, covering a wide range of high-incidence and large tumour types such as lung cancer, esophageal cancer, head and neck cancer, and gastric cancer, with over 3,100 patients enrolled globally. The company has comprehensively deployed the first-line treatment of lung cancer, carried out a phase 3 multi-centre clinical trial, also known as ASTRUM-005, for the indication of ES-SCLC in research centres in China, Turkey, Poland, Georgia and other countries, and enrolled more than 30% of the Caucasian population. The clinical trial data of ASTRUM-005 were first presented as an oral presentation at the 2022 ASCO Annual Meeting of the American Society of Clinical Oncology. In April 2022, the US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG for the treatment of small cell lung cancer (SCLC). Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA’s Class C consultation meeting, Henlius is planning to soon carry out a bridging study in the US and expected to submit BLA to FDA by the end of 2023. At present, there is no anti-PD-1 monoclonal antibody approved for the first-line treatment of SCLC in the world. HANSIZHUANG is expected to become the world’s first anti-PD-1 monoclonal antibody for the first-line treatment of SCLC and to fill the clinical gap in the first-line treatment of SCLC with PD-1 inhibitors in the next five years.As of the first half of 2022, HLX11 (pertuzumab biosimilar) and HLX14 (denosumab biosimilar) developed by Henlius independently has successfully completed the first subject dosing in its phase 3 clinical studies. Recently, HLX14 received clinical trial approval in Australia for the phase 3 multicentre clinical study. Moreover, first patient in Australia and the EU country Latvia was dosed in a global multicentre phase 3 clinical trial of HLX04-O, a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the company and Essex. It has also received approval for conducting clinical trials in several countries and regions, including China, the US, the EU and Singapore. In the first half of 2022, HLX208 (BRAF V600E inhibitor) and HLX07 (anti-EGFR mAb) have entered into the phase 2 clinical trial which has the potential to create synergies with multiple products in the company’s own pipeline.In addition, the company continues to make every effort to promote LAG-3, TIGIT, 4-1BB, GARP and other innovative target products into the clinical research stage. The potential first-in-class HLX301 (anti-PD-L1×TIGIT BsAb) and HLX35 (anti-EGFR×4-1BB BsAb) has dosed the first subject in its phase 1 clinical studies in Australia and China, respectively. The investigational new drug applications (IND) of HLX53 (anti-TIGIT Fc fusion protein) and HLX26 (anti-LAG-3 mAb), both developed independently by Henlius, have been approved by the NMPA for the treatment of advanced/metastatic solid tumours or lymphomas.Synergising the Innovation centres in China and the US, the company continues to strengthen translational medicine capabilities, with antibody technology as the core, combined with novel coupling techniques to vigorously construct various forms of antibody conjugated platform and promote differentiated innovation, and strive to meet unmet clinical needs. Henlius has also expanded its pipeline of innovative potential targets through in-licensing and partnerships. In the first half of 2022, the company has entered a strategic collaboration with Palleon Pharmaceuticals to develop and commercialize two bifunctional sialidase programs which will further enhance the company’s competitiveness in the global oncology field.Double the production capacity to boost market expansion with an integrated production platformHenlius has been building an integrated and comprehensive production platform to further consolidate the company’s entire industrial chain layout. The current total commercial production capacity has reached 48,000 liters, and the total production capacity in 2026 is expected to reach 144,000 liters. In the first half of 2022, the company continued scaling up production capacity. Songjiang First Plant was approved for the commercial production of HANQUYOU and has been officially put into operation, which effectively ensures market penetration and forms synergy with the Xuhui Facility with a commercial production capacity of 24,000 liters. The company’s commercial production facility and supporting quality management system have been certificated by China and the EU GMP. They have also passed on-site inspections and audits conducted by the NMPA, European Medicines Agency, the EU Qualified Person, and international business partners. The 5 launched products are now available for commercial production, and can be stably supplied in the Chinese and the EU markets.In order to meet the global commercial production needs, the company is constructing the Songjiang Second Plant, with a total capacity of 96,000 liters in the first phase. The designed production capacity for the first and second stages of the first phase is a total of 36,000 liters, and the first engineering run of the Songjiang Second Plant project is expected to be completed by the end of 2022. The designed production capacity of the third stage of the first phase is 60,000 liters. The piling work has been completed. The main structure is expected to be topped out in 2023. In the future, the company will continue delivering products with “Henlius Quality” based on international standards, ramping up capacity progress in a bid to build competitiveness with economics of scale, and driving cost reduction and efficiency by lean operation, thus spurring the evolution to Biopharma.Henlius has always been patient-centred, continuously promoting the construction of the entire industry chain platform, enhancing the ability to integrate research, production and sales, and accelerating the company’s evolution to Biopharma. In the future, the company will continue to deepen global innovation, expand production capacity, empower the commercialisation process, and bring more and better treatment options to patients around the world.
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, 1 in global, 13 indications approved worldwide, and 4 New Drug Applications (NDAs) accepted for review in China. 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 Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China 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, 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 and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies, expanding its presence in major markets as well as emerging markets.
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