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2023-11-15

复宏汉霖2023前三季度总收入超39亿,盈利能力持续提升


2023年11月15日,复宏汉霖(2696.HK)发布2023年前三季度业绩,截至2023年9月30日,公司实现营业收入约人民币39.278亿元,较去年同期增长约84.0%,2023年前三季度盈利达4.078亿元,主要源自公司卓越商业化的持续加码和高效落地。汉曲优®(曲妥珠单抗,欧洲商品名:Zercepac®,澳大利亚商品名:Tuzucip®和Trastucip®)及H药 汉斯状®(斯鲁利单抗)于2023年前三季度分别实现了人民币20.145亿元及8.654亿元的销售收入。


作为一家国际化的创新生物制药公司,复宏汉霖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。截至目前,复宏汉霖已有5款自研产品上市,惠及逾49.5万名患者,触达全球超过40个市场。同时,公司现有10余个上市注册申请获欧盟、美国、加拿大、巴西、哥伦比亚、印度尼西亚、新加坡等多个国家和地区药品监管部门受理。


复宏汉霖董事长兼执行董事 张文杰

2023年前三季度,复宏汉霖交出了一份亮眼的成绩单,继首次实现半年度盈利后,我们一体化的生物制药平台能力持续得以验证,卓越的商业化成绩彰显,增长潜能逐步释放。在产品价值最大化,造血能力更加稳固的同时,我们强化内功修炼,精细化运营管理,不断夯实高质量发展的根基和优势,共同打造一个更高价值的国际化生物制药企业。

复宏汉霖执行董事、首席执行官

首席财务官 朱俊

2023年以来,我们坚持以创新和国际化战略为驱动,瞄准全球更多未满足的临床需求,在创新的赛道上疾速奔驰,在国际市场上取得长足发展。未来,复宏汉霖也将以终为始,持续夯实核心竞争力,让优质可及的生物药早日惠及全球更多患者。


商业化势头高涨  海外拓展步履铿锵

2023年第三季度,复宏汉霖延续了高昂的增长势头,多款商业化产品显著提速放量,在全球范围内取得里程碑进展,实现产品销售收入合计人民币12.256亿元。其中,公司核心肿瘤产品汉曲优®、汉斯状®汉贝泰®(贝伐珠单抗)分别实现销售收入约7.378亿元,3.091亿元和0.364亿元。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)分别获得销售利润分成约人民币1.310亿元和0.113亿元。



汉曲优®作为国内唯一具有150/60mg双规格、不含防腐剂的曲妥珠单抗,凭借差异化优势,进一步扩大其中国市场份额,自上市以来已惠及中国患者约15.5万人。2023年7月,继美国食品药品监督管理局(FDA)受理上市许可申请(BLA)之后,汉曲优®的上市注册申请进一步获得加拿大卫生部受理。截止目前,汉曲优®已在中国、英国、瑞士、澳大利亚、新加坡、阿根廷、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。


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。自2022年3月获批上市以来,H药凭借突破性疗效和差异化优势,展现出强大的市场竞争力,获得了业内广泛认可,截至目前已惠及中国患者约4.3万人。继获批微卫星高度不稳定(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)适应症,H药于2023年9月成功斩获第四项适应症食管鳞状细胞癌(ESCC),标志着复宏汉霖在消化道肿瘤领域的布局再下一城,全面进入商业化放量“加速期”。此外,复宏汉霖亦计划于2023年第四季度就H药一线治疗非鳞状非小细胞肺癌(nsNSCLC)在中国递交上市注册申请。


2023年,复宏汉霖海外拓展成效显著,国际化开辟增长新空间。基于合作约定,公司于2023年前三季度获得授权许可及研发服务收入约人民币5.467亿元,同比增长232.1%。报告期内,公司进一步协同合作伙伴拓展H药的全球商业化蓝图。2023年9月,公司再度携手H药在东盟十国的合作伙伴KGbio,就H药在中东北非地区12个国家的独家开发和商业化权益达成合作。2023年10月,公司扩大与Intas的合作,授权其H药在欧洲和印度的独家开发和商业化权益,潜在总收入预计可达1.85亿欧元。


创新稳步进阶 竞速全球高质量发展

2023年,复宏汉霖持续贯彻创新策略,拓展全球研发布局,“内外兼修”加速推动更多创新成果的转化和落地。目前,公司已前瞻性布局了一个多元化、高质量的产品管线,涵盖60多个分子,覆盖单抗、双抗、抗体偶联药物(ADC)、重组蛋白、小分子偶联药物等药物形式,其中超过80%的产品均为自主开发。




公司全面推进基于H药汉斯状®的肿瘤免疫联合疗法,在全球同步开展10余项免疫联合疗法临床试验,累计全球入组患者超3,600人。在肺癌领域,H药联合化疗一线治疗nsNSCLC的3期临床研究已经达到主要研究终点;H药联合化疗同步放疗治疗局限期小细胞肺癌(LS-SCLC)的国际多中心3期临床研究、联合HLX26(抗LAG-3单抗)和化疗一线治疗晚期NSCLC的2期临床研究分别完成欧盟、中国境内的首例患者给药。同时,公司已于2023年7月成功完成HLX04-O(抗VEGF单抗)治疗湿性年龄相关性黄斑变性(wAMD)的1/2期临床试验。


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,全力推进多款潜在first/best-in-class产品进入临床研究阶段。潜在同类最佳的EGFR ADC新药HLX42及潜在同类首个PD-L1 ADC新药HLX43已于2023年10月同步获得中国国家药监局(NMPA)临床试验批准,其临床前研究数据于2023 ESMO上首发亮相。


2023年,复宏汉霖持续完善和提升基于健全质量管理体系的大规模生产能力,为不断提升产品全球可及性奠定坚实基础。公司现有商业化总产能48,000升,已实现中国、欧洲和部分拉美市场的常态化供应,2026年总产能预计可达144,000升。同时,复宏汉霖始终以国际化品质践行“汉霖质量”,公司生产基地及质量管理体系已通过近百项由各国药监机构以及国际合作伙伴实施的实地核查或审计,其中徐汇基地已获中国和欧盟GMP认证,松江基地(一)已获中国GMP和欧盟质量受权人(QP)认证。2023年7月,公司松江基地(一)接受了美国FDA对汉曲优®的上市许可前检查;8月,徐汇基地、松江基地(一)部分区域接受了荷兰卫生监督机构Health and Youth Care Inspectorate针对汉斯状®的欧盟上市前GMP现场检查。2023年10月,公司徐汇基地先后通过了药品检查合作计划(PIC/S)成员印尼食品药品监督管理局(BPOM)针对H药汉斯状®和巴西国家卫生监督管理局(ANVISA)针对汉利康®以及汉曲优®的GMP符合性检查。


聚焦未满足的临床需求,复宏汉霖将持续夯实研产销一体化平台优势,稳步推进创新布局与出海进程,共同打造一个拥有更高价值的国际化生物制药平台,惠及全球更多患者。


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,已在中国上市5款产品,在国际上市1款产品,19项适应症获批,2个上市申请分别获美国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、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 Reported Financial Results for the First Three Quarters of 2023: Total Revenue Exceeded RMB3.9 Billion, Profitability Further Improved


Shanghai, China, November 15, 2023 - Henlius(2696.HK)announced its financial results and business update for the first three quarters of 2023. As of September 30, 2023, Henlius generated a total revenue of RMB3.9278 billion, rising by 84.0% YoY, and a profit totaled RMB407.8 million, attributed to the highly efficient commercial operation and successive growth in core products. Among which, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®) and HANSIZHUANG (serplulimab) gained sales revenues of RMB2.0145 billion and RMB865.4 million,respectively.


As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biologic medicines to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 self-developed products have been launched, benefiting over 495,000 patients and reaching more than 40 markets. Over 10 marketing applications have been accepted for review in the European Union (EU), the United States (U.S.), Canada, Brazil, Columbia, Indonesia, Singapore and other countries and regions.  


Wenjie Zhang, Chairman and Executive Director of Henlius, said: “During the first three quarters of 2023, Henlius delivered strong financial report, our integrated biopharmaceutical platform was further validated while the commercialisation potential gradually being unlocked. As we maximised the value of our products and continued our growth momentum, we have also strengthened our internal operations and management to enhance the foundations of high-quality development, working together to build a more valuable global biopharma.”


Jason Zhu, Chief Executive Officer, President and Chief Financial Officer, said: In 2023, we continued to address unmet clinical needs worldwide, and our strategy of innovation and globalisation has yielded remarkable results. Looking forward, we will adhere to our mission and fortify our core competencies, providing high-quality and accessible biologics to patients around the world.”


Keep robust momentum of commercialisation, actively expand global footprint 


In the third quarter of 2023, Henlius has maintained a positive growth momentum through the fast market penetration of its core products and achieved remarkable milestones, reaching a sales revenue of approximately RMB1.2256 billion. HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB737.8 million, RMB309.1 million and RMB36.4 million, respectively. In addition, the company received a profit-sharing of RMB131.0 million and RMB11.3 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.


Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefitting about 155,000 Chinese patients. Following the acceptance of the biologics license application (BLA) by the U.S. Food and Drug Administration (FDA), the Health Canada accepted the New Drug Submission (NDS) of HANQUYOU in July 2023. As of now, HANQUYOU has been launched in more than 40 countries, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia, making it the China-developed biosesimilar with the most marketing approvals.


HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). Since its launch in March 2022, HANSIZHUANG has earned wide recognitions and has seen rapid sales uptick with its breakthrough efficacy and differentiation advantages in the relevant treatment fields,benefitting about 43,000 Chinese patients. In September 2023, HANSIZHUANG has been approved for the first-line treatment of esophageal squamous cell carcinoma (ESCC), took a step forward in the company’s layout in the field of treatment of gastrointestinal tumours. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and ESCC. Henlius also plans to submit New Drug Application (NDA) for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the fourth quarter of 2023.


In 2023, Henlius has yielded remarkable results in global development and obtained new opportunities for growth. During the reporting period, the company earned approximately RMB546.7 million in overseas licensing and R&D services revenues, increasing by 232.1% YoY. Henlius deepened collaboration with partners to expand the global coverage of HANSIZHUANG. In September 2023, Henlius extended its collaboration with KGbio, the current partner on HANSIZHUANG in 10 ASEAN member countries, on the exclusive rights to develop and commercialise HANSIZHUANG in 12 Middle East and North African (MENA) countries. Henlius further expanded its collaboration with Intas in October 2023 to grant the company exclusive rights to develop and commercialise HANSIZHUANG in Europe and India, with a potential value of EUR€185 million.


Bolster competitiveness with relentless innovation and high quality 


Henlius continued its differentiated innovation and R&D layout, speeded up the innovation progress by strengthening internal innovation capabilities and external collaboration. Currently, Henlius has pro-actively built a diversified and high-quality product pipeline, including over 60 molecules across monoclonal antibody (mAb), bispecific antibody (BsAb), ADC, fusion protein, and small molecule drug conjugate, of which more than 80% are self-developed.


Henlius has actively expanded its differentiated advantages for HANSIZHUANG and has launched over 10 clinical trials of combination therapy worldwide with over 3,600 subjects enrolled globally. In the field of lung cancer treatment, the phase 3 clinical study of HANSIZHUANG as a first-line treatment for patients with advanced nsNSCLC has met the primary endpoint. While the first subjects have been dosed in two clinical trials including the international phase 3 clinical study of HANSIZHUANG in combination with chemotherapy and concurrent radiotherapy for the treatment of LS-SCLC, as well as the phase 2 clinical trial of HLX26 (anti-LAG-3 mAb) in combination with HANSIZHUANG and chemotherapy for the first-line treatment of advanced NSCLC. What’s more, the phase 1/2 clinical trial of HLX04-O was completed in patients with wet age-related macular degeneration (wAMD) in July 2023. 


Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, pursuing clinical trial approvals for a couple of potential first/best-in-class products. In October 2023, the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43 have been simultaneously approved by the National Medical Products Administration (NMPA), for the treatment of advance/metastatic solid tumours. And the results of the non-clinical studies of these two ADC candidates debuted at the 2023 European Society of Medical Oncology (ESMO) Congress. 


In 2023, Henlius continues to improve its production capacity and accessibility of the company’s products based on an integrated production platform, as well as a sound quality management system. The current commercial production capacity is 48,000 litres, forming synergy, and developing scale effects that allow the company to supply products stably to markets beyond China, including Europe and Latin America. Henlius is also constructing Songjiang Second Plant to further meet the global commercial production needs, with the total production capacity expected to reach 144,000 litres in 2026. In addition, 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 regulatory authorities and international business partners. Among which, Xuhui Facility has been certificated by China and the EU GMP while Songjiang First Plant obtained China GMP and the EU Qualified Person (QP) certification. In July 2023, Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU. In August 2023, Xuhui Facility has undergone the on-site GMP inspection conducted by Health and Youth Care Inspectorate (a health supervision agency in the Netherlands) for HANSIZHUANG before launch in EU, and part of Songjiang First Plant has also undergone the GMP extended inspection. In October 2023, Xuhui Facility successively passed the GMP Inspections for HANSIZHUANG by PIC/S Member Indonesia BPOM, and for HANLIKANG and HANQUYOU by PIC/S Member Brazil ANVISA.


Committed to meeting unmet medical needs, Henlius will further solidify its industry-leading capabilities in “integrated research, manufacturing and commercialisation”, consistently invest in innovation and foster global collaboration. By doing so, the company aims to evolve into a higher-value global biopharmaceutical, providing more affordable and better therapies for 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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in 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 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 biosesimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosesimilar 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.


联系方式

媒体:PR@Henlius.com

投资者:IR@Henlius.com

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ag尊龙凯时·人生就是博