[Translation] A randomized, double-blind, multicenter Phase III clinical study comparing the efficacy and safety of HLX03 and Humira? in patients with moderate to severe plaque psoriasis

主要目的：比较HLX03和阿达木单抗（修美乐®）治疗斑块状银屑病的有效性，确定两者的疗效是否等效。次要目的：评价比较HLX03和阿达木单抗治疗斑块状银屑病的安全性、耐受性和免疫原性。

[Translation]

Primary objective: To compare the efficacy of HLX03 and adalimumab (Humira®) in the treatment of plaque psoriasis and determine whether the two are equivalent in efficacy. Secondary objective: To evaluate and compare the safety, tolerability and immunogenicity of HLX03 and adalimumab in the treatment of plaque psoriasis.

Start Date27 Oct 2017

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT03316781

/ CompletedPhase 3

A Randomized, Double-blind, Multi-center, Parallel Control Phase 3 Study to Compare the Efficacy and Safety of Full Human Anti-TNF Alpha Antibody (HLX03) Versus Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods, including the screening period, treatment period and follow-up period. For each participating subjects, the maximal length of the study will be 56 weeks (including up to four weeks of screening time).

Start Date27 Oct 2017

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT03357939

/ CompletedPhase 1

A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects

This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

Start Date12 Jan 2017

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

100 Clinical Results associated with Adalimumab Biosimilar (Henlius Biotech)

100 Translational Medicine associated with Adalimumab Biosimilar (Henlius Biotech)

100 Patents (Medical) associated with Adalimumab Biosimilar (Henlius Biotech)

Literatures (Medical) associated with Adalimumab Biosimilar (Henlius Biotech)

01 Jan 2022·Advances in therapyQ3 · MEDICINE

Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study

Q3 · MEDICINE

Article

Author: Liu, Quanzhong ; Li, Shanshan ; Fang, Hong ; Cheng, Hao ; Zhang, Shifa ; Geng, Songmei ; Yang, Qinping ; Gao, Xinghua ; Zhang, Jianzhong ; Song, Zhiqi ; Guo, Qing ; Lu, Yan ; Li, Shenqiu ; He, Li ; Ding, Yangfeng ; Biao, Zhenshu ; Zhu, Jun ; Wang, Qingyu ; Deng, Danqi ; Han, Xiuping ; Cai, Lin ; Li, Linfeng ; Tao, Juan ; Gu, Jun

INTRODUCTION:

Adalimumab has been used successfully in the treatment of psoriasis. The objective of the study is to compare the efficacy, safety, and immunogenicity between HLX03, an adalimumab biosimilar, and adalimumab in Chinese patients with moderate-to-severe plaque psoriasis.

METHODS:

In this double-blind, active-controlled, parallel-group study, 262 patients with moderate-to-severe plaque psoriasis were randomized (1:1) to receive HLX03 or adalimumab (80 mg at week 1, 40 mg at week 2, and then 40 mg every 2 weeks) for 48 weeks. The primary endpoint was improvement in Psoriasis Area and Severity Index (PASI) score at week 16 comparing to baseline. Equivalence was demonstrated if 95% confidence interval (CI) of the between group difference fell within the equivalence margins of ± 15%. Other efficacy endpoints, safety and immunogenicity were also evaluated.

RESULTS:

In the full analysis set, PASI improvements at week 16 was 83.5% (n = 131) in the HLX03 group and 82.0% (n = 130) in the adalimumab group, with a least-square-mean difference of 1.5% (95% CI - 3.9% to 6.8%). There were no significant between-group differences in all secondary efficacy analyses including proportion of patients achieving ≥ 75% improvement from baseline PASI (PASI 75), physician global assessment (PGA) 0/1 (clear or almost clear) and change in dermatology life quality index (DLQI) score. The incidences of adverse events and the proportion of patients with antidrug antibodies were also comparable between the two treatment groups.

CONCLUSION:

HLX03 demonstrated equivalent efficacy, similar safety and immunogenicity to reference adalimumab, supporting its development as an alternative treatment for patients with plaque psoriasis in China.

CLINICAL TRIAL REGISTRATION:

Chinadrugtrials.org.cn, CTR20171123 (November 27, 2017); ClinicalTrials.gov, NCT03316781 (October 20, 2017).

01 Apr 2021·Pharmacology research & perspectivesQ4 · MEDICINE

Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

Q4 · MEDICINE

ArticleOA

Author: Ding, Yanhua ; Li, Xiaojiao ; Zhu, Xiaoxue ; Zhang, Hong ; Chai, Katherine ; Zhang, Xiaodi ; Sun, Jixuan ; Wu, Min ; Li, Cuiyun

Abstract:

The primary objective of this randomized, double‐blind, parallel‐controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volunteers, and to assess safety, and immunogenicity of HLX03. The primary PK endpoints were maximum observed plasma concentration (Cmax) and area under the concentration curve from time zero to the last quantifiable concentration (AUC0–t). Equivalence was determined if the 90% confidence interval (CI) of geometric least square mean ratio between the two treatment groups were within the predefined range of 80%–125%. Safety and immunogenicity were monitored during the study. Healthy Chinese males (N = 220) were randomized 1:1 to receive a single subcutaneous 40 mg dose of HLX03 or China (CN)‐sourced adalimumab. The ratios of the geometric mean of Cmax and AUC0–t were 102.2% and 105.7%, respectively, with corresponding 90% CIs falling in the predefined margins, which demonstrated PK equivalence between HLX03 and CN‐adalimumab. The incidence of treatment‐emergent adverse events (TEAEs) was similar in the two groups (73.8% and 66.0% in the HLX03 and CN‐adalimumab groups, respectively). Grade 3–4 TEAEs were reported in 7.5% and 5.7% of participants, respectively. The incidences of participants with antidrug antibodies (HLX03: 96.2%; CN‐adalimumab: 93.4%) or neutralizing antibodies (HLX03: 40.6%, CN‐adalimumab: 41.4%) were comparable between groups. This study demonstrated PK bioequivalence between HLX03 and CN‐adalimumab, with similar safety and immunogenicity profiles. These data support further clinical development of HLX03 as an adalimumab biosimilar.

01 May 2020·The AAPS journalQ3 · MEDICINE

Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®

Q3 · MEDICINE

Article

Author: Xie, Michael Hongwei ; Xie, Liqi ; Qin, Peilan ; Jiang, Weidong ; Xu, Yanpeng ; Wang, Linlin ; Lu, Lihong ; Liu, Scott ; Zhang, Erhui ; Gao, Wenyuan

Abstract:

Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, quality, and efficacy. Here, the analytical similarity of adalimumab biosimilar HLX03 to Humira® was successfully established following a QbD quality study. Quality target product profile (QTPP) of HLX03 was first generated according to the public available information and initial characterization of 3 batches of Humira®. The critical quality attributes (CQAs) were then identified through risk assessment according to impact of each quality attribute on efficacy and safety. The anticipated range for each CQA was derived from similarity acceptance range and/or the corresponding regulatory guidelines. Finally, a panel of advanced and orthogonal physicochemical and functional tests and comparison of 6 batches of HLX03 and 10 batches of the reference standard demonstrated high similarity of HLX03 to Humira®, except for slightly lower percentage of high mannosylated glycans (%HM) in HLX03 which had no effect on FcγRIII binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity in human peripheral blood mononuclear cell (PBMC). All above demonstrated the feasibility and efficiency of QbD-based similarity assessment of a biosimilar monoclonal antibody (mAb).

News (Medical) associated with Adalimumab Biosimilar (Henlius Biotech)

8 hours ago

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Henlius 2025 Global R&D Day: Harnessing the Power of Innovation to Propel Global Strategy to New Heights

SHANGHAI, April 16, 2025 /PRNewswire/ -- Henlius (2696.HK) held its 2025 Global R&D Day under the theme of "Collaborate to Create". Senior executives from Henlius gathered with leading experts, scholars, and heads of innovation from across the industry to engage in in-depth discussions on the latest advances in R&D, future strategic planning, and the deployment of cutting-edge technologies and therapies. The event drew hundreds of guests from academia, industry, and the investment community, making it a grand gathering of shared insight and collaboration. Jason Zhu, Executive Director and CEO of Henlius, stated: "At Henlius, we remain steadfast in our patient-centric philosophy and continue to strengthen our differentiated competitive edge through innovation-driven R&D. We are advancing the development of several key innovative assets, including HANSIZHUANG (serplulimab, anti-PD-1 mAb), HLX22 (anti-HER2 mAb), and HLX43 (PD-L1 ADC), with the potential to reshape the treatment landscape for lung and gastrointestinal cancers. Beyond that, we are actively exploring frontier technologies such as targeted therapies, immunotherapies, and glyco-editing, as we build a diversified innovation platform. In terms of global expansion, Henlius is strategically focused on major markets such as the U.S., EU, and Japan. Through full value chain integration and deepening international partnerships, we are making a strategic leap from exporting products to building a global value chain. Looking ahead, Henlius will continue to focus on antibody drug innovation, accelerate breakthroughs in targeted and immune therapies, and drive the global advancement of China's innovative biologics. Our goal is to deliver high-quality, affordable biologics to patients around the world while forging a sustainable, globally integrated value core." Jijun Yuan, CSO of Henlius, elaborated on the company's differentiated innovation strategy: "Henlius' R&D strength is reflected not only in our innovative pipeline but also in the continuous expansion of our platform capabilities. We focus on key therapeutic areas such as oncology and autoimmune diseases, extending our innovation reach to diverse modalities—including protein-based therapies, small molecules, and ADCs—to maximize synergistic potential across pipeline assets. Our three flagship technology platforms—the Hinova TCE (tri-specific T-cell engager) platform, the independently developed ADC platform Hanjugator™, and the AI-driven drug discovery platform HAI Club—have formed a collaborative R&D matrix. Leveraging these platforms and AI-driven approaches, we are accelerating the development of differentiated molecules, such as TCEs for solid tumors, to rapidly deliver more potential blockbuster therapies." In Henlius' innovative pipeline, late-stage clinical assets such as HLX22 and HLX43 have emerged as breakthrough candidates, underscoring the company's potential to drive future growth. Lixin Feng, Strategic Products Deputy GM of Henlius, shared that, "HLX43 is a precisely designed ADC targeting the pan-tumor antigen PD-L1. Its core framework incorporates the company's proprietary novel anti-PD-L1 mAb, combined with MediLink Therapeutics' innovative linker-toxin payload featuring a dual-release mechanism (intracellular and extracellular). As the world's second and China's first PD-L1 ADC to enter clinical development, HLX43 has demonstrated early potential as an innovative PIP (pipeline in a pill).Preclinical studies have shown favorable druggability and safety profiles with significant tumor-killing activity. Meanwhile, clinical studies of HLX43 as both monotherapy and in combination with HANSIZHUANG are accelerating across multiple solid tumors, with the potential to deliver superior treatment options for patients." At the event, Professor Lin Shen, the leading principal investigator of the MRCT Phase 3 trial for HLX22, remarked: "Henlius' HLX22 is a highly promising HER2-targeted therapy distinguished by both its mechanism of action and clinical performance. Its differentiated molecular design enables simultaneous binding to HER2 alongside trastuzumab, synergistically blocking all HER2 dimer formation and disrupting HER2-mediated signaling pathways. Moreover, HLX22's clinical development strategy is both pioneering and ambitious—it targets gastrointestinal cancers, a field with urgent unmet needs and high heterogeneity, where the drug has demonstrated exceptional antitumor efficacy. This positions HLX22 to potentially redefine first-line treatment for HER2-positive gastric cancer. HLX22 has demonstrated clinical development potential as a pan-tumor therapeutic for all HER2-positive cancers. We look forward to HLX22 benefiting more patients worldwide." Henlius is strategically advancing key innovations in biopharma by harnessing AI to sharpen its cutting-edge capabilities. Simon Hsu, CTO and SVP of Henlius, highlighted breakthroughs in AI-driven drug development, with a focus on next-generation hyaluronidase Henozye™, "Utilizing AI modeling, Henozye™ achieved significantly faster development cycles versus conventional methods while demonstrating superior enzyme activity and stability. Its exceptional performance across buffer systems and co-formulations provides critical support for subcutaneous delivery—overcoming injection volume limits to enable high-dose drug development," He emphasized that this hyaluronidase platform will transform the subcutaneous delivery market. "Through collaborative partnerships, we're accelerating subcutaneous formulations for both novel drugs and biosimilars, extending product lifecycles sustainably." While deepening its presence in Europe and the U.S. and expanding into emerging markets in Southeast Asia, Henlius is advancing its Globalization 2.0 strategy with a focused breakthrough in the Japanese market. Leveraging the advantages of geographic proximity and ethnic similarity for clinical development, along with Japan's status as the world's third-largest pharmaceutical market—supported by an aging population and a robust universal healthcare system—Henlius positions Japan as a strategic stronghold for the global rollout of its innovative biologics. Jin Li, Vice President of Henlius Regulatory Affairs, stated that "We are advancing our Internationalization 2.0 Strategy with Japan as a key market, leveraging the differentiated advantages of our core pipeline assets HLX22 (anti-HER2 mAb) and serplulimab (HLX10, anti-PD-1 mAb) in gastric cancer and lung cancer. We have initiated clinical trials in Japan to establish foundational support for indication development. Japan represents a strategic priority as a global pharmaceutical hub, offering unique opportunities through its aging population dynamics and innovative drug policy environment. We are systematically building local operational capabilities while strengthening our market position through innovative biologics. By integrating global clinical resources with localized strategies, we are creating an end-to-end value chain from clinical development to commercialization. As a Chinese biopharma innovator, we are reshaping the landscape in global markets through this approach." Henlius is committed to building a global innovation network and fostering an international collaborative ecosystem, setting a benchmark for partnerships spanning product development, market access, and localized operations. During the panel discussion moderated by Henlius SVP and Chief Business Development Officer, Ping Cao, 2022 Nobel Laureate and Palleon Co-founder Professor Carolyn Bertozzi, Palleon CEO James Broderick, MediLink CMO Steve Chin, KGbio CEO Sie Djohan and Sermonix Founder and CEO David Portman joined the discussion under the theme "Partnering for Success - Building a Global Biopharma Ecosystem." Professor Carolyn Bertozzi highlighted the critical role of sialoglycans in disease treatment, particularly their mechanism in tumor immune evasion and autoimmune diseases, as well as their vast potential as a cutting-edge global technology for novel drug development. Palleon is actively advancing its proprietary Enzyme-Antibody Glycan Ligand Editing (EAGLE) platform and has entered into collaborations with Henlius to develop bifunctional antibody-sialidase fusion proteins and human sialidase fusion protein HLX79 (E-602)—leveraging the EAGLE platform to target cancer and autoimmune diseases, respectively. During the follow-up discussion, panelists unanimously recognized Henlius' comprehensive capabilities spanning cutting-edge innovation, clinical development, and manufacturing excellence, while particularly commending the team's efficient collaboration and responsive partnership approach. Industry partners emphasized that their decision to collaborate with Henlius was rooted in strong confidence in the company's fully integrated biopharmaceutical platform that covers the entire value chain from research to commercialization. With established expertise in antibody development and a demonstrated ability to execute rapid yet reliable clinical strategies, Henlius has built a world-class manufacturing quality system meeting international standards, creating a robust foundation for global commercialization. Ping articulated the company's partnership philosophy: "We build on trust as our foundation, drive progress through efficiency, and connect through innovation." This guiding principle continues to shape Henlius' growing global collaborative ecosystem. Moving forward, the company remains committed to deepening complementary technology partnerships and accelerating exploration in frontier therapeutic areas. By leveraging its strong partner network, Henlius aims to enhance worldwide access to innovative therapies and deliver high-quality treatment solutions to patients across the globe. In biopharmaceutical R&D, the translational gap from preclinical research to clinical application remains a persistent challenge across the industry. For Henlius, this very gap represents a critical breakthrough point to truly deliver clinical benefit by staying centered on the patient. At the close of the event, Jijun Yuan moderated a panel discussion on the theme "From Discovery to Delivery: Patient-Centric Innovation in Practice." He was joined by Lei Tang, Head of Translational Medicine Unite China R&D at Sanofi; Li Peng, CSO of Palleon; Feng Ren, Co-CEO and CSO of Insilico; and Guoqiang Hua, Founder and Chairman of Dan1Med. Guests shared insights from the perspectives of multinational pharma, cutting-edge biotech, AI-driven biopharma company and technology platform company. Discussions spanned innovations in tools that enhance precision in clinical trial design, the acceleration of R&D through advanced AI-driven data strategies, and the current challenges faced. Ultimately, all perspectives converged on a shared vision: building a collaborative, barrier-free ecosystem is essential to truly achieving a seamless transition "from discovery to delivery." From biosimilars to first-in-class therapies, and from deepening presence in mainstream markets to expanding into multi-polar global markets, Henlius continues to push the boundaries of the industry with its multiple driving forces such as innovation and globalization. In 2025, Henlius will remain committed to its core theme of "Collaborate to Create", further powering its innovation engine to accelerate the transformation from technological strength to clinical value. The company aims to drive explosive growth across its innovative pipeline while advancing both technological breakthroughs and international collaboration. Looking ahead, Henlius will continue to write a new chapter for China's biopharmaceutical industry on the global stage—bringing Chinese innovation to contribute to the advancement of human health 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, 4 have been approved for marketing in overseas markets, and 5 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 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 about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include 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), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Immunotherapy

9 hours ago

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Putting Patients First, Co-Creating a Bright Future for Human Health: Henlius Releases 2024 ESG Report

SHANGHAI, April 16, 2025 /PRNewswire/ -- On April 15, 2025, Henlius (2696.HK) released the "2024 Environmental, Social, and Governance (ESG) Report" (hereinafter referred to as the "ESG Report" or "Report"). This marks the sixth consecutive year that the company has submitted an ESG-related report to global stakeholders, comprehensively showcasing Henlius' remarkable achievements and steadfast commitment across 5 key ESG pillars: Product, Talent, Environment, Society, and Corporate Governance. Together for Health Guided by patient needs, Henlius has consistently strengthened its R&D innovation. In 2024, R&D investment reached RMB1.8405 billion. To date, the company has successfully launched 6 products across about 50 countries and regions, benefiting over 750,000 patients. Henlius continues to focus on therapeutic areas such as oncology and autoimmune diseases, rapidly advancing about 50 pipeline molecules. The company has achieved broad coverage in high-incidence cancers such as lung cancer, colorectal cancer, gastric cancer, and esophageal squamous cell carcinoma. Additionally, it is actively developing 5 orphan drugs and rare disease treatments across multiple therapeutic areas, including oncology, chronic inflammatory, and neurological diseases. In terms of accessible healthcare, 5 of Henlius' products have been included in China's National Reimbursement Drug List (NRDL). Its trastuzumab biosimilar HANQUYOU has been covered by public health insurance in countries including China, the UK, France, and Germany. The PD-1 inhibitor HANSIZHUANG has been included in 118 provincial or municipal-level government-backed supplemental insurance programs (Huiminbao), making high-quality biologics more accessible. Furthermore, through collaborations with international partners such as Abbott and SVAX, Henlius is expanding into emerging markets like Latin America and the Middle East, bringing Chinese innovation to the world and improving global health. Together for Talent Growth Upholding a people-centric talent philosophy, Henlius is dedicated to building a diverse talent ecosystem. In 2024, women made up 53% of the workforce. The company released Diversity Policy and launched an internal platform called "H-Voice" to promote open, transparent communication and feedback channels. Henlius emphasized employee growth and development, supporting 144 employees in obtaining professional certifications. Through the online learning platform "Henlius Academy" and customized training programs, the company continues to build its talent pipeline and empower future development. In 2024, it reached an average training time of 70.37 hours per employee. In 2024, Henlius was recognized as one of HR Asia's Best Companies to Work for in Asia for the third consecutive year and was also awarded one of Universum's Most Attractive Employers for Chinese Students for the first time. Together for a Green Future Henlius understands the importance of green development and embeds environmental protection in its core values and practices. In 2024, the company invested RMB7.8445 million in environmental protection, up 26% year-over-year, underscoring its strong environmental commitment. Throughout the year, Henlius completed 230 lean improvement projects, achieving a 2.87% year-over-year reduction in comprehensive energy consumption, a 5.47% decrease in greenhouse gas emissions, and a 5.93% reduction in water consumption—contributing to cleaner air and water. The Songjiang Facility successfully passed ISO 14001:2015 environmental management system certification, a testament to its environmental standards in line with international best practices. Henlius also promoted green supply chain initiatives, with 80% of direct procurement suppliers signing on to green supply chain agreements, jointly advancing low-carbon transformation across the industry chain. Together for a Thriving Community Driven by its "patient-centric" public welfare philosophy, Henlius carried out numerous social care initiatives in 2024, with total charity donations reaching RMB134.84 million. The company continued its Breast Cancer Rural Healthcare Outreach Program, and hosted public awareness activities for breast cancer and International Lung Cancer Awareness Month, including a charity cycling event to promote healthy lifestyles and holistic patient care. In supply chain management, Henlius adopted BI systems to enhance transparency. 80% of its local suppliers are now introduced into its GMP system, resulting in approximately RMB55.65 million in procurement savings. This continuous effort drives cost reduction, efficiency improvement, and enhances the stability of the supply chain. Together for Stronger Governance Henlius builds its ESG strategy on a foundation of compliance and governance, supported by a four-tier ESG governance structure. In 2024, the company held 2 dedicated ESG meetings and hosted its first company-wide ESG Culture Month, further embedding ESG practices into its operations. Henlius remains committed to responsible operations, conducting 99 compliance training sessions with a total of 4,569 attendants, with 100% of employees signing the Compliance Commitment Letter. The commercial team received targeted responsible marketing training through 39 sessions with a total of 4,867 attendants. In 2024, Henlius filed 22 patent applications and got 10 invention or utility model patents granted. The company also passed the ISO 27001:2022 information security management system recertification. Driven by innovation, with accessibility as the goal, sustainability as the foundation, social responsibility as the driving force, and governance as the guarantee, Henlius continuously creates value for patients, employees, society, and the industry. Looking ahead, Henlius will stay true to its patient-centered mission, integrating ESG into its business development, and contributing more "Chinese strength" to global health to co-create a brighter future for human well-being. 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, 4 have been approved for marketing in overseas markets, and 5 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 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 about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include 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), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

06 Feb 2025

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Henlius and Dr. Reddy's Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S.

SHANGHAI, Feb. 6, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's") for the company's independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection. Dr. Reddy's will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.). Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy's is a global pharmaceutical company, operating in over 75 countries across the globe. Through a partnership with Dr. Reddy's, Henlius aims to boost the growth and reach of its products in the European and U.S. markets, providing local patients with enhanced treatment options. "This collaboration with Dr. Reddy's on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "Dr. Reddy's has a long-standing dedication to oncology, driven by the purpose that 'Good Health Can't Wait', and is committed to timely access to affordable and high-quality medicines, which complement Henlius' focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world." "We are pleased to join hands with Dr. Reddy's, signifying a pivotal moment in Henlius' journey to expand our global partner network," said Ping Cao, Chief Business Development Officer and SVP of Henlius, "Henlius' robust product development capabilities in biosimilars, along with its advanced manufacturing and quality systems that meet global standards, paired with Dr. Reddy's vast experience and resources in the global commercialization of biosimilars, positions this collaboration to effectively harness the strengths of both organizations. Together, we aim to deliver more high-quality and affordable treatment options to the U.S. and European markets." Erez Israeli, Chief Executive Officer of Dr. Reddy's, said: "We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S., and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options." About HLX15 HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to Darzalex® & Darzalex Faspro®* which are indicated for the treatment of multiple myeloma. In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the Phase 1 clinical study (NCT05679258) of HLX15 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab. Comparative efficacy studies are currently underway. *Darzalex® & Darzalex Faspro® are registered trademarks of Johnson & Johnson. About Dr. Reddy's Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . 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, 4 have been approved for marketing in overseas markets, and 4 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 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 the backbone. To date, the company's launched products include 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), HANSIZHUANG (serplulimab, trade name: Hetronifly® in the EU), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 Deals associated with Adalimumab Biosimilar (Henlius Biotech)

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Indication	Country/Location	Organization	Date
Crohn Disease	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 May 2024
Pediatric Crohn's Disease	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 May 2024
Plaque psoriasis	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 May 2024
Polyarticular Juvenile Idiopathic Arthritis	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 May 2024
Uveitis	China	Shanghai Henlius Biotech, Inc.	12 Apr 2021
Ankylosing Spondylitis	China	Shanghai Henlius Biotech, Inc.	02 Dec 2020
Psoriasis	China	Shanghai Henlius Biotech, Inc.	02 Dec 2020
Rheumatoid Arthritis	China	Shanghai Henlius Biotech, Inc.	02 Dec 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03316781 (Pubmed \| Adv Ther) Manual	Phase 3	Plaque psoriasis	262	Adalimumab (HLX03 group)	nchvyytftq(qlgemrhbmd) = jtbxpzrkcj brahwmzxvv (orpuuozlxg )	Positive	23 Nov 2021
				Adalimumab (adalimumab group)	nchvyytftq(qlgemrhbmd) = anznhbbsme brahwmzxvv (orpuuozlxg )

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