[Translation] A randomized, double-blind, multicenter Phase II clinical study evaluating the efficacy, safety, and tolerability of HLX53 (anti-TIGIT Fc fusion protein) combined with slulizumab injection (HLX10, a recombinant anti-PD-1 antibody) and HLX04 (bevacizumab biosimilar) versus placebo + slulizumab + HLX04 in patients with untreated locally advanced or metastatic HCC

PART A：主要目的：评估HLX53+HLX10 +HLX04 一线治疗晚期HCC中的安全性和耐受性次要目的：初步评估HLX53+HLX10+HLX04一线治疗晚期HCC中的临床疗效 PART B：主要目的：评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的临床疗效次要目的：初步评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的安全性和耐受性评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04治疗晚期HCC的潜在预测性生物标志物及耐药生物标志物

[Translation]

PART A: Primary purpose: To evaluate the safety and tolerability of HLX53+HLX10 +HLX04 in the first-line treatment of advanced HCC Secondary purpose: To preliminarily evaluate the clinical efficacy of HLX53+HLX10+HLX04 in the first-line treatment of advanced HCC PART B: Primary purpose: To evaluate the clinical efficacy of HLX53+HLX10+HLX04 vs. placebo+HLX10+HLX04 in the first-line treatment of advanced HCC Secondary purpose: Preliminary evaluation of the safety and tolerability of HLX53+HLX10+HLX04 vs. placebo+HLX10+HLX04 in the first-line treatment of advanced HCC Evaluate the potential predictive biomarkers and resistance biomarkers of HLX53+HLX10+HLX04 vs. placebo+HLX10+HLX04 in the treatment of advanced HCC

Start Date05 Aug 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT06491355 / Not yet recruitingPhase 2IIT

Efficacy and Safety of First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer: A Prospective, Multicenter, Randomized, Controlled Trial (ASTRUM-IUmCRC)

This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer.
This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

Start Date01 Jul 2024

Sponsor / Collaborator

Sir Run Run Shaw Hospital

NCT06349980 / Not yet recruitingPhase 2

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined With Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Start Date10 May 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

100 Clinical Results associated with Bevacizumab biosimilar(Shanghai Henlius)

100 Translational Medicine associated with Bevacizumab biosimilar(Shanghai Henlius)

100 Patents (Medical) associated with Bevacizumab biosimilar(Shanghai Henlius)

Literatures (Medical) associated with Bevacizumab biosimilar(Shanghai Henlius)

01 Sep 2024·Med

First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial

Article

Author: Wang, Feng ; Ke, Ying ; Cao, Bangwei ; Sun, Meili ; Yang, Liu ; Liang, Xinjun ; Luo, Suxia ; Li, Jing ; Zhang, Mingjun ; Jin, Yongdong ; Xu, Rui-Hua ; Wang, Qingyu ; Wang, Wei ; Chen, Kehe ; Deng, Yanhong ; Lin, Yuan ; Cheng, Ying ; Zhu, Jun ; Wang, Zi-Xian ; Peng, Junjie ; Li, Zhen ; Zhang, Jingdong ; Yu, Haoyu

BACKGROUND:

Whether or not the addition of immunotherapy to current standard-of-care treatments can improve efficacy in proficient mismatch repair (pMMR)/microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), the predominant type of mCRC, is unclear.

METHODS:

This randomized, double-blind, phase 2 part of a phase 2/3 trial was conducted at 23 hospitals across China (ClinicalTrials.gov: NCT04547166). Patients with unresectable metastatic/recurrent colorectal adenocarcinoma and no prior systemic therapy were randomly assigned 1:1 to receive every-3-weeks intravenous serplulimab (300 mg) plus HLX04 (7.5 mg/kg) and XELOX (serplulimab group) or placebo (300 mg) plus bevacizumab (7.5 mg/kg) and XELOX (placebo group). The primary endpoint was independent radiology review committee (IRRC)-assessed progression-free survival (PFS). Secondary endpoints included other efficacy endpoints and safety.

FINDINGS:

Between July 16, 2021, and January 20, 2022, 114 patients were enrolled and randomly assigned to the serplulimab (n = 57) or placebo (n = 57) group. All patients had stage IV CRC, and 95.7% of the patients with available microsatellite instability (MSI) status were MSS. With a median follow-up duration of 17.7 months, median PFS was prolonged in the serplulimab group (17.2 vs. 10.7 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.31-1.14). Although the median overall survival (OS) was not reached for either group, a trend of an OS benefit was observed for the serplulimab group (HR, 0.77; 95% CI, 0.41-1.45). 36 (65.5%) and 32 (56.1%) patients in the serplulimab and placebo groups had grade ≥3 treatment-related adverse events, respectively.

CONCLUSIONS:

Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.

FUNDING:

This work was funded by Shanghai Henlius Biotech, Inc.

01 Sep 2024·Med

Adding first-line PD-1 inhibition to anti-VEGF and XELOX in pMMR metastatic colorectal cancer: Steppingstones, stumbling blocks, and next phase

Article

Author: Søreide, Kjetil ; Veen, Torhild

In the randomized, double-blind, multicenter study by Wang et al.,¹ the addition of serplulimab (a PD-1 antibody) to anti-VEGF (HLX04; a bevacizumab biosimilar) together with chemotherapy (XELOX) was deemed to be tolerable and safe and may improve progression-free survival. However, even if adverse events were comparable, oncological endpoints including survival need to be confirmed in the next phase 3 study.

01 Jul 2023·Analytical and bioanalytical chemistry

Demonstrating analytical similarity of a biosimilar HLX04 to bevacizumab with a panel of state-of-the-art methods and tiering of quality attributes.

Article

Author: Fei, Mengdan ; Cao, Yanjing ; Wang, Hongya ; Yu, Lu ; Qin, Peilan ; Shen, Pengcheng ; Lu, Lihong ; Xu, Yanpeng ; Gao, Wenyuan ; Zhang, Lei ; Zhang, Zhongli ; Liu, Kemeng

Therapeutical monoclonal antibodies are structurally and functionally complex, whereas the innovator's manufacturing processes are proprietary. With respect to the similarity assessment, a proposed biosimilar product needs to demonstrate a side-by-side comparison between the reference product (RP) and candidate product in terms of physicochemical properties and biological activities, as well as nonclinical and clinical outcomes. Here, a comprehensive analytical similarity assessment was performed for in-depth comparison of HLX04, China-sourced Avastin^® (CN-Avastin^®), and Europe-sourced Avastin^® (EU-Avastin^®) following a tier-based quality attribute (QA) evaluation. A series of orthogonal and state-of-the-art analytical techniques were developed for the assessment. Ten lots of HLX04 were compared with 29 lots bevacizumab RP. Referred to the characterization results, HLX04 is highly similar to the RPs with respect to physicochemical properties and biological functions. In addition, HLX04 was found with similar stability and degradation behaviors upon multiple stressed conditions to bevacizumab. Minor differences were observed in glycosylation, aggregates, FcγRIIIa(F), and FcγRIIIa(V) binding activities; nevertheless, they were evaluated and demonstrated not to impact clinical outcomes. According to the reported clinical results, the totality of evidence, including the pharmacokinetic, efficacy, safety, and immunogenicity, further shows that HLX04 is similar to CN-/EU-Avastin^®.

News (Medical) associated with Bevacizumab biosimilar(Shanghai Henlius)

08 Nov 2024

·www.prnewswire.com

Henlius and SVAX Forge Strategic Partnership in the MENAT Market

SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity of Saudi Arabia's prominent family business group in the healthcare sector, the Fakeeh Family. The two parties will establish joint ventures in Saudi Arabia to integrate Henlius' leading capabilities in the research, development, and manufacturing of biologics with SVAX's local expertise in registration, market access, and commercialization. The collaboration seeks to advance the global registration and commercialization of multiple Henlius products and enhance the accessibility of advanced biologics across the Middle East, North Africa, and Türkiye (MENAT) countries, and benefit more patients. The signing ceremony was attended by Ms. Weilai Shen, Director of the Foreign Economic Cooperation Department of the Shanghai Municipal Commission of Commerce, Mr. Gang Ling, The Science and Economy Commission of the People's Government of Shanghai Pudong New Area, Mr. Qiyu Chen, Co-CEO of Fosun International, Mr. Yifang Wu, Chairman of Fosun Pharma, Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, Mr. Ammar Fakeeh, Chairman of the Family Business, and Prof. Mazen M. Hassanain, Founder and Managing Director of SVAX. According to the agreement, Henlius and SVAX will establish joint ventures for commercialization and manufacturing in Saudi Arabia and will collaborate on a series of Henlius products in the MENAT region, including HANDAYUAN (adalimumab, HLX03) and HANBEITAI (bevacizumab, HLX04), to conduct local commercial and manufacturing activities. In addition, the two parties will initially focus on jointly investing in the development of Henlius' investigational biosimilar of pembrolizumab, HLX17, to accelerate its global registration and commercialization. Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, stated, "Our collaboration with SVAX is a crucial step in Henlius' global blueprint, strengthening our presence in key markets while enhancing our international competitiveness. Through this partnership, we aim to drive innovation and growth for both parties, advance the research and manufacturing of high-quality biologics, and deliver more affordable therapies to patients in MENAT countries, thereby contributing to the global healthcare initiative. " Dr. Jason Zhu, CEO of Henlius, said, "We are delighted to collaborate with SVAX. This partnership not only complements our global strategy but also reaffirms our commitment to 'patient-centered' care. SVAX's dedication to innovation and improving regional healthcare closely aligns with Henlius' mission. Together, by combining SVAX's extensive resources and local expertise in MENAT with Henlius' global outlook and innovative capabilities, we are poised to bring more high-quality, innovative biologics to patients across the region and beyond." Mr. Ammar Fakeeh, Chairman of the Family Business, stated, "We are honored to forge this strategic partnership with Henlius, whose excellence in biopharmaceutical innovation perfectly complements our mission to elevate healthcare in the MENAT region. By joining forces, we are enhancing access to essential, high-quality biologics and strengthening the foundations of a resilient healthcare ecosystem in Saudi Arabia and beyond. This collaboration represents an important step forward in delivering advanced therapies to patients, embodying our commitment to health, innovation, and sustainable impact." Prof. Mazen Hassanain, Founder and Managing Director of SVAX, stated, "We at SVAX are delighted to enter this strategic partnership with Henlius, a company known for its commitment to high-quality and innovative biologic medicines. Combining our knowledge and experience in regulatory, marketing, sales, and local manufacturing with Henlius' expertise in biopharmaceutical development and global supply, we aim to bring cutting-edge therapies to the MENAT region and impact patients' lives. This partnership aligns with our dedication to advancing healthcare in the Kingdom of Saudi Arabia and beyond, fostering an ecosystem where life-changing therapies are accessible to those who need them. Together with Henlius, we look forward to driving growth, innovation, and healthcare accessibility across the region." As a global, innovative biopharmaceutical company, Henlius is dedicated to offering high-quality, affordable, and innovative biologic medicines for patients worldwide, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Henlius continuously enhances the development and operational efficiency of its integrated R&D, production, and commercialization platform. Through various measures to improve product accessibility, the company drives the commercial growth of core products and achieves sustained high-quality profitability. Henlius has proactively built a diversified, high-quality product pipeline covering over 50 molecules. Six products have been launched in China, three have been approved for marketing in overseas markets, and 24 indications are approved worldwide, benefiting over 670,000 patients. Specifically, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) has been approved in 49 countries and regions globally, making it the China-developed mAb biosimilar with the most marketing approvals and benefiting over 215,000 patients with breast and gastric cancer. Henlius collaborates with international partners to promote China's biopharmaceutical innovation and advance global development, with a presence across Asia, Europe, Latin America, North America, and Oceania. The MENAT region represents a significant part of the global pharmaceutical market. With growing healthcare needs and supportive government policies, the biopharmaceutical industry in the area is witnessing a rapid transformation. In June 2024, Zercepac® successfully shipped to Saudi Arabia, becoming the first China-developed monoclonal antibody (mAb) to enter the Middle Eastern market. The strong tie between Henlius and SVAX will help achieve joint development for the two parties and foster pharmaceutical innovation in emerging markets. Henlius remains committed to enhancing its global competitiveness, meeting global clinical needs, and spurring biopharmaceutical innovation. About SVAX SVAX is a pioneering Saudi company with a mission to localizing biomanufacturing within Saudi Arabia and ensuring a steady, high-quality supply of vaccines and biologics for the region. Established to bolster national health security, SVAX actively supports the region's preparedness for pandemics against infectious diseases. Aligned with Saudi Vision 2030 and the Saudi National Biotechnology Strategy, the company is at the forefront of nationalizing the biomanufacturing sector by employing highly skilled Saudi scientists and professionals. SVAX is distinguished as a local developer and manufacturer of essential biologics that serves Saudi Arabia and the broader MENAT region. The company operates through three strategic business segments: innovation, manufacturing, and advisory services. Its innovation efforts are focused on advanced R&D in biologics and vaccines, driving forward innovation and collaboration to bring cutting-edge therapies to market. In manufacturing, SVAX is establishing a state-of-the-art technologies and facilities to produce vaccines and biologics that meet global standards. Meanwhile, through its advisory services, SVAX offers expert consulting to support and accelerate the development of a strong biotech industry across the region. Through these initiatives, SVAX is uniquely positioned to drive transformative change in biomanufacturing, ensuring that the region remains resilient, innovative, and prepared for future healthcare challenges. 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 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 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. 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

01 Oct 2024

·pipelinereview.com

Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11

SHANGHAI, China & JERSEY CITY, NJ, USA I September 30, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study ( NCT05346224 ) aimed to compare the efficacy and safety of HLX11 with reference Perjeta ® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta ® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC). The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study was met. Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant, first-line, and adjuvant treatment for certain advanced HER2-positive breast cancer. 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. 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 proactively 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. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . SOURCE: Organon

Phase 3License out/inImmunotherapyClinical ResultDrug Approval

21 Sep 2024

·www.prnewswire.com

Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult patients with Extensive-Stage Small Cell Lung Cancer

- HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC - HETRONIFLY® (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC AHMEDABAD, India, Sept. 21, 2024 /PRNewswire/ -- Intas Pharmaceuticals Limited ("Intas") has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY® (serplulimab, approved as Hansizhuang in China), in European markets. Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug status designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC). Serplulimab will be commercialised by Intas through its subsidiary, Accord Healthcare Ltd (Accord), across more than 30 countries in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe. This positive opinion from CHMP marks another step closer for both Henlius and Intas to provide serplulimab for patients in Europe. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius' patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide." Paul Tredwell, Executive Vice President of EMENA at Accord, said "I am thrilled with the CHMP's positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis." Alex Falgas, Senior Vice President of Business Development at Accord said "The CHMP's positive opinion on serplulimab is a pivotal moment in our mission to provide world-class cancer treatments to patients in Europe. This strengthens our oncology portfolio and reinforces Accord's commitment to alleviating the global cancer burden, ensuring greater access to innovative therapies for those in need." According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer cases, and is associated with early metastasis, rapid disease progression, and an extremely poor prognosis. The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. References: [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 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. About Intas Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US. Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US. Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently; Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugImmunotherapyClinical Result

100 Deals associated with Bevacizumab biosimilar(Shanghai Henlius)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	03 Jan 2023
Ovarian Epithelial Carcinoma	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	03 Jan 2023
Primary peritoneal carcinoma	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	03 Jan 2023
Uterine Cervical Cancer	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	03 Jan 2023
Colorectal Cancer	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	30 Nov 2021
Non-Small Cell Lung Cancer	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	30 Nov 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Hepatocellular Carcinoma	Phase 3	CN	Shanghai Henlius Biotech, Inc.	15 Nov 2022
Wet age-related macular degeneration	Phase 3	RU	Shanghai Henlius Biotech, Inc.	06 Apr 2021
Metastatic Colorectal Carcinoma	Phase 3	JP	Shanghai Henlius Biotech, Inc.	10 Mar 2021
Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Shanghai Henlius Biotech, Inc.	12 Dec 2019
Squamous non-small cell lung cancer	Phase 3	CN	Shanghai Henlius Biotech, Inc.	02 Dec 2019
Portal Vein Thrombosis	Phase 2	-	Shanghai Henlius Biotech, Inc.	01 Aug 2021
Advanced Hepatocellular Carcinoma	Phase 2	CN	Shanghai Henlius Biotech, Inc.	24 Sep 2019
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Henlius Biotech, Inc.	27 Nov 2018
Ovarian Cancer	IND Application	CN	Shanghai Henlius Biotech, Inc.	11 Oct 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04547166 (ASCO_GI2024) Manual	Phase 2/3	Metastatic Colorectal Carcinoma First line Deficient DNA Mismatch Repair (dMMR) \| MSI-High \| Microsatellite Stable (MSS) \| ... View more	114	Serplulimab+HLX04+XELOX	iniklmrvpy(wxnhsrojje) = crenvgtpmh knjdtjngjk (nojhqatnxy ) View more	Positive	18 Jan 2024
				Placebo+ bevacizumab+ XELOX	iniklmrvpy(wxnhsrojje) = letwxqizgj knjdtjngjk (nojhqatnxy ) View more
NCT03973112 (ESMO_ASIA2023)	Phase 2	Advanced Hepatocellular Carcinoma	-	Serplulimab 3 mg/kg + HLX04 5 mg/kg	(ijggtewrms) = 10 (47.6%) patients in group C and 29 (47.5%) in group D reported grade ≥3 treatment-emergent adverse events owcjtrzwpw (sycvufwtma ) View more	-	02 Dec 2023
				Serplulimab 3 mg/kg + HLX04 10 mg/kg
NCT04993352 (Pubmed) Manual	Phase 1/2	Wet age-related macular degeneration	1	HLX04-O	gxkmnypqmn(lfpvsigwoi) = tmyusbelgo sqxbqodkpx (bnieqvazhn ) View more	Positive	18 Sep 2022
NCT03973112 (Corporate Publications) Manual	Phase 2	Advanced Hepatocellular Carcinoma	41	Serplulimab 3 mg/kg+HLX04 5 mg/kg	qkzfbbunjw(mitwdqhbue) = udzxiljnpo besdrvcpxi (pdtvhuhdzm ) View more	Positive	30 Aug 2022
				Serplulimab 3 mg/kg+HLX04 10 mg/kg	qkzfbbunjw(mitwdqhbue) = tcnvneacrk besdrvcpxi (pdtvhuhdzm ) View more
NCT03511963 (HLX04-mCRC03, Corporate Publications) Manual	Phase 3	Colorectal Cancer First line	675	Chemotherapy+HLX04	xeabvcpnqn(fpybvfafyb) = eqopkobcxf fztekuvdym (ohkoolpacy ) View more	Similar	26 Sep 2021
				Chemotherapy+bevacizumab	xeabvcpnqn(fpybvfafyb) = neeaaqwkpd fztekuvdym (ohkoolpacy ) View more
HLX04-mCRC03 (CSCO2021)	Phase 3	Metastatic Colorectal Carcinoma First line	677	HLX04	oeuvyzfwei(njklutsbvf) = uiuvkdcwbi ncrfgzcftn (dfxrauhhnt ) View more	Positive	25 Sep 2021
				Reference bevacizumab	oeuvyzfwei(njklutsbvf) = dheumjxbzf ncrfgzcftn (dfxrauhhnt ) View more
NCT03511963 (HLX04-mCRC03, Pubmed) Manual	Phase 3	Metastatic Colorectal Carcinoma First line	677	XELOX or mFOLFOX6+HLX04	upzjnxvsao(wmilwyuaza) = bgswcnvqsc uswyefvdjt (veptdeynaj, 41.1 - 51.8)	Similar	01 Jul 2021
				XELOX or mFOLFOX6+Bevacizumab	upzjnxvsao(wmilwyuaza) = ahwvfaaqlp uswyefvdjt (veptdeynaj, 45.4 - 56.1)
NCT03511963 (HLX04-mCRC03, ESMO_ASIA_VIRTUAL2020)	Phase 3	Metastatic Colorectal Carcinoma First line	675	HLX04	qdbsjjpbxf(pjlbmfjjom) = ifhmiilduo vhsklyamvz (imhmcdtslf )	Positive	22 Nov 2020
				Bevacizumab	qdbsjjpbxf(pjlbmfjjom) = okptbbflcf vhsklyamvz (imhmcdtslf )
HLX04-mCRC03 (ESMO_ASIA2018)	Phase 3	Metastatic Colorectal Carcinoma First line	640	HLX04	vnxzamwgeg(ddahphjwkx) = dojnyshgrr qbjxexlxbu (swcpiluufj )	Positive	24 Nov 2018
				Avastin® sourced from US, EU or CN	vnxzamwgeg(ddahphjwkx) = zbwebrsdks qbjxexlxbu (swcpiluufj )

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