[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.

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.

IRCT20220423054625N1 / SuspendedPhase 3IIT

Comparison of clinical outcomes after combined therapy of bevacizumab intravitreal injection and topical diclofenac with bevacizumab intravitreal injection alone in diabetic macular edema

Start Date21 Dec 2023

Sponsor / Collaborator-

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 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 ; Liu, Kemeng ; Zhang, Zhongli

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^®.

01 Jan 2023·Journal of pharmaceutical and biomedical analysis

Development and validation of aggregates analysis method in analytical similarity assessment of HLX04 vs Avastin®

Article

Author: Zhu, Xiaoqi ; Zhang, Qiang ; Du, Chaofu ; Zhang, Lei ; Fei, Mengdan ; Zhang, Zhongli

Aggregate of therapeutic antibodies is usually considered as one of the most important critical quality attributes (CQA). The propensity of aggregates formation for bevacizumab is higher than other monoclonal antibody (mAb) drugs due to its tendency of self-association via the non-covalent interaction between the Fab arm of one bevacizumab molecule and the K445 residue on the heavy chain of another bevacizumab molecule. HLX04 has been developed as a biosimilar to bevacizumab (Avastin®) by Shanghai Henlius Biotech. To perform a head-to-head similarity evaluation with respect to aggregates or higher molecular weight species (HMWS) between HLX04 and Avastin®, we developed a robust high performance liquid chromatography (SEC-HPLC) method for aggregates analysis. Our characterization data indicated that HMWS of bevacizumab were mainly composed of dimers, and the dimer formation-dissociation equilibrium was influenced by protein concentration and storage temperature. Based on the characterization data of aggregates, we optimized the key parameters for SEC-HPLC based aggregates analysis method including mobile phase components and pH, autosampler temperature, as well as incubation conditions for sample pretreatment. The developed method was applied in HLX04 and Avastin® aggregates assessment and the similarity were confirmed among HLX04, China-sourced, and Europe-sourced Avastin® using both the pharmaceutical dosage forms and forced degradation samples. The method was also validated per ICH Q2 (R1) guidelines by challenging the parameters including specificity, accuracy, precision, linearity, range, limit of quantitation, and robustness. The validated method was applied in release test and stability study of HLX04 samples generated from commercial manufacturing process.

01 Jan 2023·Liver cancer

Phase 2 Study of the PD-1 Inhibitor Serplulimab plus the Bevacizumab Biosimilar HLX04 in Patients with Previously Treated Advanced Hepatocellular Carcinoma

Article

Author: Shao, Guoliang ; Yin, Tao ; Shen, Jie ; Zhu, Xu ; Fang, Weijia ; Zhang, Li ; Sun, Guoping ; Liu, Lianxin ; Fan, Jia ; Ren, Zhenggang ; Zhu, Jun ; Zhang, Ling ; Wang, Qingyu ; Zhang, Jingdong ; Bai, Yuxian ; Hou, Xiaoli ; Yuan, Yuan ; Wu, Jianbing ; Li, Zhen ; Wu, Jincai

Introduction: Current treatments for patients with previously treated advanced hepatocellular carcinoma (HCC) provide modest survival benefits. We evaluated the safety and antitumor activity of serplulimab, an anti-PD-1 antibody, plus the bevacizumab biosimilar HLX04 in this patient population. Methods: In this open-label, multicenter, phase 2 study in China, patients with advanced HCC who failed prior systemic therapy received serplulimab 3 mg/kg plus HLX04 5 mg/kg (group A) or 10 mg/kg (group B) intravenously every 2 weeks. The primary endpoint was safety. Results: As of April 8, 2021, 20 and 21 patients were enrolled into groups A and B, and they had received a median of 7 and 11 treatment cycles, respectively. Grade ≥3 treatment-emergent adverse events were reported by 14 (70.0%) patients in group A and 12 (57.1%) in group B. Most immune-related adverse events were grade ≤3. The objective response rate was 30.0% (95% confidence interval [CI], 11.9–54.3) in group A and 14.3% (95% CI, 3.0–36.3) in group B. Median duration of response was not reached (95% CI, 3.3–not evaluable [NE]) in group A and was 9.0 months (95% CI, 7.9–NE) in group B. Median progression-free survival was 2.2 months (95% CI, 1.4–5.5) and 4.1 months (95% CI, 1.5–NE), and median overall survival was 11.6 months (95% CI, 6.4–NE) and 14.3 months (95% CI, 8.2–NE) in groups A and B, respectively. Conclusion: Serplulimab plus HLX04 showed a manageable safety profile and promising antitumor activity in patients with previously treated advanced HCC.

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

12 Aug 2024

·pipelinereview.com

First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

SHANGHAI, China I August 8, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe [1] . Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases [2] . Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has been in its locally advanced stage or develops distant metastasis when it is diagnosed. As a result, the management becomes extremely difficult and the prognosis usually is poor. The 5-year survival rate of PLC is only about 18% [3] . For patients with advanced liver cancer, the first-line treatment is based on targeted therapy and immunotherapy. And the standard therapy (combination therapies of immune inhibitor plus anti-angiogenic treatment) have shown significant clinical anti-tumour efficacy and survival benefit [2] . However, some patients failed to benefit from the standard therapy and suffered from recurrence or progression of the disease. Thers is still an urgent clinical need to further expand the benefit population with advanced liver cancer and improve the efficacy of immunotherapy. T-cell immunoglobulin and ITIM domains (TIGIT) has emerged as popular inhibitory checkpoint receptor, which is mainly expressed on natural killer (NK) cells, activated CD8+ T and CD4+ T cells, and T regulatory cells. TIGIT binds to the ligand CD155 (poliovirus receptor, PVR) [4] , mainly expressed on antigen-presenting cells (APC) or the surface of tumour cells, to down-regulate T cell and NK cell functions. As an immune checkpoint protein, TIGIT can inhibit innate and adaptive responses in various mechanisms of action and act as “brakes” like PD-1/PD-L1 does to stop T cells from attacking tumours. Studies have shown that TIGIT inhibitor are effective against lung cancer, gastric cancer, melanoma, multiple myeloma, etc. Moreover, TIGIT has shown a synergistic effect with the PD-1 pathway in preclinical studies, indicating that simultaneous blocking of TIGIT and PD-1/PD-L1 signaling pathways is superior to blocking either pathway alone, which can enhance anti-tumour activity [5] . HLX53 is an anti-TIGIT Fc fusion protein independently developed by Henlius, consisting of variable domain of heavy chain of heavy-chain antibody (VHH) and wildtype IgG1 Fc. Pre-clinical studies have demonstrated that HLX53 exhibits excellent tumour inhibition with good safety. In addition, Henlius has initiated a phase 1 study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of HLX53 in patients with advanced/metastatic solid tumors. Considering the good efficacy of immune checkpoint inhibitor such as anti-PD-1/PD-L1 antibody plus anti-angiogenic drug in the first-line treatment of patients with advanced HCC, as well as the synergistic effect of TIGIT and PD-1/PD-L1 signaling pathway, Henlius intends to further combine TIGIT inhibitor based on the standard therapy in order to bring greater clinical benefits to patients with advanced HCC. Underpinned by the patient-centric strategy, Henlius has achieved an overall layout of the immune checkpoint products of PD-1/L1, CTLA-4, LAG-3, etc., proactively exploring immuno-oncology combination therapy. Meanwhile, Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies in a wide variety of indications, committing to bringing affordable and high-quality innovative biologics to patients around the world. [1] Globocan 2022 (version 1.1) – 08.02.2024；https://gco.iarc.fr/today/en/dataviz/bars-compare-populations?mode=cancer&group_populations=1&cancers=11&populations=900&sort_by=value1&types=0_1&key=total [2]原发性肝癌诊疗指南（2024年版） [3] Asafo-Agyei KO, Samant H. Hepatocellular Carcinoma. 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID: 32644603. [4] Chauvin, Joe-Marc, and Hassane M Zarour. “TIGIT in cancer immunotherapy.” Journal for immunotherapy of cancer vol. 8,2 (2020): e000957. doi:10.1136/jitc-2020-000957. [5] Chu, Xianjing et al. “Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.” Molecular cancer vol. 22,1 93. 8 Jun. 2023, doi:10.1186/s12943-023-01800-3. About NCT05483530 This randomised, double-blind, multicentre phase 2 clinical study aims to evaluate the efficacy, safety, and tolerability of HLX53 in combination with HANSIZHUANG and HANBEITAI versus placebo in combination with HANSIZHUANG and HANBEITAI in previously untreated patients with locally advanced or metastatic hepatocellular carcinoma. The study consists of two parts. Part A is the safety run-in stage, which follows a “3+3” dose-escalation design. Eligible patients will be given different doses of HLX53 (1000 mg or 2000 mg) in combination with HANSIZHUANG (300 mg) and HANBEITAI (15 mg/kg) intravenously, every three weeks. Part B is the preliminary efficacy exploration stage. Eligible patients will be randomly assigned (1:1:1) to receive intravenous HLX53 (1000 mg), HLX53 (2000 mg), or placebo in combination with HANSIZHUANG (300 mg) and HANBEITAI (15 mg/kg), every three weeks. The primary endpoints of Part A are safety and tolerance， evaluating the proportion of patients with a dose-limiting toxicity (DLT) event in each group. The primary endpoints of Part B are objective response rate and progression-free survival assessed by independent radiological review committee per RECIST v1.1. SOURCE: Shanghai Henlius Biotech

ImmunotherapyPhase 2Phase 1Clinical Result

24 May 2024

·www.biospace.com

European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1 This press release features multimedia. View the full release here: The submissions were based on a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study that aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture. In 2022, Henlius entered into a license and supply agreement with Organon granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the European Union, the United States, and Canada. An exception to the agreement is China. 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, 2 have been approved for marketing in overseas markets, 23 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 center and Shanghai-based manufacturing facilities certified 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 for injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), 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. To learn more about Henlius, visit or connect with us on LinkedIn at . 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 and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding marketing authorization applications and prospects for Prolia® and Xgeva® (denosumab) biosimilar products in Europe, as well as the future business plans of Henlius and Organon. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on Organon’s current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon’s plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect Organon’s future results include, but are not limited to, an inability to market Prolia® and Xgeva® (denosumab) biosimilar throughout Europe; an inability to fully execute on the product development and commercialization plans for Prolia® and Xgeva® (denosumab) biosimilar throughout Europe and worldwide; the performance, operations and regulatory compliance of Henlius and its suppliers, efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures or regulatory developments, that adversely impact demand for, availability of, or patient access to Organon’s products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the Europe and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining further regulatory approval; Organon’s ability to accurately predict its future performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( ). 1 J. Kanis, Norton, N., Harvey, N., et al. SCOPE 2021: a new scorecard for osteoporosis in Europe. Archives of Osteoporosis. (2021) 16:82. Accessed 6 May 2024. Available at . View source version on businesswire.com: Contacts Organon Media Contacts: Felicia Bisaro (646) 703-1807 Hannah Silver (917) 509-8864 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Henlius Media Contacts: Bella Zhou wenting_zhou@henlius.com Janice Han jiayi_han@henlius.com Source: Organon & Co. View this news release online at:

Phase 3License out/inDrug ApprovalImmunotherapy

08 Apr 2024

·www.biospace.com

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. This press release features multimedia. View the full release here: The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint of this study was the percentage change in bone mineral density (BMD) at the lumbar spine from baseline to Week 52 (D365) assessed by central imaging. The primary pharmacodynamic endpoint was the area under the effect–time curve for percentage change of serum type I collagen C-telopeptide (s-CTX) from baseline to Week 26 (D183) (AUEC0–26W). The primary endpoints of this study were met. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. 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, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 7 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU 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 for injection, trade name in Europe: Zercepac®), 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 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. To learn more about Henlius, visit or connect with us on LinkedIn at . 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 and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding Organon’s license and supply agreement with Henlius. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on Organon’s current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon’s plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect Organon’s future results include, but are not limited to, our inability to successfully commercialize products in our biosimilars portfolio, the performance, operations and regulatory compliance of Henlius and its suppliers, efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures or regulatory developments, that adversely impact demand for, availability of, or patient access to Organon’s products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( ). View source version on businesswire.com: Contacts Organon Media Contacts: Karissa Peer (614) 314-8094 Hannah Silver (917) 509-8864 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Alex Arzeno (203) 550-3972 Henlius Media Contacts Bella Zhou wenting_zhou@henlius.com Janice Han jiayi_han@henlius.com Source: Organon & Co. View this news release online at:

Phase 3Clinical ResultLicense out/inImmunotherapyDrug Approval

100 Deals associated with Bevacizumab biosimilar(Shanghai Henlius)

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

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 AMD	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
Carcinoma	Phase 3	CN	Shanghai Henlius Biotech, Inc.	02 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

Clinical Result

Indication

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Evaluation

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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	cpsgcphpej(zxkocnqskw) = rkkzzkbvej gkfhpqxznw (bkgppimbnz ) View more	Positive	18 Jan 2024
				Placebo+ bevacizumab+ XELOX	cpsgcphpej(zxkocnqskw) = fxtlevyjfp gkfhpqxznw (bkgppimbnz ) View more
NCT03973112 (ESMO_ASIA2023)	Phase 2	Advanced Hepatocellular Carcinoma	-	Serplulimab 3 mg/kg + HLX04 5 mg/kg	(lbqacqgpeu) = 10 (47.6%) patients in group C and 29 (47.5%) in group D reported grade ≥3 treatment-emergent adverse events xijpomcmck (uazplxruvq ) View more	-	02 Dec 2023
				Serplulimab 3 mg/kg + HLX04 10 mg/kg
NCT04993352 (Pubmed) Manual	Phase 1/2	Wet AMD	1	HLX04-O	phttkydzmd(okegidfdan) = ugzcfktgik kewtkxxdxv (lujyvynydi ) View more	Positive	18 Sep 2022
NCT03973112 (Corporate Publications) Manual	Phase 2	Advanced Hepatocellular Carcinoma	41	Serplulimab 3 mg/kg+HLX04 5 mg/kg	byutaxhgtb(ancefmbfah) = zuhvsnpuup iwhnvqdrvr (fkisgsrekd ) View more	Positive	30 Aug 2022
				Serplulimab 3 mg/kg+HLX04 10 mg/kg	byutaxhgtb(ancefmbfah) = yifaozdpmx iwhnvqdrvr (fkisgsrekd ) View more
NCT03511963 (HLX04-mCRC03, Corporate Publications) Manual	Phase 3	Colorectal Cancer First line	675	Chemotherapy+HLX04	usrmwmizbv(avrxmiqqgj) = veazrhorkz kewhtgkxru (khqwobhite ) View more	Similar	26 Sep 2021
				Chemotherapy+bevacizumab	usrmwmizbv(avrxmiqqgj) = swyzsjwnyu kewhtgkxru (khqwobhite ) View more
HLX04-mCRC03 (CSCO2021)	Phase 3	Metastatic Colorectal Carcinoma First line	677	HLX04	hczpisowni(zinnxgmgom) = phiskajmnl eefqvgjtfc (zfkwiqmpdb ) View more	Positive	25 Sep 2021
				Reference bevacizumab	hczpisowni(zinnxgmgom) = hcjevyhoau eefqvgjtfc (zfkwiqmpdb ) View more
NCT03511963 (HLX04-mCRC03, Pubmed) Manual	Phase 3	Metastatic Colorectal Carcinoma First line	677	XELOX or mFOLFOX6+HLX04	jjiypuoffr(dahuojrsqx) = rwpvobpqen xbkguqosrt (ppcuwgalmp, 41.1 - 51.8)	Similar	01 Jul 2021
				XELOX or mFOLFOX6+Bevacizumab	jjiypuoffr(dahuojrsqx) = hoxxfagjhp xbkguqosrt (ppcuwgalmp, 45.4 - 56.1)
NCT03511963 (HLX04-mCRC03, ESMO_ASIA_VIRTUAL2020)	Phase 3	Metastatic Colorectal Carcinoma First line	675	HLX04	egnjpokplc(wuetutlwwx) = ucimwugcnq wdruqrtyvm (agbznulmzn )	Positive	22 Nov 2020
				Bevacizumab	egnjpokplc(wuetutlwwx) = jshsrnygwj wdruqrtyvm (agbznulmzn )
HLX04-mCRC03 (ESMO_ASIA2018)	Phase 3	Metastatic Colorectal Carcinoma First line	640	HLX04	fteaqoyqqj(bghbglzjvx) = mlkebsgtuv uxzmlxxurv (zrovhzqpty )	Positive	24 Nov 2018
				Avastin® sourced from US, EU or CN	fteaqoyqqj(bghbglzjvx) = ynbfquukgx uxzmlxxurv (zrovhzqpty )

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