[Translation] A randomized, double-blind, multicenter, phase III clinical study of HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) combined with trastuzumab and chemotherapy (XELOX) versus trastuzumab and chemotherapy (XELOX) with or without pembrolizumab as first-line treatment for locally advanced or metastatic gastroesophageal junction and gastric cancer

主要目的：评估 HLX22 联合曲妥珠单抗+ 化疗对比曲妥珠单抗+ 化疗±帕博利珠单抗作为一线治疗在局部晚期或转移性胃食管交界部和胃癌患者中的疗效。次要目的：评估 HLX22 联合曲妥珠单抗+ 化疗对比曲妥珠单抗+ 化疗±帕博利珠单抗作为一线治疗在局部晚期或转移性胃食管交界部和胃癌患者中的安全性；观察 HLX22 的药代动力学（PK）特征。

[Translation]

Primary objective: To evaluate the efficacy of HLX22 combined with trastuzumab + chemotherapy versus trastuzumab + chemotherapy ± pembrolizumab as first-line treatment in patients with locally advanced or metastatic gastroesophageal junction and gastric cancer. Secondary objective: To evaluate the safety of HLX22 combined with trastuzumab + chemotherapy versus trastuzumab + chemotherapy ± pembrolizumab as first-line treatment in patients with locally advanced or metastatic gastroesophageal junction and gastric cancer; To observe the pharmacokinetic (PK) characteristics of HLX22.

Start Date08 Nov 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

[+1]

NCT06532006 / Not yet recruitingPhase 3

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Start Date01 Nov 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

NCT04908813 / Active, not recruitingPhase 2

A Randomized, Double-blinded，Multicenter，Phase II Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Placebo in Combination With Trastuzumab and Chemotherapy (XELOX) for Treatment of Locally Advanced or Metastatic Gastric Cancer (GC)

The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2+ Locally Adanved or Metastatic Gastric Cancer as the first-line therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX22/placebo and SOC(standard of care: Trastuzumab + XELOX) once every 3 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol(whichever occurs earlier).

Start Date29 Sep 2021

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

100 Clinical Results associated with HLX-22

100 Translational Medicine associated with HLX-22

100 Patents (Medical) associated with HLX-22

Literatures (Medical) associated with HLX-22

01 Oct 2024·Med

A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer

Article

Author: Qiu, Meng ; Chen, Ye ; Deng, Jun ; Liu, Zimin ; Huo, Zhibin ; Cai, Mingquan ; Zhu, Jun ; Zhong, Diansheng ; Hou, Xiaoming ; Wang, Jingran ; Lu, Jianwei ; Li, Jin ; Yang, Mudan ; Lu, Linzhi ; Ma, Yuntao ; Li, Wei ; Zhang, Jingdong ; Yang, Futang ; Sun, Guoping ; Yin, Xianli ; Zhang, Yanqiao ; Wang, Qingyu ; Yu, Haoyu ; Li, Jing ; Pan, Hongming ; Li, Ning

BACKGROUND:

Gastric cancer is the fifth most common cancer and the fourth most common cause of cancer death worldwide, yet the prognosis of advanced disease remains poor.

METHODS:

This was a randomized, double-blinded, phase 2 trial (ClinicalTrials.gov: NCT04908813). Patients with locally advanced/metastatic HER2-positive gastric/gastroesophageal junction cancer and no prior systemic antitumor therapy were randomized 1:1:1 to 25 mg/kg HLX22 (a novel anti-HER2 antibody) + HLX02 (trastuzumab biosimilar) + oxaliplatin and capecitabine (XELOX) (group A), 15 mg/kg HLX22 + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were progression-free survival (PFS) and objective response rate (ORR) assessed by independent radiological review committee (IRRC).

FINDINGS:

Between November 29, 2021, and June 6, 2022, 82 patients were screened; 53 were randomized to group A (n = 18), B (n = 17), and C (n = 18). With 14.3 months of median follow-up, IRRC-assessed median PFS was prolonged with the addition of HLX22 (A vs. C, 15.1 vs. 8.2 months, hazard ratio [HR] 0.5 [95% confidence interval (CI) 0.17-1.27]; B vs. C, not reached vs. 8.2 months, HR 0.1 [95% CI 0.04-0.52]). Confirmed ORR was comparable among groups (A vs. B vs. C, 77.8% vs. 82.4% vs. 88.9%). Treatment-related adverse events (TRAEs) were observed in 18 (100%), 16 (94.1%), and 17 (94.4%) patients, respectively. One (5.6%) patient in group C reported a grade 5 TRAE.

CONCLUSIONS:

Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.

FUNDING:

Shanghai Henlius Biotech, Inc.

01 Oct 2024·Med

Dual HER2 inhibition: Is two better than one?

Article

Author: Strickland, Matthew R ; Klempner, Samuel J. ; Strickland, Matthew R. ; Klempner, Samuel J

Li et al. present data from a randomized frontline phase II trial in HER2+ gastroesophageal cancers exploring dual targeting of HER2 with HLX22 (a novel HER2-specific antibody) with HLX02 (a trastuzumab biosimilar) and capecitabine/oxaliplatin chemotherapy. While the objective response and progression-free survival are encouraging, the future development of the combination in a crowded HER2 space remains unclear.

01 Jun 2023·Investigational new drugs

HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial.

Article

Author: Yang, Guiyu ; Ding, Yanhua ; Wang, Qian ; Wang, Qingyu ; Zhou, Liang ; Zhu, Xiaoxue

HLX22 is a novel monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2). This first-in-human, phase 1 dose-escalation study aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HLX22 in patients with advanced solid tumors who had failed or were intolerant to standard therapies. Enrolled patients aged 18 to 75 years with histologically confirmed HER2-overexpressing advanced or metastatic solid tumors received intravenous HLX22 once every 3 weeks at 3, 10, and 25 mg/kg. Primary endpoints were safety and the maximum tolerated dose (MTD). Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy. Between July 31, 2019, and December 27, 2021, 11 patients were enrolled to receive HLX22 at 3 (n = 5), 10 (n = 3), and 25 (n = 3) mg/kg doses. The most common treatment-emergent adverse events were lymphocyte count decreased (45.5%), white blood cell count decreased (36.4%), and hypokalemia (36.4%). No serious adverse events or dose-limiting toxicities occurred during the treatment period, and the MTD was determined at 25 mg/kg once every 3 weeks. Systemic exposure of HLX22 increased with escalating dose levels. No patients achieved a complete or partial response, and four (36.4%) had stable disease. The disease control rate and median progression-free survival were 36.4% (95% confidence interval [CI], 7.9-64.8) and 44.0 days (95% CI, 41.0-170.0), respectively. HLX22 was well tolerated in patients with advanced solid tumors overexpressing HER2 after failure of standard therapies. The study results support further investigation of HLX22 in combination with trastuzumab and chemotherapy.

News (Medical) associated with HLX-22

06 Dec 2024

·pipelinereview.com

China NMPA Accepts Henlius' NDA for HLX11, an Pertuzumab Biosimilar Candidate

SHANGHAI, China I December 04, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11, in combination with trastuzumab and chemotherapy, as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, and in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China, the United States (U.S.) and the European Union (EU). The filing was based on data from a series of head-to-head studies of HLX11 in comparison with reference pertuzumab, including analytical studies of similarities, phase 1 clinical studies and international multicenter phase 3 clinical studies. These data demonstrated that HLX11 is highly similar to the reference pertuzumab in terms of quality, safety and efficacy. Breast cancer is the second most common tumour worldwide and the most common cancer among women globally. According to GLOBOCAN, there were 2.3 million new cases of breast cancer worldwide in 2022 [1] , including 357,200 new cases in China [2] . Among these, HER2-positive breast cancer accounts for approximately 20-25% of all breast cancer cases [3] . This type of tumour cells is characterised by high aggressiveness, high malignancy and rapid progression. Pertuzumab can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, pertuzumab can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Clinical studies have shown that the combination of pertuzumab and trastuzumab exhibits good synergy, significantly improving clinical efficacy and noticeably enhancing patient prognosis [4] . The dual-target therapy combining pertuzumab and trastuzumab has become a cornerstone in the treatment of HER2-positive breast cancer, recommended by guidelines at home and abroad, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines, the Guidelines for Breast Cancer Diagnosis and Treatment by China Anti-cancer Association (CACA). Henlius has been deeply engaged in the anti-HER2 treatment field. Its comprehensive product pipeline includes multiple HER2-targeted drugs that can work synergistically to form effective treatment combinations, thereby benefiting more patients with HER2 tumours. Among them, the company’s self-developed HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac ® in Europe) is a Chinese monoclonal antibody (mAb) biosimilar approved in China, the EU and the U.S. Up to now, it has been approved for marketing in 50 countries and regions and has been licensed out to about 100 countries and regions. The company’s newly-approved small-molecule anti-tumor drug HANNAIJIA (neratinib) has rapidly entered clinical application as a sequential therapy after completion of HANQUYOU, offering a new treatment option for patients with HER2-positive early-stage breast cancer. HLX11 also has the potential to be used in combination with HANQUYOU, further strengthening Henlius’ market position and competitiveness in the HER2 breast cancer treatment field while providing patients with more comprehensive and effective treatment options. The phase 3 international multicenter clinical trial of company’s self-developed innovative anti-HER2 mAb HLX22, has recently completed its first patient dosing in China. It is expected to further improve treatment outcomes for patients with HER2-positive gastric cancer, leading to better survival benefits. Going forward, Henlius will remain dedicated to oncology, continuously enriching and optimising its product pipeline to offer patients a broader range of high-quality, accessible and affordable treatment options. Reference [1] https://www-who-int.libproxy1.nus.edu.sg/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services. [2] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024. [3] Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40. [4] Agus DB, Akita RW, Fox WD, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002; 2: 127–37 SOURCE: Henlius Biotech

Phase 3Drug ApprovalNDAPhase 1Clinical Result

04 Dec 2024

·www.accesswire.com

Alligator Announces First Patient Dosed in Shanghai Henlius Biotech, Inc. Phase 3 Clinical Trial

LUND, SE / ACCESSWIRE / December 04, 2024 / Alligator Bioscience (STO:ATORX)Lund, Sweden, November 27, 2024 - Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that the Company was notified that the first patient has been dosed in a Phase 3 clinical trial with Shanghai Henlius Biotech, Inc. Alligator out-licensed HLX22/AC101 to AbClon, Inc. in October 2016. Abclon, Inc. subsequently sub-licensed AC101 for clinical development by Shanghai Henlius Biotech Inc."We are pleased to announce that Henlius Biotech has dosed the first patient in its Phase 3 international multi-centre clinical trial of HLX22/AC101, aiming to provide a new first-line treatment for HER2-positive advanced gastric/gastroesophageal junction cancer. This progress demonstrates Henlius' commitment to the HLX22/AC101 program. Also, this bodes well for Henlius' completion of the ongoing Phase 2 trial, which will trigger a milestone payment to Alligator," said Søren Bregenholt, CEO of Alligator Bioscience.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected]Phone: +46 (0) 46 540 82 00Johan Giléus, CFOE-mail: [email protected]Phone: +46 (0) 46 540 82 00About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com.AttachmentsAlligator Announces First Patient Dosed in Shanghai Henlius Biotech, Inc. Phase 3 Clinical TrialSOURCE: Alligator Bioscience

Phase 3Phase 2ImmunotherapyClinical Result

30 Oct 2024

·www.prnewswire.com

Fosun Pharma Announces 2024Q3 Financial Results

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyDrug ApprovalPhase 2Phase 3

100 Deals associated with HLX-22

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 positive Gastrooesophageal junction cancer	Phase 3	CN	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	JP	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	GE	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	DE	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	IT	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	PL	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	RO	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	KR	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2 positive Gastrooesophageal junction cancer	Phase 3	ES	Shanghai Henlius Biotech, Inc.	08 Nov 2024
HER2-positive gastric cancer	Phase 3	CN	Shanghai Henlius Biotech, Inc.	01 Nov 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04908813 (ESMO_GI2024) Manual	Phase 2	HER2 positive Gastrooesophageal junction cancer First line HER2-positive	53	HLX22 25 mg/kg + HLX02 + XELOX (Group A)	woyppzhsxa(liiwkcnpdx) = dujdvfinfe soaxneljhy (yodahxhxnl, 6.8 - NE) View more	Positive	27 Jun 2024
				HLX22 15 mg/kg + HLX02 + XELOX (Group B)	woyppzhsxa(liiwkcnpdx) = vlmphqvple soaxneljhy (yodahxhxnl, 9.9 - NE) View more
NCT04908813 (ASCO_GI2024) Manual	Phase 2	HER2 positive Gastrooesophageal junction cancer First line	53	HLX22 25 mg/kg + HLX02 + XELOX	sydombianp(sphuvrirva) = zronegwiyj wmknkpmpgp (pgugyrnalh, 6.8 - NE) View more	Positive	17 Jan 2024
				HLX22 15 mg/kg + HLX02 + XELOX	sydombianp(sphuvrirva) = xozngxjokf wmknkpmpgp (pgugyrnalh, 9.9 - NE) View more
CTR20190723 \| NCT03916094 (NEWS) Manual	Phase 1	Solid tumor her2过表达	-	HLX22	mmqrtfwsjk(qhjctpksyv) = hmqvorpevf rdkkcplsvp (nvuwfdodsh )	Positive	30 Sep 2022

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