Sep 18, 2024｜2024
Latest Results of HANSIZHUANG and HANQUYOU Released at 2024 ESMO
Shanghai, China, September 18, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU were released as poster presentations at the 2024 European Society of Medical Oncology (ESMO) Congress.
HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, and the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC. The product has been approved in China, Indonesia, Cambodia and Thailand. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of MSI-H solid tumours, sqNSCLC, ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting about 80,000 patients. Meanwhile, HANSIZHUANG’s Marketing Authorisation Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA), which is expected to be approved in 2024. Moreover, a wide variety of clinical trials on immuno-oncology combination therapies in differentiated indications has been initiated by the company to further explore the efficacy of the product, such as HANSIZHUANG plus bevacizumab and chemotherapy as first-line treatment for patients with metastatic colorectal cancer (mCRC) , HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC), and HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC), etc.
HANQUYOU is the trastuzumab biosimilar independently developed by Henlius in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. HANQUYOU is indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. Up to date, HANQUYOU has been approved in 48 countries and regions, benefiting 210,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide.
ASTRUM-005
Title
Smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study
Methods
ASTRUM-005 was a randomized, double-blind, placebo-controlled, global, phase 3 trial in patients with extensive-stage SCLC.
Smoking signature analysis
Genomic mutations in 302 patients with available baseline tumor samples were assessed by the Med1CDx panel, which included exon regions of 601 genes. Two bioinformatic methods, the transversion/transition ratio (TTR) method and the Catalogue of Somatic Mutations in Cancer (COSMIC) Signature 4 method, were applied to analyze tobacco-smoking–related signature.
For the TTR method: An R Bioconductor package, Maftools, was used to calculate the fraction of transversion and transition in each sample. TTR value was then defined as the transversion fraction divided by the transition fraction in each sample[2-3]. Specifically, Maftools classified single nucleotide variants (SNVs) into 6 different transition and transversion events (C>A:G>T, C>G:G>C, C>T:G>A, T>A:A>T, T>C:A>G, T>G:A>C). Synonymous SNVs were included in these analyses.
For the Signature 4 method: Mutational signatures were extracted and the contributions of tobacco-smoking–related signatures (Signature 4), annotated by the COSMIC, from the genomic mutation panels of each patient were estimated[4].6 R package “deconstructSigs” was used to calculate the contribution of the mutation[5]. Both methods were validated on targeted panel sequencing from a published NSCLC data set. Both methods were able to distinguish smokers from non-smokers in NSCLC[6].
Statistical analysis
For progression-free survival (PFS) and overall survival (OS), the median was calculated from product-limit (Kaplan–Meier) estimates, while n was the number of patients in each subgroup category. The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using an unstratified Cox proportional hazards model; Efron’s method was used to handle ties. For the analyses of genomic-based smoking signatures, the Wilcoxon test was used to calculate the difference among patients with different smoking histories. The clinical data cutoff date was June 13, 2022.
Results
Baseline characteristics in smoking groups
Patients in the SCLC cohort (N = 302) were grouped based on their smoking history; 23% were current smokers, 55% former smokers, and 22% never smokers. Baseline patient characteristics are summarized in Table 1.
Mutation analysis demonstrated that the most frequently mutated genes were TP53 (90% and 91%), RB1 (68% and 69%), and LRP1B (31% and 28%) in current and former smokers versus never smokers, respectively. Differential analysis on the mutated genes demonstrated that smokers and non-smokers have similar top mutated genes, with never smokers having more mutation in EGFR, DMD, MED12, MTOR, NOTCH1, REL, PGR, DNMT1, GRM3, KMT2A, and CD22.
Smoking signatures in patients with SCLC
No significant differences in smoking signatures were found between groups with different smoking histories using both methods (TTR: P = 0.54; Signature 4: P = 0.38) .
Findings were validated by applying the same analyses on 2 cohorts’ data sets profiled with whole exome sequencing from published studies[1,6]. In 120 samples from 40 patients with SCLC, no correlation between mutation pattern and smoking history in either method was observed (TTR: P = 0.91; Signature 4: P = 0.70)[7].
We observed similar results in another independent data set with whole exome sequencing performed on 110 samples from patients with SCLC (data not shown).10 Patients were further grouped into high/low TTR groups using the median TTR of 1.12 as the cutoff value. The mutation analysis showed that REL was more frequently mutated in non-smokers (P < 0.001) .
Higher TTR resulted in shorter median OS (HR [95% CI], 1.65 [1.05-2.62]; P = 0.03) for patients who only received chemotherapy, while both the high and low TTR groups gained similar benefits for patients who received serplulimab plus chemotherapy (HR [95% CI], 0.97 [0.67-1.4]; P = 0.87) .
Patients in both treatment groups (chemotherapy and serplulimab plus chemotherapy) showed similar benefits in PFS, regardless of the TTR (HR [95% CI], 1.25 [0.83-1.88]; P = 0.29 and 0.95 [0.67-1.34]; P = 0.77, respectively) .
Conclusion
In our ASTRUM-005 study, 67 (22%) patients with SCLC had never smoked. Unlike what was observed with NSCLC, patients with SCLC from our study showed similar tobacco-smoking–related genomic mutation patterns, regardless of their smoking status. Patients with SCLC who have never smoked may develop transversion mutations from other sources unrelated to direct tobacco exposure. Patients with high TTR might gain less benefit from chemotherapy, suggesting mutations in SCLC might be predictive biomarkers for certain therapies.
ASTRUM-004
Title
Exploratory biomarker analysis of phase 3 ASTRUM-004 study: serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer
Methods
Eligible patients were planned to be randomized (2:1) to receive serplulimab or placebo, both in combination with chemotherapy.
Genetic mutations were assessed by the Med1CDx panel in the biomarker evaluable population (BEP). The objective response rate (ORR) was compared between treatment arms and the odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated using a stratified Cochran–Mantel–Haenszel method. Median PFS and OS were estimated using the Kaplan–Meier method. Comparisons between treatment arms were performed, and hazard ratios (HR) and their 95% CIs were estimated by a stratified Cox proportional hazards model.
Results
The clinical data cutoff date was January 31, 2023. A total of 537 eligible patients were enrolled (358 patients in the serplulimab group and 179 patients in the placebo group); 309 patients with detectable samples were included in the BEP.
Baseline characteristics and gene mutation status
Baseline characteristics and efficacy in the BEP were comparable with those in the ITT.
Mutation analysis demonstrated that the most frequently mutated genes were TP53 (85%), LRP1B (34%), and KMT2D (28%), consistent with published data[8-10].
Clinical outcomes by mutation status
In order to identify predictive biomarkers for serplulimab treatment, we analyzed genes and signaling pathways with different mutation frequencies in responders (patients showing complete response or partial response) and non-responders (patients with stable disease or progressive disease) to serplulimab plus chemotherapy treatment. Mutations in the Notch signaling pathway and several other genes were identified. The ORR was consistently higher in patients treated with serplulimab versus placebo, regardless of gene mutation status. A trend of greater ORR was observed in patients treated with serplulimab who had these mutations.
Mutations in the Notch signaling pathway, especially for NOTCH3, were associated with longer median PFS in patients receiving serplulimab versus placebo, possibly due to their roles in the tumor microenvironment in sqNSCLC, which was consistent with previous findings.[11] Mutations in KMT2D, which is involved in the modulation of chromatin structure, and PIK3C2G and EPHA3, which regulate the tumor microenvironment, were associated with better clinical outcomes in the serplulimab arm compared with the placebo arm.
Conclusion
The exploratory biomarker analysis suggests improved clinical benefit with the addition of serplulimab to chemo regardless of genetic mutation status. Furthermore, comparing to those without mutations, patients with mutations in Notch signalling pathway, KMT2D, PIK3C2G, or EPHA3 may derive more clinical benefit when serplulimab was added.
ASTRUM-LC01
Title
Consolidation Serplulimab Following Concurrent Hypofractionated Chemoradiotherapy for Limited-stage SCLC: Preliminary Analysis of Phase II ASTRUM-LC01 Study
Methods
LS-SCLC patients aged between 18-75 years with ECOG performance score of 0-1 were enrolled.
Treatment regimens:
-Chemotherapy: etoposide, 100 mg/m2 d1-3+, cisplatin, 75 mg/m2 d1, or carboplatin, AUC = 5 d1; Q3W, up to 4 cycles
-Hypofractionated radiotherapy: 45Gy/3Gy/15F
-Prophylactic cranial irradiation: 25Gy/2.5Gy/10F
-Consolidation therapy: serplulimab, 300 mg Q3W, until progression or unacceptable toxicity or up to 1 year
The preliminary analysis aimed to evaluate the efficacy of serplulimab consolidation therapy on the objective response rate (ORR), depth of response (DpR), disease control rate (DCR), survival outcomes, and safety profile in LS-SCLC patients.
Results
Patients
Between May 2022 and August 2023, 55 patients were enrolled. The date of data cut-off was April 7, 2024, and the median follow-up duration since initiating serplulimab was 9.8 months. The median cycles of consolidation therapy were 8, and 9 (16.4%) patients had completed the prescribed treatment.
Efficacy
The ORR and DCR following serplulimab treatment were both 96.4% (95% CI 87.5-99.6). The tumor responses were assessed following serplulimab treatment compared with pre-chemoradiotherapy.
Overall, 90.9% of patients achieved a DpR exceeding 50%, and patients achieved sustained tumor remission following serplulimab consolidation therapy.
The median progress-free survival (PFS) was not reached, and 1-year PFS rate was 71.8% (95% CI 60.1-85.8).
Safety
Four patients discontinued the study due to TRAEs. Pneumonitis (5.45%) was the most common grade 3-4 TRAEs. No treatment-related death event was reported.
Conclusion
These results highlight the potential survival benefit and manageable safety of consolidation serplulimab therapy in LS-SCLC.
A Real-world Retrospective Analysis
Title
Efficacy and Safety of Integrating Consolidative Thoracic Radiotherapy with Immunochemotherapy in ES-SCLC: A Real-world Retrospective Analysis
Study Design
This single-center retrospective study analyzed the medical records of patients diagnosed with ES-SCLC at Shandong Cancer Hospital between January 1, 2022 and December 31, 2023. Patients were stratified into three cohorts based on the first-line treatment received: chemoradiotherapy (cohort A), immunochemotherapy (cohort B), and immunochemotherapy followed by cTRT (cohort C). Propensity score matching (PSM) was utilized to adjust for baseline differences. Primary outcomes include real-world PFS (rwPFS) and OS, and secondary outcomes include real-world safety profile.
Results
Of the 374 patients analyzed, cohort C showed significant improvements in rwPFS and OS compared to cohort A. The median rwPFS in cohort C (10.9 months) was longer than cohort A (7.6 months) and B (8.0 months). The 12-month rwPFS rate was highest in cohort C (41%), compared to cohort A (19%) and cohort B (34%). Median OS (mOS) was 14.0 months in cohort A, 20.8 months in cohort B, and not reached in cohort C, with the lower limit of the 95% CI for cohort C being 17.80 months. The 18-month OS rate in cohort C (63%) was numerically higher than both cohort A (28%) and B (62%). After propensity score matching, cohort C still showed improvements in rwPFS and OS. The incidence of grade 3 or higher adverse events was comparable across cohorts, with myelosuppression being the most common. However, the incidence of grade 3 or higher pneumonitis was notably higher in cohorts B and C, aligning with previous reports.
Conclusion
Over half of the patients in the immunotherapy cohorts (B and C) received serplulimab (an anti-PD-1 monoclonal antibody). The combination of cTRT with immunochemotherapy for ES-SCLC showed improved rwPFS and OS, and the overall safety profile remained manageable. These findings highlight the need for further prospective studies to confirm the optimal integration of cTRT in ES-SCLC treatment strategies.
An Open-label, Single-arm, Phase 2 Trial
Title
Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: an open-label, single-arm, phase 2 trial
Study Design
This open-label, single-arm, phase 2 trial was conducted to evaluate the efficacy of perioperative serplulimab in patients with resectable squamous NSCLC.
The inclusion criteria were:
-Age: between 18 and 75 years
-Surgically resectable stage II-IIIA squamous NSCLC.
Patients were given intravenous serplulimab (300mg) in combination with (nab—) paclitaxel and carboplatin in 21-day cycles. Neoadjuvant therapy consisted of 2-3 cycles, while adjuvant therapy comprised 1-2 cycles, for a total of 4 cycles.
The primary endpoint of this study was the major pathological response (MPR), defined as 10% or less viable tumor cells in the resected specimen.
The secondary endpoint was pathological complete response (pCR), defined as the absence of viable tumour cells in the resected specimen.
Results
A total of 30 patients were enrolled. Among them, 16 (53.3%) patients had stage IIIA disease. Surgical resection was performed in 29 (97%) patients, with R0 resection achieved in 28 (93.3%) patients.
MPR was observed in 23 (76.7%, 95%CI: 57.3-89.4%) patients, and pathological complete response (pCR) occurred in 15 (50%, 95%CI: 31.7-68.3%) patients.
Of the 30 patients, 2(6.67%) achieved CR, 20 (66.67%) achieved PR, 8(26.67%) achieved SD, and the ORR was 73.33%.
Neutropenia was the most prevalent grade 3-4 adverse events (13 [43%] of 30 patients).
The clearance of circulating tumor DNA following neoadjuvant treatment was found to be a significant predictor of pCR (P=0.007), with a sensitivity of 78.6% and specificity of 76.9%.
Conclusion
The exploratory biomarker analysis suggests improved clinical benefit with the addition of serplulimab to chemo regardless of genetic mutation status. Furthermore, comparing to those without mutations, patients with mutations in Notch signalling pathway, KMT2D, PIK3C2G, or EPHA3 may derive more clinical benefit when serplulimab was added.
Neoadjuvant Treatment in HER2-positive, Stage II-III Breast Cancer
Title
Phase II study of pyrotinib plus albumin-bound paclitaxel and Trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer
Methods
Patients with previously untreated non-metastatic HER2-positive BC were assigned to receive six neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus HLX02 (8 mg/kg loading dose, followed by 6 mg/kg) and Nab-P (260 mg/m2) q3w. The primary endpoint was pCR (ypT0/isN0). CTCs was captured and counted at baseline (P0), after neoadjuvant therapy (P1), and after surgery (P2) using Metafer-SE-iFish, and analyzed using Imaris 10.1 following image acquisition with the BZ-X800 microscope.
Results
From December 2020 to August 2023, a total of 214 patients were enrolled and completed neoadjuvant therapy and surgery. The pCR rate was 62.96% (95% CI, 55.65% -69.86%, p=. 001). The most common grade 3-4 adverse events were diarrhea (34.7%) and neutropenia (6.5%). Of 95 patients who underwent CTCs analysis, 63 (66.3%) achieved pCR. CTCs count was significantly reduced at P1 compared to that of at P0 (3.06±3.38 vs.0.84±1.53 FU/5ml, p<.001). Patients with pCR have larger nuclei size at P0 (95% CI, 1.02-1.38; P =. 04), less count (95% CI, 1.49-8.28; P =. 03) and lower membrane intensity (95% CI,0.93-0.98; P =. 03) at P1 to those with non-pCR (Table).
Conclusion
In women with HER2-positive, stage II-III BC, the neoadjuvant regimen pyrotinib plus Nab-P and HLX02 effectively promoted pCR of tumor and presented an acceptable tolerability. Personalized monitoring of CTCs during neoadjuvant therapy of early BC may aid in real-time assessment of treatment response and help predict pCR.
Reference
1. Rizvi H, et al. J Clin Oncol. 2018;36:1645.
2. Song K, et al. Transl Lung Cancer Res. 2018;7:439-449.
3. Mayakonda A, et al. Genome Res. 2018;28:1747-1756.
4. Alexandrov LB, et al. Nature. 2013;500:415-421.
5. Rosenthal R, et al. Genome Biol. 2016;17:31.
6.Zhou H, et al. Nat Commun. 2021;12:5431.
7.George J, et al. Nature. 2015;524:47-53.
8. Xu F, et al. Onomatology. 2020;9:1731943.
9. Yu J, et al. Cancers. 2022;14:3382.
10. Pan Y, et al. Cancer Cell. 2023;41:88-105.
11. Zhou C, et al. J Thorac Oncol. 2023;18:93-105.
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Privacy Policy
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Privacy Policy
Introduction
Shanghai Henlius Biotech, Inc., and, where applicable, its affiliates and subsidiaries (collectively, “we” , “us” or “our”) attach great importance to the protection of your privacy and personal information. This Privacy Notice (this “Policy”) is formulated in accordance with applicable PRC laws and regulations governing the protection of personal information in the People’s Republic of China (“PRC”).
This Policy applies when: (1) you browse or use our website and other online resources (such as our WeChat official accounts); (2) subscribe to our news or announcements; or (3) contact us through the contact details or other interactive features made available on our website, or otherwise interact with us through our website.. The purpose of this Policy is to explain how and why we process your personal information, the types of personal information involved, applicable retention periods, your rights, and the measures we take to protect personal information. Please read this Policy carefully to ensure that you fully understand its content.
In certain business scenarios, we may provide additional explanations regarding the processing of your personal information through separate agreements, privacy statements, or personal information notices. In the event of any inconsistency, such documents shall prevail. For example, where a recruitment function is provided through a third-party platform or service, the relevant third party privacy policy or notice may also apply.
For the purposes of this Policy, “personal information” refers to all kinds of information related to identified or identifiable natural persons, excluding anonymized information.
We collect, use, store, transfer and otherwise process personal information in strict compliance with applicable PRC laws and regulations of the People’s Republic of China.
Our website may contain links to third party websites for your convenience. We do not control, and are not responsible for, the privacy practices of such third parties. We encourage you to review their privacy policies before using those websites.
If you have any questions or concerns regarding this Policy or our processing of personal information, please contact us using the details provided below.
This Policy will help you understand:
I. How we collect your personal information
II. How we use your personal information
III. How we entrust, share, transfer and publicly disclose your personal information
IV. Cross border transfer of personal information
V. How we store your personal information
VI. Security measures
VII. Your rights
VIII. Personal information of minors
IX. Updates to this Policy
X. How to contact us
I. How do we collect your personal information?
In addition to our employees, we may process personal information of the following persons:
• Visitors and users of our website;
• Healthcare Professionals;
• Investigators of clinical trial institutions and personnel of contract research organizations in clinical trials;
• Subjects of clinical trials and their relatives;
• Consumers/patients and their relatives using our products or services;
• Staff of business partners (including vendors, distributors, partners, etc.); and
• Our applicants.
We may process personal information of website visitors and individuals who contact or interact with us through our website or other online resources. Depending on the relevant page, function, or interaction, separate privacy notices, consents, platform privacy policies, contracts, or other notices may apply.
Based on the context in which you interact with us, we may collect personal information by the following means and on the legal bases permitted by applicable PRC laws and regulations, including your consent, the necessity for entering into or performing a contract, compliance with legal obligations, protection of life, health or property, public health needs, or other circumstances permitted by law:
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When you visit our website, most of our services do not require any registration, and you can visit our website without telling us who you are. However, some pages or functions may require you to provide certain personal information. If you choose not provide such information as we request, you may not be able to access certain content or functions or we may not be able to respond to your inquiry, request or subscription. Please refer to the relevant page or notice for further details about the categories of personal information collected in a specific scenario.
• Personal information we collect from vendors or business partners
In the course of our daily business operations, we may collect personal information from our vendors or business partners. We require our vendors and business partners to comply with the requirements of the personal information protection laws and regulations of the PRC and to lawfully provide us with personal information. If you are an employee or representative of one of our vendors or business partners, we may collect personal information such as your name and contact details for the purpose of establishing business contacts and cooperations.
• Personal information we collect from publicly available sources
We may collect personal information of medical and healthcare professionals from such publicy available sources, such as the official websites of medical institutions and the official websites of competent government departments, and process such information within a reasonable scope and for lawful purposes. For example, for the purpose of lawful academic or professional interaction with healthcare professionals, we may collect the name, gender, employer, position, practitioner registration information, academic title, degree, educational background, specialty expertise, and profile information, where such information has been lawfully made public.
Our website may include links, contact details, QR codes, or references to third-party platforms or services. Where you choose to interact with us through such third-party platforms or services, the relevant third party may also process your personal information in accordance with its own privacy policy and applicable law, and we encourage you to review such policy before submitting your information.
II. How do we use your personal information?
We may use your personal information for the following purposes:
• Operating, maintaining and improving our website and other online resource;
• Researching, developing, providing and continuously improving our products and services;
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• Academic interaction with healthcare professionals;
• Responding to your inquiries, requests, or communications sent through our website or the contact details made available on our website;
• Providing subscription services for our news, announcements, or investor-related updates;
• Managing and maintaining our relationship and communications with business contacts who reach us through our website;
• Recruiting and human resource management;
• Internal compliance management，audit，record-keeping; and
• Complying with applicable PRC laws and regulations, for example, monitoring and reporting adverse events for purposes of performing drug quality management responsibilities, providing medical information and dealing with product complaints, etc..
We will process personal information only to the extent necessary for the relevant purpose. Where required by applicable law, we will obtain your consent or separate consent before processing your personal information or sensitive personal information. Where a third-party platform or service is used in connection with a particular function, the relevant third party may process your personal information in accordance with its own privacy policy and applicable law.
III. How do we entrust, share, transfer and publicly disclose your personal information?
1. Entrustment
We may entrust our business partners with the processing of your personal information for the purpose(s) described in this Policy. We will enter into appropriate confidentiality, data processing and security agreements with such entrusted parties and require them to process personal information in accordance with our instructions , this Policy and applicable PRC laws and regulations.
2. Sharing and public disclosure
For the purpose(s) described in this Policy, we will share or publicly disclose your personal information only where permitted by applicable PRC laws and regulations and, where required, after obtaining your consent or separate consent. Such circumstances may include:
• Sharing your personal information among our affiliates and subsidiaries where necessary for legitimate business, management, compliance, or operational purposes;
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• Disclosing your personal information to the extent that it is permitted or required by applicable PRC laws and regulations or for the purpose of assisting with investigations by judicial, regulatory or law enforcement authorities.
• other circumstances permitted by applicable PRC laws and regulations.
If you submit your information through or in connection with a third-party platform or service referred to on our website, the relevant third party may independently process your personal information in accordance with its own privacy policy and applicable law.
3. Transfer
We will not transfer your personal information to any other company, entity or individual unless otherwise permitted by applicable law and, where required, after obtaining your consent. Further, in the event of a merger, acquisition, insolvency, reorganization, division, dissolution, bankruptcy, or similar transaction, we will require the new processor of your personal information to continue to be bound by this Policy or we will require the new processor to obtain your consent again.
IV.How do we provide your personal information across borders?
In principle, personal information that we collect and generate in the course of our operations within the territory of the PRC will be stored within the PRC. In certain circumstances, it may be necessary for us to provide your personal information to recipients outside the PRC in connection with our business operations, website functions, or communications, where permitted by applicable PRC laws and regulations. As required by applicable laws and regulations regarding the protection of personal information, we will provide you with the required notice and obtain your separate consent before providing your personal information across any border, unless otherwise permitted by law. We will use lawful cross-border transfer mechanisms to transfer your personal information oversea and will take necessary measures to ensure that the oversea recipients provide a level of protection required by applicable PRC laws and regulations.
You may obtain more information about cross-border transfers of personal information and oversea recipients through the contact methods referred to in this Policy.
V. How do we store your personal information?
We will retain your personal information for the minimum period necessary to achieve the purposes described in this Policy ,unless a longer retention period is required or permitted by applicable PRC laws and regulations. Upon expiration of the applicable retention period, we will promptly delete or anonymize your personal information in accordance with applicable PRC laws and regulations. Our criteria for determining the period for which personal information shall be retained include:
• Applicable laws, regulations and other relevant requirements;
• The period of time needed for us to provide services, maintain business relations or interact with you; and
• The period of time needed for us to perform relevant agreements or fulfil the purposes described in this Policy.
VI. What security measures do we take to protect your personal information?
In accordance with applicable PRC laws, regulations, and the requirements of relevant national standards, we take reasonable and appropriate security and precautionary measures to protect the personal information we process against unauthorized access, public disclosure, use, modification, destruction or loss of data. However, you are also responsible for taking appropriate measures to protect the security of the devices, systems, and networks you use when accessing our website or communicating with us.
VII. Your rights
In accordance with the requirements of the applicable PRC laws and regulations, you may have the following rights in respect of your personal information:
• To know about and make decisions regarding the processing of your personal information;
• To access or copy your personal information;
• To correct or supplement your personal information;
• To delete your personal information;
• To request for explanation of rules regarding processing of personal information; and
• To change the scope of your consent or revoke your consent , where processing is based on your consent.
If you wish to exercise your rights with respect to personal information, you may contact us through the contact information listed in this Policy and we will respond to any request in accordance with applicable relevant laws and regulations. When you exercise the above rights, we may verify your identity to safeguard the security of your personal information. Subject to applicable PRC laws and regulations, there may be circumstances where we are unable to respond to all or part of your request.
VIII. How do we process the personal information of minors?
For the purposes of this Policy and in accordance with applicable PRC laws and regulations, our products, websites and services are not targeted at minors under the age of 14. Minors under the age of 14 should not provide personal information to us without the consent of a parent or legal guardian.
If a minor's personal information is collected with the consent of a parent or legal guardian, we will process the information only when permitted by law, with the express consent of the parent or legal guardian, or necessary for the protection of the minor. If we discover that we have collected personal information without obtaining verifiable prior consent of a parent or legal guardian, we will seek to delete the data as soon as possible.
IX. Updates of the Policy
We may revise our Privacy Policy from time to time. We will post the updated version on our website and update the “Last Updated” date above or below this Policy.
Last updated: March 30, 2026.
X. How to contact us?
If you have any questions, comments or suggestions concerning this Policy, or any questions or concerns about our processing of your personal information, you may contact us in the following ways:
Address: 11/F, B8 Building, No.188 Yizhou Rd, Xuhui District, Shanghai
Tel.: 021- 33395800
Postal Code: 200233
Email: [email protected]
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Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.
We strive to ensure that the content on our website can be accessed and used by individuals with diverse needs, including those who rely on assistive technologies. As our website continues to evolve, we recognize that accessibility is an ongoing effort, and we are continuously working to improve usability and accessibility across our digital platforms.
If you experience difficulty accessing any part of our website, or have suggestions on how we can enhance accessibility, we welcome your feedback. To help us respond effectively, please include the specific webpage address (URL) and a brief description of the issue encountered.
Contact us:
Email: [email protected]
(Please include “Website Accessibility” in the subject line)
Henlius will make reasonable efforts to review accessibility-related feedback and improve the overall online experience for all users. While we strive to improve accessibility, we do not guarantee that every page or feature will be fully accessible to every user in all circumstances.
Terms of Use
This website (http:/) is developed and operated by Shanghai Henlius Biotech, Inc. (“Henlius”). Please read these Terms of Use carefully before accessing or using this website. By accessing, browsing or using this website, you acknowledge that you have read, understood and agreed to be bound by these Terms of Use and applicable PRC laws and regulations.
Henlius reserves the right to modify or update these Terms of Use at any time. Any updated version will be posted on this website with a revised “Last Updated” date. Please review them periodically for updates.
Prohibited Conduct:
You shall not infringe the lawful rights and interests of Henlius or any third party, nor interfere with or attempt to interfere with the normal operation, security, or integrity of this website by any means. Without limitation, you shall not use this website for any unlawful purpose, attempt unauthorized access to any part of the website or related systems, introduce malicious code, scrape or extract website content through automated means, or otherwise interfere with the website’s operation or security features.
Copyright
All content on this website, including but not limited to text, data, logos, graphics, audio, video and other materials, is owned by Henlius or its respective rights holders, unless otherwise stated. Such content is protected by applicable Chinese and international copyright laws. This website and its content may be accessed and used only for lawful, personal, and non-commercial purposes. Without prior written consent, no entity or individual may copy, reproduce, republish, upload, post, transmit, distribute, modify, create derivative works from, mirror, or otherwise use such content for commercial or public purposes.
Disclaimers
To the fullest extent permitted by applicable PRC laws and regulations, Henlius makes no warranties or representations, express or implied, regarding the content of this website, including but not limited to accuracy, completeness, timeliness or suitability for any particular purpose. Henlius does not undertake any obligation to update the content of this website , except as otherwise required by applicable PRC laws and regulations.
You use this website and any information obtained from it at your own risk. To the fullest extent permitted by applicable PRC laws and regulations, Henlius shall not be liable for any loss or damage arising from the use or inability to use this website, including but not limited to system failures, computer viruses or data loss.
Medical Information
Nothing on this website constitutes medical advice, diagnosisor treatment recommendations. Medical decisions should always be made in consultation with qualified healthcare professionals. Any product-related or disease-related information provided on this website is provided for general informational purposes only and should not be construed as medical advice, diagnosis, or treatment recommendations; any product information is subject to the approved prescribing information and applicable local laws and regulations.
Third Party Websites
This website may contain links to third party websites for convenience. Henlius is not responsible for the content, availability, privacy practices, terms or use of such third-party websites. Access to third party websites is at your own risk.
Privacy
Henlius respects your privacy. Please refer to our Privacy Notice for details.
Governing Law
These Terms of Use shall be governed by the laws of the People’s Republic of China.
Last updated: March 30, 2026