Jun 01, 2025｜2025
Latest Results of Serplulimab in Lung and Gastrointestinal Cancer Released at ASCO 2025
Shanghai, China, June 1, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results from over ten studies on lung and gastrointestinal cancer of Henlius’ self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. HANSIZHUANG is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in over 30 countries and regions including China, Europe and Southeast Asia.
Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,900 subjects enrolled in China, the U.S., Japan, Turkey, Poland, Georgia and other countries and regions.
Covering first-line treatment of lung cancer, SCLC long-term follow-up confirming survival benefits
As for serplulimab, Henlius covers the full range of first-line treatment of lung cancer. In addition to approved indications for sqNSCLC, ES-SCLC and nsNSCLC, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). At this conference, several research studies in the field of lung cancer were selected for poster presentations. These include the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC led by Professor Ying Cheng from Jilin Cancer Hospital, with the results from the final analysis and 42.4 months of median follow-up data, as well as the first publication of the four-year OS data. Additionally, updated data from a phase 2 study of HLX07 plus serplulimab as first-line treatment for sqNSCLC led by Professor Yi-Long Wu from Guangdong Provincial People’s Hospital was released.
Title: Serplulimab versus placebo plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: efficacy and safety from the end-of-study analysis of the international phase 3 ASTRUM-005 study
Results: Between Sep 12, 2019 and Apr 27, 2021, 585 patients were randomized (serplulimab group, n = 389; placebo group, n = 196) and received either 4.5 mg/kg of serplulimab (serplulimab group) or placebo plus chemo. All 585 patients received at least one dose of study treatment and were included in efficacy and safety analyses. As of data cutoff on May 7, 2024, OS events occurred in 280 (72.0%) patients in the serplulimab arm and 166 (84.7%) in the placebo arm. Consistent with previous reports, marked improvement in OS, PFS, ORR, and DOR were achieved by patients receiving serplulimab plus chemo than those receiving placebo plus chemo. Median OS was 15.8 vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) for respective arms; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). Median PFS according to independent radiology review committee (IRRC) assessment per RECIST v1.1 was 5.8 vs 4.3 months (stratified HR 0.47, 95% CI 0.38–0.57), respectively. Subgroup analysis of OS by age, sex, race, ethnicity, ECOG PS, smoking history, brain metastasis, or PD-L1 expression level revealed similar trends of improvement in the serplulimab arm across subgroups. The safety profile was consistent with previous findings. Serplulimab/placebo-related treatment-emergent adverse events of grade 3 or higher occurred in 136 (35.0%) and 57 (29.1%) patients in respective arms. No new safety signals were identified in this study.
Conclusion: This end-of-study analysis showed that addition of serplulimab to chemo continued to confer survival benefit to previously untreated patients with ES-SCLC along with manageable safety. These results support serplulimab plus chemo for first-line treatment of ES-SCLC.
Title: A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced or recurrent squamous non-small cell lung cancer
Results: As of 31 December 2024, 27 patients were enrolled and randomly assigned to group A (n=13) and group B (n=14) in part 3. Two groups of patients received HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy. 15 (55.6%) patients had metastatic disease. With a median follow-up of 16.0 months, IRRC-assessed confirmed ORR per RECIST 1.1 was 69.2% (95% CI 38.6–90.9) in group A and 71.4% (95% CI 41.9–91.6) in group B. Disease control rate was 92.3% (95% CI 64.0–99.8), and 100% (95% CI 76.8–100.0), respectively. Median PFS was 15.1 (95% CI 4.1–not available) months in group A and not reached in group B. The median overall survival and duration of response were not reached in either group as of the data cutoff date. All the patients in both groups reported treatment-emergent adverse events (TEAEs).
Conclusion: First-line HLX07 plus serplulimab and chemotherapy showed encouraging preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation.
IIT/Real-world studies validating therapeutic potential for gastrointestinal tumours
In the field of gastrointestinal cancers, the company continues to deepen its clinical exploration of serplulimab. In addition to the approved indication for ESCC, the company is actively advancing a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the international multi-centre phase 3 clinical trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC). Besides, the latest data on 12 IIT/real-world studies of serplulimab in gastrointestinal tumours were also presented at the congress, covering gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, rectal cancer and nasopharyngeal carcinoma.
Title: Safety, efficacy and biomarker analysis from a phase II trial of intensive chemotherapy combined with serplulimab, trastuzumab in patients with advanced HER2-positive gastric cancer
Results: From July 2022 to September 2024, 40 patients with unresectable locally advanced or metastatic HER2-positive gastric cancer were recruited to receive serplulimab, trastuzumab and the DOS regimen. The median follow-up was 7.9 months. There were 10 females and 30 males, with a median age of 59 (31-74). 37 patients were eligible for efficacy assessment. The objective response rate (ORR) was 92% (95% CI: 0.87, 0.96). Median progression free survival has not been reached. 38 patients (95%) experienced adverse events (AEs) of any grade. Grade 3 or above AEs occurred in 14 patients (35%), 2 patients with grade 4 AEs (1 with thrombocytopenia and 1 with myelosuppression). No grade 5 events were observed. The most common AEs were anemia (35%), neutropenia (23%), nausea and vomiting (20%) and leukopenia (20%). 15 (38%) patients had dose interruptions due to AEs, with no treatment discontinuation.
Conclusion: This regimen demonstrated remarkable efficacy with a high ORR and manageable toxicity. Tumor HER2 CNV and ctDNA dynamic monitoring correlated with treatment efficacy.
Title: Efficacy and safety of second-line therapy with serplulimab, lenvatinib, and paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) for whom immunochemotherapy failed: A multicenter, single-arm, phase II trial (STILL).
Results: 47 second-line gastric cancer patients for whom immunochemotherapy failed from 8 centers were enrolled to use serplulimab combined with lenvatinib. Patients with CPS ≥1 and ≥5 account to 55.3% (26/47) and 29.8% (14/47). Median follow-up duration was 6.3 months. Among the 41 patients who had underwent at least one assessment, the ORR was 51.2% (21/41, 95% CI: 35.1%-67.1%). The mPFS was 7.1 months (95% CI: 6.1-NA) and the median OS (mOS) was 13.7 months (95% CI: 11.6-NA). The overall incidence of adverse events (AEs) was 72.3%, with 17.0% of patients had grade 3-4 treatment-related AEs. The most common AEs were leukopenia, neutropenia, and numbness.
Conclusion: Continual immunotherapy with serplulimab, combined with lenvatinib and paclitaxel, demonstrated promising efficacy and manageable safety in patients with GC/GEJC. This regimen represents a potential new treatment option for patients who have failed first-line immunochemotherapy.
Title: Continuation of serplulimab-based therapy beyond first progression in advanced gastric/gastroesophageal junction (G/GEJ) cancer: Preliminary results from the SCAFIGC trial
Results: As of November 2024, 53 first-line patients with advanced G/GEJ cancer patients were enrolled, with a median age of 62 years, and 32 patients (60.38%) were aged ≥60 years. Among the 46 patients evaluable for tumor response, the ORR was 52.17% (95% CI: 36.95%-67.11%), with 3 patients achieving complete response (CR), and the disease control rate (DCR) was 82.61% (95% CI: 68.58%-92.18%). The median PFS was 13.73 months (95% CI: 6.43-not reached), with a 12-month PFS rate of 51.57% (95% CI: 36.22%-73.43%), and four patients had PFS of more than one year at the data cut-off date. Median DOR and OS were not yet mature. Patients tolerated treatment well, with grade ≥3 treatment-related adverse events (TRAEs) reported in 5 patients (9.43%), the most common being decreased neutrophil count (3.77%).
Conclusion: Patients with advanced G/GEJ cancer demonstrate promising clinical efficacy and manageable safety after receiving first-line serplulimab combined with chemotherapy.
Title: Efficacy and safety of anti-PD-1 combined with thymosin and SOX in neoadjuvant treatment of cStage III gastric or esophagogastric junctional adenocarcinoma (NAPTSOX24): A prospective, open-label, single-arm, phase II clinical study.
Results: 30 patients with locally advanced gastric cancer were enrolled to receive 3 cycles of serplulimab, thymosin α1 and SOX regimen. Radical gastrectomy plus D2 lymphadenectomy were performed 2–6 weeks post-treatment. Median age of all the 30 cases was 66 years, 90% (27/30) were male, and 46.7% (14/30) had EGJ tumors. Till now, 53.3% (16/30) patients have undergone curative gastrectomy, with 25.0% (4/16) achieving pCR and 37.5% (6/16) demonstrating MPR. Patients with intestinal Lauren type exhibited a significantly better drug response. The variation in CD3+ T cell count was significantly higher in patients with pCR/MPR (P=0.036), suggesting a better predictive value for pathological responses than PD-L1 expression and microsatellite instability status. TRAEs were reported in 66.7% (20/30) cases, with diarrhea (46.7%, 14/30) being the most frequent. No grade 5 TRAEs occurred. Immune-related adverse events were only reported in 10% (3/30) cases.
Conclusion: Combination of anti-PD-1, thymosin α1, and SOX regimen promising efficacy with manageable toxicity in the neoadjuvant setting of locally advanced G/EGJ cancer, independent of PD-L1 expression. Ongoing follow-up will further assess its clinical benefits and safety. (ClinicalTrials.gov identifier: NCT06461910).
Title: Efficacy and safety of serplulimab-based therapy in HER2-negative advanced gastric cancer: A real-world study
Results: 49 patients (49/71, 69.0%) received first-line serplulimab-based therapy, and 22 (22/71, 31.0%) treated in the later lines were included in this analysis. The median age was 65 years (range 35-80) and 71.8% (n=51) were males. The majority received a combination of chemotherapy (n=56, 78.9%), with taxanes+platinum-based (n=30, 42.3%) regimen being the most common, followed by fluorouracil+taxanes-based (n=15, 21.1%), fluorouracil+platinum-based (n=8, 11.3%), and fluorouracil+taxanes+platinum-based (n=3, 4.2%) regimen. The ORR and DCR were 47.2% (95% CI: 33.3-61.4) and 90.6% (95% CI: 79.3-96.9), respectively. As of December 23, 2024, the median follow-up duration was 8.4 months. The median rwPFS of all patients was 10.6 months (95% CI: 7.2-NR), 15.9 months (95% CI: 8.0-NR) for patients who received taxanes+platinum-based regimen, and 23.7 months (95% CI: 23.7-NR) for patients treated with fluorouracil+taxanes-based regimen. Median OS was not reached; the first-line serplulimab treatment showed a superior 1-year OS rate than in later lines (93.8% vs. 49.6%), and patients treated with the fluorouracil+taxanes-based therapy achieved a higher 1-year OS rate than taxanes+platinum-based regimen (100.0% vs. 81.3%). The median DoR was 8.5 months (95% CI: 4.3-NR). A total of 30 patients (42.3%) reported any grade AEs; 12 (16.9%) experienced grade 3-4 AEs, and myelosuppression (n=6, 10.9%) was the most common.
Conclusion: Our real-world study demonstrated that serplulimab-based therapy has a favorable efficacy and acceptable toxicity in HER2-negative advanced gastric cancer patients, and long-term follow-up is needed.
Title: Phase ll trial of anti PD-1 monoclonal antibody and FOLFOXIRI combined with long-course radiotherapy as the total neoadjuvant treatment for proficient mismatch repair, locally advanced, low rectal cancer(PANFORTE)
Results: As of June 2024, 22 patients with pMMR locally advanced low rectal cancer were enrolled to receive FOLFOXIRI plus serplulimab in combination with long-course radiotherapy as the total neoadjuvant treatment, with a median age of 59 years and a median DAV of 4 cm. 86.3% (19/22) patients completed the full TNT regimen. Among the 20 patients eligible for endpoint assessments, the overall CR rate was 75% (15/20), and the sphincter preservation rate was 95% (19/20). 11 (55%) patients achieving cCR opted for a watch-and-wait approach, whereas 9 patients underwent radical surgery. 20% (4/20) achieved pCR and 25% (5/20) had a tumor regression grade (TRG) of 2. The most common severe toxicity was neutropenia (grade 3, 27.3% [6/22]. The scRNA sequencing indicated that non-CR patients exhibited lower T cell infiltration and weaker MHC-I/II signaling.
Conclusion: TNT regimen significantly enhances CR rates and anal preservation in pMMR LALRC compared to historical benchmarks, with an acceptable safety profile. May be an alternative treatment option for LALRC patients who strongly desire anal preservation.
Title: Real-world effectiveness and safety of first-line serplulimab in patients with metastatic or locally advanced esophageal carcinoma
Results: A total of 104 patients were included, with a mean age of 68 years (81 [77.9%] male). Histological subtypes comprised ESCC (80.8%), combined small cell and adenocarcinoma (9.6%), mixed neuroendocrine–non-neuroendocrine neoplasms (5.8%), and neuroendocrine neoplasm (3.8%). Of these, 97 patients (93.3%) received concurrent chemotherapy, 10 (9.6%) underwent targeted therapy, and 21 (20.2%) received radiotherapy. Among 90 evaluable patients, the ORR was 40.0% (95% CI: 29.8–50.9), while the DCR was 97.8% (95% CI: 92.2–99.7). After a median follow-up of 6.8 months (range: 0.6–25.4), the median rwPFS was 12.0 months (95% CI: 8.9–NE), and the median rwOS was not reached (95% CI: 13.3–NE). The estimated 12-month survival rate was 73.5% (95% CI: 60.4–89.3). Overall, 55.8% of patients (n=58) experienced AEs, 18.3% (n=19) reported treatment-related adverse events (TRAEs), and 1.9% (n=2) experienced serious adverse events (SAEs), including hyperkalemia and leukopenia.
Conclusion: This real-world study supports the efficacy of serplulimab as a first-line treatment for metastatic or locally advanced EC, encompassing a wide range of histological subtypes and diverse patient populations. The observed outcomes align with those from randomized controlled trials. The safety profile was consistent with previous findings, with no new safety concerns identified.
Title: Preoperative treatment for potentially resectable esophageal cancer: Insights from a nationwide real-world study
Results: As of December 2023, a total of 95 EC patients who received serplulimab-based neoadjuvant therapy followed by radical surgery were included. The majority were male (n = 86, 90.53%), with a median age of 63 years. SCC accounted for 93 cases (97.89%) of the primary tumors, with most located in the middle thoracic esophagus (n = 68, 71.58%). Patients generally presented with heavy tumor burden, with 88 patients (92.63%) at stage T3/4 and 90 patients (94.74%) with positive lymph nodes. 89 underwent R0 resection, resulting in an R0 rate of 93.68%. The pCR rate was 23.16%, and the MPR rate was 41.05%. Tumor and nodal downstaging rates were 56.84% and 61.05%, respectively. Logistic regression showed that PD-L1-positive patients had significantly higher odds of achieving pCR (OR = 12.73, P = 0.016) and MPR (OR = 2.95, P = 0.031). The overall AE incidence was 96.84%, with 28.42% experiencing grade ≥3 AEs. The most common grade ≥3 AE was pneumonia, which occurred in 22.11% of patients. No new safety signals were identified, and patients generally tolerated the treatment well.
Conclusion: This study represents the large-scale nationwide real-world investigation of serplulimab-based neoadjuvant therapy for esophageal cancer. The findings highlight the potential of serplulimab-based neoadjuvant therapy with manageable toxicity.
Title: A prospective, observational Phase II clinical study evaluating hepatic artery infusion chemotherapy in combination with HLX10 and HLX04 as first-line treatment for patients with advanced hepatocellular carcinoma
Results: As of September 2024, a total of 35 eligible patients were enrolled in the study to receive hepatic artery infusion chemotherapy in combination with HLX10 and HLX04. 28 (80.0%) patients had received at least 3 cycles of treatment. Of the 35 patients, 32 underwent at least one assessment of treatment response, with the best outcomes as follows: 17 (53.1%) achieved partial remission (PR), and 12 (40.0%) had stable disease (SD). The ORR and DCR were 53.1% and 90.6%, respectively. Notably, among patients who had received at least 3 cycles of treatment, 17 patients achieved PR, resulting in an ORR of 63.0%. Moreover, 5 patients underwent successful hepatectomy after at least 3 cycles of treatment, and postoperative pathological evaluation revealed extensive tumor necrosis in the excised tissues. The median follow-up duration was 8.4 months, during which 6 (18.8%) patients experienced disease progression, yielding a one-year PFS rate of 70.5% (95% CI: 47.0%–85.0%). In terms of safety, 17 patients (48.6%) experienced at least one grade 3 or 4 adverse event (AE), with the most frequent being decreased lymphocyte count (20%).
Conclusion: The combination of HLX10, HLX04, and HAIC as first-line treatment for advanced HCC has demonstrated promising efficacy, particularly in patients completing three or more cycles. The safety profile of this combination therapy was acceptable, with manageable AEs. Further investigation in larger trials is warranted.
Title: Phase II trial of serplulimab combined with gemcitabine plus nab-paclitaxel (GnP) and SBRT for metastatic pancreatic cancer as the first-line treatment
Results: As of January 2025, 47 patients with metastatic pancreatic cancer were enrolled to receive to serplulimab and GnP plus SBRT (SGSBRT) as the first-line treatment. 41 patients have been followed for more than 6 months, with all 47 patients achieving efficacy according to the protocol. The 6-month PFS rate was 78.48%. The ORR was 74.47% (35/47), including 1 complete response (CR) and 34 partial responses (PR), and the DCR was 100%, with 12 stable disease (SD). The median PFS was 8.6 months, and the median OS was 15.5 months. The frequent grade 3 drug-related AEs were neutropenia (20/47, 42.55%), leukopenia (19/47, 40.43%), anorexia (18/47, 38.30%), and fatigue (11/47, 23.40%). The correlation between biomarkers and efficacy and prognosis are under-analyzed.
Conclusion: This phase II study has met our preset primary endpoint with 78.48% in 6-month PFS rate, and SGSBRT presented promising efficacy with manageable safety profile and expected antitumor activity. This combination might be a promising option as first-line therapy for Chinese patients with mPDAC.
Title: First-line serplulimab and bevacizumab combined with nab-paclitaxel/gemcitabine followed by mFOLFOX in advanced pancreatic cancer: A phase II trial
Results: 37 patients with advanced pancreatic cancer were enrolled to receive first-line serplulimab and HLX04 (a bevacizumab biosimilar) combined with nab-paclitaxel plus gemcitabine (nab-P/Gem), followed by modified FOLFOX. The average age of the patients was 62 years, and 22 of them (59.5%) were male. Distant organ metastases were present in 34 patients (91.9%), with the liver being the most common site (n=26, 70.3%). The confirmed ORR was 67.6% (95% CI, 49.5-82.6), including 1 patient with a complete response (CR), meeting the primary endpoint. Only 1 patient had progressive disease (PD) as the best response, yielding a DCR of 97.1% (95% CI, 84.7-99.9). the median follow-up was 6.1 months. At the 6.1-month follow-up, the median PFS was 10.5 months (95% CI, 9.7-not reached), with a 6-month PFS rate of 80.0% (95% CI, 65.5-97.7). The median time to response (TTR) was 1.5 months, and the median duration of response (DOR) was 9.3 months. The OS remains immature. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 46.0% of patients. Hematologic toxicities were the most common treatment-emergent adverse events (TEAEs), and no fatal AE were observed.
Conclusion: First-line serplulimab and bevacizumab biosimilar combined with nab-P/Gem-mFOLFOX demonstrates clinical feasibility and promising preliminary outcomes in advanced PC. Further follow-up is required to confirm the survival benefits, and following analyses are needed to explore the mechanisms underlyingthe efficacy of this novel regimen.
Title: Efficacy and safety of serplulimab with DP induction chemotherapy followed by nimotuzumab and IMRT in locally advanced nasopharyngeal carcinoma: A retrospective study
Results: Among the 39 patients meeting eligibility criteria, the median age was 51 years; the median EBV DNA level was 554.0 copies/ml. Via TNM staging, 11(28%) patients were classified as T4 and 12(31%) patients as N3. 19(49%) patients were in stage III, and 20(51%) patients were in stage IVA. As of 31 Dec 2024, the median follow-up was 17 months. Among 38 patients in PPS(table), The CR was 71%, PR was 29%, with ORR and DCR both at 100%(95% CI 91-100). Median OS and PFS were not reached. The 1-year OS rate was 97.4% due to the unexplained death of one patient. Lower CR was noted among patients with T4 disease. Safety profile was consistent with previous reports, furthermore, patients with renal impairment experienced no additional adverse effects.
Conclusion: Serplulimab plus docetaxel and cisplatin induction chemotherapy followed by nimo with IMRT demonstrates promising efficacy and tolerability in treating LANPC.
Advanced solid tumours
Title: A phase 1 study of fixed-dose regimens of serplulimab, an anti-PD-1 antibody, in patients with advanced solid tumors
Results: As of Jan 5, 2024, 37 patients received at least one dose of serplulimab at 200 mg Q2W (n = 9), 300 mg Q3W (n = 9), 400 mg Q4W (n = 10), or 600 mg Q6W (n = 9). All patients were Asian, 70.3% male; median age was 60.0 yrs (range 33–88). Patients had head and neck cancer (n = 10, 27.0%), esophageal cancer (n = 6, 16.2%), colorectal cancer (n = 4, 10.8%) or other types of tumor. Most patients had metastatic disease (64.9%). All patients had prior systemic cancer treatment, including 4 (10.8%) with prior immunotherapy; 51.4% had ≥ 3 prior lines of therapy. All 37 patients were included in safety, pharmacokinetic (PK), and pharmacodynamics (PD) analyses; 35 response-evaluable patients were included in efficacy analysis. No dose-limiting toxicity was reported, and maximum tolerated dose (MTD) has not been determined. Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE. TRAE incidence was similar across regimen groups. Following multiple infusions, the geometric mean t½,ss was from 341.1–751.3 h, and geometric mean CLss was 0.006–0.009 L/h. Treatment-emergent anti-drug antibody (ADA) was detected in 7 (18.9%) patients. No difference in safety or PK was noted between ADA-positive and -negative patients. Profiles of PD-1 receptor occupancy in circulating CD3+ T cells and interleukin-2 stimulation ratio were similar across dose groups, suggesting dose-independent functional blockade. Six patients (300 mg Q3W, 4; 400 mg Q4W, 2) achieved partial response, resulting in an ORR of 17.1%. Among the responders, 12-month duration of response rate was 66.7% (95% CI confidence interval, 19.5–90.4). Median progression-free survival was 2.3 months (95% CI, 1.9–5.1).Conclusion: Fixed-dose regimens of serplulimab showed favorable safety, PK, and PD characteristics and preliminary anti-tumor activity, supporting its further investigation.
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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”).
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V. How we store your personal information
VI. Security measures
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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:
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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;
• Sharing your personal information with vendors or business partners (such as conference service providers, travel service providers, data service providers, banking or insurance institutions, other professional service organizations, to the extent necessary for the relevant purpose); and
• 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: PR@178xian.com
Cookies Policy
When you visit our website, we may place small data files known as “cookies” on your device. Cookies enable our website to recognize your browser and help us understand how visitors use the site.
Cookies and similar technologies used on this website may collect online identifiers, device information, browser information, IP address, and information about how you interact with the website. In certain circumstances, such information may constitute personal information or may be associated with you under applicable PRC laws and regulations. Information collected through cookies is used for purposes such as ensuring website operation, maintaining security, analyzing traffic and performance, remembering user preferences, and improving website content and user experience.
You may choose to accept or decline cookies by adjusting your browser settings or through any cookie banner or preference center made available on our website, if applicable. Please note that disabling cookies may affect the functionality of certain parts of the website.
For more information about how we process personal information, please refer to our Privacy Notice.
Some cookies may be provided by third parties. Where third-party cookies or similar technologies are used, such third parties may process the relevant information in accordance with their own privacy policies and applicable PRC laws and regulations.
Accessibility
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: PR@178xian.com
(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://www.178xian.com/) 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
