RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 315610456H

Source: *****

Clinical Trials associated with Envafolimab

NCT06772233

/ Not yet recruitingPhase 2IIT

A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment.

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

Start Date30 Jul 2025

Sponsor / Collaborator

Peking University

NCT04910386

/ Not yet recruitingPhase 2

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Start Date01 Jun 2025

Sponsor / Collaborator

3D Medicines (Sichuan) Co., Ltd.

NCT06959693

/ Not yet recruitingPhase 2/3IIT

mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS/BRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase Ⅱ/Ⅲ Trial

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Start Date01 Jun 2025

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Envafolimab

100 Translational Medicine associated with Envafolimab

100 Patents (Medical) associated with Envafolimab

Literatures (Medical) associated with Envafolimab

01 Sep 2025·JOURNAL OF CONTROLLED RELEASE

A super-long-acting anti-PD-L1 nanobody fused to elastin-like polypeptide for triple-negative breast cancer immunotherapy

Article

Author: Gao, Weiping ; Yang, Zhaoying ; Zhang, Fan ; Sun, Yuanzi ; Yao, Qiongqiong

The limited tumor penetration of monoclonal antibodies or the rapid renal clearance of nanobodies hamper their application in cancer immunotherapy. Through genetic engineering, we fuse a thermosensitive elastin-like polypeptide of ELP(V) with a nanobody of KN035 that binds specifically to human programmed cell death protein ligand 1 (PD-L1) to generate a conjugate of KN035-ELP(V) for triple-negative breast cancer (TNBC) therapy. The high affinity of KN035-ELP(V) enables it to efficiently block the interaction of PD1 and PD-L1. A single intraperitoneal administration of KN035-ELP(V) leads to the in situ generation of a sustained-release depot, showing a circulating half-life that is 276.4-fold and 5.1-fold longer than those of KN035 and KN035 fused with fragment crystallizable (KN035-Fc), respectively. Additionally, KN035-ELP(V) outperforms KN035 and KN035-Fc in term of accumulation and penetration in tumor tissue. Compared to KN035 and KN035-Fc treatments, a single injection of KN035-ELP(V) induces a durable and efficient antitumor immunity in TNBC-bearing mice, resulting in improved anti-tumor efficacy with reduced adverse effects. Therefore, KN035-ELP(V) is promising as a super-long-acting anti-PD-L1 nanobody for efficient cancer immune checkpoint blockade therapy.

01 Jun 2025·Thoracic Cancer

Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real‐World Study

Article

Author: Zhang, JieLi ; Wang, Hanping ; Yang, Yulong ; Zhang, Xiaotong ; Rui, Meng ; Si, Xiaoyan ; Zhou, Yunzhi ; Zhang, Li ; Wang, Mengzhao ; Zhao, Qiuhong ; Dou, Zixuan ; Cui, Xiaoxia ; Wang, Li

ABSTRACT:

Background:

Envafolimab is a novel immune checkpoint inhibitor (ICI) with several advantages due to its subcutaneous administration. Phases I and II randomized controlled trials have demonstrated promising efficacy in treating colorectal and gastric cancer. However, the safety and efficacy of Envafolimab in patients with advanced lung cancer remain to be investigated.

Methods:

This retrospective, multicenter, open‐label, single‐arm cohort study examined real‐world medical data from patients treated at four medical centers to assess the safety and efficacy of Envafolimab in treating patients with advanced lung cancer. The primary safety outcome was Envafolimab‐related treatment‐emergent adverse events (TEAEs) and immune‐related adverse events (irAEs). The primary efficacy outcomes included overall survival (OS) and progression‐free survival (PFS). Then, the relationship between clinical parameters and prognosis was investigated using univariate and multivariate regression analyses. Furthermore, the impact of tumor EGFR driver mutation status and PD‐L1 expression on prognosis was explicitly explored in patients with nonsmall‐cell lung cancer (NSCLC).

Results:

The cohort comprised 58 patients with a median follow‐up time of 8.3 months (from March 1, 2022, to March 7, 2024). Envafolimab‐related TEAEs and irAEs were observed in 53.4% and 27.6% of patients, respectively. No specific clinical factors were identified as being associated with irAEs. The median OS was 8.5 months (95% confidence interval [CI] 6.2–10.8), and the median PFS was 6.1 months (95% CI 3.8–8.3). For 47 patients with NSCLC, factors including ECOG PS > 2 (HR: 2.91, p = 0.015), Stage IV tumor (HR: 3.43, p = 0.043), and nonfirst‐line Envafolimab treatment (HR: 3.27, p = 0.026) were associated with poor prognosis.

Conclusion:

Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.

01 Apr 2025·HEPATOLOGY

A randomized phase 2b study of subcutaneous PD-L1 antibody ASC22 in virally suppressed patients with chronic hepatitis B who are HBeAg-negative

Article

Author: Xie, Qing ; Yang, Yongfeng ; Fu, Lei ; Wu, Jinzi J. ; Mao, Qianguo ; Chen, Yongping ; Xie, Yao ; Cui, Yimin ; Qian, Jiandan ; Guo, Xiaolin ; Zhang, Qin ; Wang, Guiqiang ; Chen, Xinyue ; Lu, Jiajie ; Hou, Jinlin ; Gu, Ye ; Hu, Guoxin ; Yan, Yuemei ; Zou, Guizhou

Background and Aims::

Studies have shown that blocking the programmed cell death-1/programmed cell death ligand 1 pathway may lead to a potential cure for HBV infections. ASC22 (envafolimab) is a humanized, single-domain programmed cell death ligand 1 antibody administered subcutaneously. This study aimed to evaluate the efficacy and safety of ASC22 in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs.

Approach and Results::

This randomized, single-blind, phase IIb trial enrolled patients with chronic hepatitis B in 2 cohorts for a 24-week treatment with ASC22 or placebo (PBO) once every 2 weeks and 24-week follow-up. In total, 60, 59, and 30 patients were treated with 1.0, 2.5 mg/kg ASC22, and PBO, respectively. The mean changes in HBsAg from baseline at weeks 24 and 48 were −0.309 (p < 0.001) and −0.272 (p < 0.023) log10 IU/mL in the 1.0 mg/kg ASC22 group, −0.231 (p = 0.007) and −0.205 (p = 0.12) log10 IU/mL in the 2.5 mg/kg ASC22 group, and −0.003 and −0.063 log10 IU/mL in the PBO group, respectively (intent-to-treat population). Three out of 10 patients with baseline HBsAg levels ≤100 IU/mL in the 1.0 mg/kg group obtained on-treatment HBsAg loss. Most adverse events were mild (97.9%). There were no study drug–related serious adverse events in the 1.0 mg/kg ASC22 group.

Conclusions::

Subcutaneous administration of 1.0 mg/kg ASC22 once every 2 weeks for 24 weeks was shown to be safe and well-tolerated in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs and can induce HBsAg decline, especially in patients with HBsAg ≤100 IU/mL.

113

News (Medical) associated with Envafolimab

23 May 2025

·www.einpresswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 2ASCOPhase 3Phase 1

19 Nov 2024

·pharma.economictimes.indiatimes.com

Glenmark to focus on becoming branded company, says Glenn Saldanha

Mumbai: Glenmark is focusing on moving up the value chain to transform into a branded pharmaceutical company with a significant portion of its revenue coming from higher-margin branded products, having overcome a challenging period, its chairman and managing director Glenn Saldanha told ET. “I think we've come a long way… We had three, four difficult years,” he said, citing issues with the US Food and Drug Administration (FDA), the Department of Justice (DOJ) and some litigations. “Lots of challenges we faced… All that is behind us,” Saldanha added. “I think now things are much better. So, the platform is set to continue to scale and to grow faster.” On some analysts raising doubts about Glenmark’s way forward after the sale of Glenmark Life Sciences (GLS), its active pharmaceutical ingredient business, and some branded portfolios, Saldanha said, “We've done some portfolio rationalisation, and the GLS divestment was because our view was, given the changing dynamic in the generics business, we didn't find the need to keep the API business within our portfolio. The sale helped us to re-channelise our entire energies into becoming a branded company.” He said the “aggression and the passion” are intact and the company isn't going to slow down. “We will not give up (on) scale.” Glenmark has been cleaning up its balance sheet. It used the proceeds from GLS divestment to pare debt. It currently has a debt-to-equity ratio of 0.16%. The company halved its expenditure on R&D from $120-130 million per annum at its peak to about $60 million through a series of out-licensing deals. Saldanha said the company will record Rs 13,500-14,000 crore of revenues this year, growing at about 12%-15% CAGR, and reach about Rs 15,500 crore next year. Almost 65% of its revenues are coming from branded business, which gives the business stability from pricing pressures, he said. Glenmark ended FY24 with revenue of around Rs 10,944 crore in revenue with an Ebitda margin of 19%. India contributes one-third of its revenue, while the US accounts for 28% and Europe 12%. Saldanha said the company will increasingly focus on three therapeutic segments – respiratory, dermatology and oncology – for its branded business. In early January, Glenmark became the first Indian company to launch a biosimilar of anti-diabetic GLP-1 drug Liraglutide in the country. It has also announced a series of partnerships to bring innovative drugs including tie-ups with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines for KN035 (Envafolimab) for multiple geographies around the world. It partnered with Pfizer to launch Abrocitinib, used for treating atopic dermatitis in India under the brand name Jabryus. It has entered into an agreement with BeiGene for marketing and distribution of Tislelizumab and Zanubrutinib in India. By Viswanath Pilla ,

AcquisitionLicense out/inDrug Approval

31 Jul 2024

·www.fiercebiotech.com

Tracon winds down weeks after world's first injectable PD-L1 inhibitor stumbles in phase 2

Following a special meeting of its board of directors, Tracon Pharmaceuticals has terminated employees and will wind down operations. Tracon Pharmaceuticals has decided to wind down operations weeks after an injectable immune checkpoint inhibitor that was licensed from China flunked a pivotal trial in a rare cancer.The biotech gave up on envafolimab after the subcutaneous PD-L1 inhibitor only triggered responses in four out of 82 patients who had already received therapies for their undifferentiated pleomorphic sarcoma or myxofibrosarcoma. At 5%, the response rate was below the 11% the company had been aiming for.The disappointing results ended Tracon’s plans to submit envafolimab to the FDA for approval as the first injectable immune checkpoint inhibitor, despite the drug having already secured the regulatory green light in China.At the time, CEO Charles Theuer, M.D., Ph.D., said the company was moving to “immediately reduce cash burn” while seeking out strategic alternatives.It looks like those options didn’t pan out, and, this morning, the San Diego-based biotech said that following a special meeting of its board of directors, the company has terminated employees and will wind down operations. As of the end of 2023, the small biotech had 17 full-time employees, according to its annual securities filing.It’s a dramatic fall for a company that only weeks ago was eyeing the chance to cement its position with the first subcutaneous checkpoint inhibitor approved anywhere in the world. Envafolimab claimed that title in 2021 with a Chinese approval in advanced microsatellite instability-high or mismatch repair-deficient solid tumors regardless of their location in the body. The tumor-agnostic nod was based on results from a pivotal phase 2 trial conducted in China.Tracon in-licensed the North America rights to envafolimab in December 2019 through an agreement with the drug’s Chinese developers, 3D Medicines and Alphamab Oncology.

Phase 2ImmunotherapyClinical ResultDrug ApprovalLicense out/in

100 Deals associated with Envafolimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colorectal Cancer	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021
Microsatellite Instability-high Solid Tumors	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Nov 2023
Non-small cell lung cancer stage IIIB	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	17 Nov 2023
Locally Advanced Rectal Carcinoma	Phase 3	China	Sir Run Run Shaw Hospital	01 Apr 2023
Bile Duct Neoplasms	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Bile Duct Neoplasms	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Advanced biliary tract cancer	Phase 3	-	3D Medicines (Shanghai) Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


["ENLEN-OC-001"] (Pubmed \| Oncologist)	Phase 2	Platinum-Resistant Ovarian Carcinoma	18	Envafolimab + Lenvatinib + Etoposide	mqdmqzodmb(flvrkffmwe) = ctyefamliu cdtemtiujs (scdintaiol, 21.5 - 69.2) View more	Positive	14 Jul 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	exivgencph(wglikynsvb) = pzlegbnwes fvpatnfskz (ianvaclzcz, 15.6 - 55.3) View more	Positive	30 May 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	exivgencph(wglikynsvb) = mxmavqedne fvpatnfskz (ianvaclzcz, 0.5 - 14.8) View more	Positive	30 May 2025
NCT05828381 (Phase II study, ASCO2025)	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	32	Envafolimab + Albumin-bound Paclitaxel + Cisplatin	bnzhujilrq(yjyxklgopx) = One patient occurred cerebral hemorrhage abdsqsrnvg (jryuulowbw ) View more	Positive	30 May 2025
NCT05243355 (ASCO2025)	Phase 2	Squamous non-small cell lung cancer First line	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	lzgdbwabos(rpzagxcwlu) = oznczpgqco smzbitzmas (udhjdhfifr, 43.0% - 83.3%) View more	Positive	30 May 2025
ChiCTR2100044981 (ASCO2025)	Phase 2	Extensive stage Small Cell Lung Cancer First line	32	Envafolimab + Carboplatin + Etoposide	tesohhrbea(oubryeakea) = lnouqyvoqe twdelgyrmx (ccahaidtdk, 4.83 - 7.67) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Advanced Malignant Solid Neoplasm dMMR \| microsatellite instability high (MSI-H)	17	Envafolimab monotherapy	snkahsfmju(ldgqzpywjq) = avihgeliep awtxcpvuht (yrwmvypuff ) View more	Positive	30 May 2025
NCT05910034 (ASCO2025)	Phase 2	Non-Small Cell Lung Cancer Second line PD-1 inhibitors	25	Trilaciclib+Envafolimab+Docetaxel	thurgrvulv(tmadvfuyfz) = Hematological toxicity occurred in 17/25 (68%) pts during the first cycle, with a lower incidence in cohort A compared to cohorts B and C bmateoznng (moxiapgnmz ) View more	Positive	30 May 2025
NCT05910034 (ASCO2025)	Phase 2	Non-Small Cell Lung Cancer Second line PD-1 inhibitors	25	Docetaxel+Envafolimab		Positive	30 May 2025
NCT06030934 (ASCO_GI2025) Manual	Phase 2	Advanced Gastroesophageal Junction Adenocarcinoma Second line Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts who never received PD-1 or PD-L1 inhibitors before)	wnnwiecmxq(mqptcgrqcs) = zwznbomgbi ufhojysodh (laygsetejt ) View more	Positive	23 Jan 2025
NCT06030934 (ASCO_GI2025) Manual	Phase 2		30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts have failed first-line PD-1 antibody combined chemotherapy, with optimal efficacy as or above stable disease)	wnnwiecmxq(mqptcgrqcs) = eozimbtlmm ufhojysodh (laygsetejt ) View more	Positive	23 Jan 2025
NCT05529355 (ESMO_ASIA2024) Manual	Phase 2	Non-Small Cell Lung Cancer Last line \| Second line	20	Envafolimab 150mg + Chemotherapy/Anti-VEGF	ogdtjgfavp(nsoyhghvhu) = qanqcsrbte qskllmmdab (ytvzhehhiu ) View more	Positive	07 Dec 2024
ChiCTR2200055407 (Pubmed)	Phase 2	Hepatocellular Carcinoma First line	36	仑伐替尼+恩沃利单抗	ckqwmibufe(myiinurpyn) = dficthgkqn fhhkhuvdut (smxvmhsrvf ) View more	Positive	01 Dec 2024

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