Sintilimab

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, Neoplasm, NDA, Cancer, Breakthrough therapy, Senior, HCM, HKEX, Dor, IRC, Prognosis, PFS, Ophthalmology, Pharmaceutical industry

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

Retrieved on: 
Wednesday, February 28, 2024
Neoplasm, RMB, SHPL, Net, EZH2, Growth, FC, Tax, Follicular lymphoma, FX, Fast Track, TCFD, Ethics, Marketing, RCC, Health, CER, Sintilimab, ITP, Disclosure, Plasma protein binding, Lancet, MET, Completeness, D-19, Paclitaxel, Met, NDA, NSCLC, EGFR, NRDL, Atopic dermatitis, ESG, CRC, PD-1, Completion, Phases of clinical research, Task force, Half-life, Chills, Potential, Breakthrough therapy, NMPA, Investment, FGFR, Research, PFS, AstraZeneca, EMA, ADS, Annual report, ASCO, FDA, Carbon accounting, VEGFR, Lung, COVID-19, Alopecia areata, PMDA, Lilly, Patient, Cancer, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

Adimab Provides 2023 Update on Clinical Pipeline

Retrieved on: 
Tuesday, January 9, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Engineering, Antibody, CD3, G protein-coupled receptor, Cytokine, Immunoglobulin G, Partner, Sintilimab, HC, Spacecraft, CD28, Complex, Protein, BLA, Compugen, Eurosport 1, FC, Vaccine

This brings the total number of Adimab partner programs that have entered the clinic to 74.

Key Points: 
  • This brings the total number of Adimab partner programs that have entered the clinic to 74.
  • Two additional products were approved and another BLA was filed in 2023.
  • “We are thrilled to have 12 new clinical programs initiated in 2023, especially given the constrained financial market that has impacted so many biotech companies over the past few years,” said Philip T. Chase, Chief Executive Officer of Adimab.
  • For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that allow for discovery against membrane-obligate proteins in their native state.

HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

Retrieved on: 
Wednesday, December 13, 2023
Quality of life, Axitinib, Shanghai Cancer Center, Everolimus, RECIST, HKEX, Fudan University, Sintilimab, RCC, TTR, Patient, Safety, Pharmaceutical industry

HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.

Key Points: 
  • HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.
  • The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC.
  • The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR).
  • If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration (“NMPA”).

HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses

Retrieved on: 
Friday, December 1, 2023
Stomach, Hepatocellular carcinoma, VEGFR, Cervical cancer, PD-1, Renal cell carcinoma, Endometrial cancer, Sintilimab, HCC, GC, RCC, Patient, Safety, EMC, NSCLC, BSC, Pharmaceutical industry

These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.

Key Points: 
  • These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.
  • Data from the EMC and RCC cohorts of this trial led to the initiation of registration enabling programs.
  • This combination treatment showed promising antitumor activity in advanced cervical cancer and NSCLC patients, particularly for patients with PD-L1 positive status.
  • Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3.

Innovent and Xuanzhu Enter into Clinical Trial Collaboration Investigating Combination Therapy of Sintilimab (PD-1 inhibitor) and A Novel ADC Candidate for Advanced Solid Tumors in China

Retrieved on: 
Thursday, December 28, 2023
Drug resistance, Immunotherapy, Intellectual property, HER2, IND, Autoimmunity, HKEX, PD-1, Eli Lilly, Clinical trial, Cancer, Sintilimab, Mutation, NMPA, Ophthalmology, NRDL, Patient, Safety, ADC, Endocytosis, Senior, Pharmaceutical industry

Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial.

Key Points: 
  • Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial.
  • Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors.
  • TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to collaborate with Xuanzhu Biopharma to explore the synergistic anti-tumor effects of the combination therapy of sintilimab and a novel ADC candidate.

HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Congress, Capecitabine, Sintilimab, Nanjing Medical University, HKEX, The First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Xinjiang Medical University, European Society for Medical Oncology, Oncology, Fudan University, Maintenance, Shanghai Cancer Center, Radiation, Patient

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain.
  • Details of the presentations are as follows:
    Fruquintinib plus Sintilimab in patients with either treatment naïve or previously treated advanced gastric or gastroesophageal junction adenocarcinoma: results from a multicenter, single-arm phase Ib/II study
    Xiaoli Wei, Harbin Medical University Cancer Hospital, Harbin, China
    First report of the safety/tolerability and preliminary antitumor activity of fruquintinib plus capecitabine versus capecitabine as maintenance treatment for metastatic colorectal cancer: an open-label, randomized phase Ib/II study
    Wenhua Li, Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
    Fuxiang Zhou, Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China
    Lu Wang, Liver surgery department, Fudan University Shanghai Cancer Center, Shanghai, China
    Pei Ma, Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Laekna, a Biotechnology Company in China, Listed on the Main Board of the Hong Kong Stock Exchange

Retrieved on: 
Thursday, June 29, 2023
IIA, Stock exchange, Bimagrumab, Prednisone, Sintilimab, Patient, Investment, Federal Medical Centres, Mab, Cornerstone, Prostate cancer, Biomedical Research, Clinical trial, Hepatic stellate cell, Research, Motherboard, Drug discovery, Knowledge, FDA, IND, Frost, Cirrhosis, Global Health Innovative Technology Fund, International, Biotechnology, Cancer, Breakthrough therapy, AKT, Core product, CYP17A1, CYP11B2, Social responsibility, Drug development, Liver disease, ATP, Drug resistance, Trust, Limited partnership, Multi, Hong Kong Stock Exchange, SCGC, HK, Management, Pharmaceutical industry, IPO, Novartis

HONG KONG, June 29, 2023 - (ACN Newswire) - A biotechnology company in China - Laekna, Inc. (stock code: 2105.HK), today listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange").

Key Points: 
  • HONG KONG, June 29, 2023 - (ACN Newswire) - A biotechnology company in China - Laekna, Inc. (stock code: 2105.HK), today listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange").
  • (2) Use for advancing the clinical development and approval of the other Core Product of the Company, LAE002.
  • The Hong Kong Offering also recorded an over-subscription, of approximately 5.81 times of the 6,373,000 shares offered.
  • The Company has established a number of global and regional partnerships with leading pharmaceutical companies, including Novartis and Innovent.

HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial Cancer, and Completes Enrollment of Registration Study

Retrieved on: 
Thursday, July 20, 2023
IRC, Breakthrough therapy, EMC, Sintilimab, HKEX, HIV disease progression rates, Patient, National Medical Products Administration, PD-1, NMPA, Safety, Pharmaceutical industry

A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.

Key Points: 
  • A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.
  • It is a multi-center, open-label clinical study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab.
  • Entry criteria include those EMC patients who experienced disease recurrence, disease progression or grade 3 or higher serious adverse events with treatment on platinum-based chemotherapy.
  • Favorable results from this trial could lead to submission to the NMPA in the first half of 2024 for regulatory approval in this treatment setting.