GlobeNewswire by notified

Junshi Biosciences Presents 11 Clinical Trials of Toripalimab at the ESMO Congress 2023

Share

SHANGHAI, China, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced the presentation of new clinical trial results at the European Society of Oncologists (“ESMO”) Immuno-Oncology Congress 2023, an international conference held in Madrid, Spain, from October 20th to 24th. At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters. These trials encompass ten diverse fields, including lung cancer, kidney cancer, head and neck cancer, breast cancer, colorectal cancer, cervical cancer, thymus cancer, and lymphoma.

“This year’s ESMO Congress highlighted the most recent results from 11 clinical studies conducted with our core product, toripalimab,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences. “Among these studies, the results of EXTENTORCH study involving small cell lung cancer and the RENOTORCH study focusing on renal cell carcinoma were presented for the first time. As ‘PD-1+X’ combination therapy achieves further clinical advancement across multiple indications, it will further bolster Junshi Biosciences’ extensive immuno-oncology pipeline, one that has been cultivated through many years of dedication.”

The RENOTORCH Study: Median PFS reaches 18.0 months! Record-setting results for 1st line immunotherapy in advanced kidney cancer

Led by Professor Jun GUO of Beijing Cancer Hospital and Professor Yiran HUANG of Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, RENOTORCH is China’s first phase III clinical study to focus on immunotherapy for advanced renal cell carcinoma. Study findings were unveiled for the first time during a proffered paper session at the ESMO Congress. Professor Xinan SHENG of Beijing Cancer Hospital gave a comprehensive overview of the research results in the oral presentation. The full manuscript of the study has also been published in Annals of Oncology (Impact factor 51.8) on the day of presentation.

The RENOTORCH study (NCT04394975) is a randomized, open-label, multicenter phase III clinical study that enrolled 421 patients from 47 medical centers with intermediate to high-risk unresectable or metastatic renal cell carcinoma (RCC) who had received no prior systematic treatment. RENOTORCH is the first pivotal phase III study of immunotherapy for advanced RCC in China.

As of March 31, 2023 (median follow-up time of 14.6 months), the RENOTORCH interim analysis results demonstrated that when compared to sunitinib monotherapy, toripalimab combined with axitinib significantly improved the patients’ progression-free survival (PFS) and objective response rate (ORR) while maintaining a manageable safety profile.

According to assessments by the independent review committee (IRC), the median PFS was 18.0 months in the toripalimab-axitinib group, nearly double that of the sunitinib group, which had a median PFS of 9.8 months. Toripalimab plus axitinib reduced the risk of disease progression or death by 35% (HR=0.65; 95% CI: 0.49-0.86; P=0.0028) compared to sunitinib. The 1-year and 2-year PFS rates of these two groups were 62.7% vs. 45.4% and 44.6% vs. 30.2%, respectively. Notably, unlike previous studies of a similar nature that included patients across all risk levels, this study only enrolled patients at intermediate to high risk and yet still achieved the longest median PFS ever reported in 1st line RCC.

When compared to patients in the sunitinib group, toripalimab-axitinib provided a superior ORR (IRC-assessed ORR of 56.7% vs. 30.8%, P<0.001) and a prolonged duration of response (DoR) (median DoR not yet reached vs. 16.7 months; HR=0.614; 95% CI: 0.340-1.137).

At the interim analysis, an OS trend favoring the toripalimab plus axitinib combination over sunitinib monotherapy (median OS not yet reached vs. 26.8 months) has also been demonstrated, with a 39% lower risk of death (HR=0.61; 95% CI: 0.40-0.92). The 1-year and 2-year OS rates of the toripalimab-axitinib group and sunitinib group were 90.5% vs. 81.9% and 71.8% vs. 63.2%, respectively.

The combination had a manageable safety profile and no new safety signals were identified.

In July 2023, based on RENOTORCH’s promising results, the National Medical Products Administration (NMPA) formally accepted the supplemental new drug application for toripalimab plus axitinib as the first-line treatment for patients with unresectable or metastatic RCC.

The EXTENTORCH Study: World’s 1st PD-1 inhibitor to achieve both positive PFS and OS results in phase III SCLC study

EXTENTORCH, a phase III study of toripalimab combined with chemotherapy as first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), made its debut as a late-breaking abstract at the ESMO Congress 2023. The study was led by principal investigator Professor Ying CHENG of Jilin Cancer Hospital, and presented by Professor Ying LIU from Jilin Cancer Hospital at the ESMO Congress.

The EXTENTORCH study (NCT04012606) is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study designed to compare the efficacy and safety of toripalimab vs. placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. EXTENTORCH enrolled a total of 442 ES-SCLC patients who had received no prior systematic treatment from 51 medical centers in China. In May 2023, EXTENTORCH successfully reached its primary endpoints, and toripalimab became the world’s first PD-1 inhibitor to achieve two primary endpoints, OS and PFS, in a phase III study of first-line treatment for ES-SCLC.

The findings from the EXTENTORCH study revealed that compared to chemotherapy alone, toripalimab plus chemotherapy for the first-line treatment of patients with ES-SCLC, coupled with toripalimab monotherapy as maintenance therapy, significantly prolonged PFS and OS while maintaining a manageable safety profile. With these promising results, toripalimab combined with chemotherapy is poised to become a standard first-line therapy for ES-SCLC.

The final PFS analysis (median follow-up time of 11.8 months) demonstrated that compared to chemotherapy alone, toripalimab combined with chemotherapy significantly improved patients’ PFS (researcher-assessed median PFS of 5.8 vs. 5.6 months) while reducing the risk of disease progression or death by 33% (HR=0.667; 95% CI: 0.539-0.824; P=0.0002).

Biomarker analyses revealed that both PFS and OS improved in the toripalimab-chemotherapy group, regardless of the patients’ tumor mutational burden (TMB) status. Additionally, mutations in focal adhesion/integrin pathway were associated with poorer PFS and OS prognoses in patients receiving toripalimab plus chemotherapy.

In terms of safety, toripalimab combined with chemotherapy has a manageable safety profile and no new safety signals were identified.

In July 2023, based on the EXTENTORCH trial results, the NMPA accepted the supplemental new drug application for toripalimab plus etoposide and platinum as the first-line treatment of ES-SCLC.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is China’s first self-developed anti-PD-1 monoclonal antibody, toripalimab. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Tenaris Announces 2023 Fourth Quarter and Annual Results21.2.2024 22:27:52 CET | Press release

The financial and operational information contained in this press release is based on audited consolidated financial statements presented in U.S. dollars and prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standard Board and adopted by the European Union, or IFRS Accounting Standards. Additionally, this press release includes non-IFRS alternative performance measures i.e., EBITDA, Free Cash Flow, Net cash / debt and Operating working capital days. See exhibit I for more details on these alternative performance measures. LUXEMBOURG, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) (“Tenaris”) today announced its results for the fourth quarter and year ended December 31, 2023 with comparison to its results for the fourth quarter and year ended December 31, 2022. Summary of 2023 Fourth Quarter Results 4Q 20233Q 2023 4Q 2022 Net sales ($ million)3,4153,2385%3,620(6%)Operating income ($

Standard Lithium to Participate in Upcoming Industry Conferences21.2.2024 22:05:14 CET | Press release

VANCOUVER, British Columbia, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSXV:SLI) (NYSE American:SLI) (FRA:S5L), a leading near-commercial lithium development company, today announced senior leadership participation in the following upcoming industry conferences: Event BMO 33rd Global Metals, Mining and Critical Minerals ConferenceDateFebruary 26 – 28, 2024PresentationRobert Mintak, CEO and Director, February 27 - 10:45 to 11:00am ETEvent BofA Global Agriculture and Materials Conference 2024DateFebruary 27 – 29, 2024PanelLithium Panel Discussion featuring Robert Mintak, CEO and Director, February 29 – 8:20 to 9:00am ETEvent 36th Annual Roth ConferenceDateMarch 17 – 19, 2024 Management will be hosting one-on-one meetings during the conferences. Interested investors should contact their BMO, Bank of America, or Roth representative or Standard Lithium Investor Relations at investors@standardlithium.com. About Standard Lithium Ltd. Standa

Lantronix Announces Percepxion™, Its New Cloud Software Platform for IoT Devices21.2.2024 22:05:00 CET | Press release

Percepxion™ comes pre-configured in Lantronix’s gateways, routers, trackers and switches to accelerate IoT edge device deployments IRVINE, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Lantronix Inc. (NASDAQ: LTRX), a global provider of compute and connectivity IoT solutions, today announced Percepxion™, its new Cloud IoT Edge Solutions platform. Percepxion is pre-configured into Lantronix’s award-winning IoT gateways, routers, trackers and switches to provide secure, comprehensive device lifecycle management. The Percepxion platform efficiently scales edge deployments from regional to global and is managed through an intuitive single pane of glass. “The Percepxion platform provides our customers with an easy-to-deploy IoT solution that comes pre-configured on our connect and compute products,” said Jacques Issa, vice president of Marketing at Lantronix Inc. “Percepxion’s multi-tenant feature enables a B2B solution, generating incremental revenue streams for our end customers.” Remote inst

Amaroq publishes a Supplementary Prospectus in connection with Fundraising21.2.2024 19:09:16 CET | Press release

TORONTO, ONTARIO, Feb. 21, 2024 (GLOBE NEWSWIRE) -- ("Amaroq" or the "Corporation" or the "Company") Amaroq publishes a Supplementary Prospectus in connection with Fundraising TORONTO, ONTARIO – 21 February 2024 – Amaroq Minerals Ltd. (AIM, TSX-V, NASDAQ Iceland: AMRQ), an independent mining company with a substantial land package of gold and strategic energy transition mineral assets in Southern Greenland, announces publication of a Supplementary Prospectus, consisting of a Supplement to the Registration Document dated 12 September 2023 and a Securities Note, along with a Summary, all dated 21 February 2024, related to fundraising, details of which were disclosed in announcements on 12 and 13 February 2024. The Supplementary Prospectus dated 21 February 2024, has been approved by the Financial Supervisory Authority of the Central Bank of Iceland. The Supplementary Prospectus which is written in English, has been published electronically to the company’s website https://www.amaroqminer

AMG Reports Record-Setting Earnings for the Full Year 202321.2.2024 18:04:58 CET | Press release

Amsterdam, 21 February 2024(Regulated Information) --- AMG Critical Materials N.V. (“AMG”, EURONEXT AMSTERDAM: “AMG”) reported record-setting adjusted EBITDA $350 million in 2023, due largely to strong profitability in our lithium and vanadium businesses. Fourth quarter 2023 revenue was $367 million, a 6% decrease versus the fourth quarter of 2022. Fourth quarter 2023 adjusted EBITDA of $71 million decreased 32% compared to the fourth quarter of 2022. Cash from operating activities was $223 million in 2023, the highest in AMG’s history, and 33% higher than the $168 million in 2022. In 000’s US dollarsQ4 ‘23Q4 ‘22ChangeFY ‘23FY ‘22ChangeRevenue$367,235$390,004 (6%)$1,625,861$1,642,774 (1%)Adjusted EBITDA (1)71,142104,061 (32%)350,491342,550 2%Cash from operating activities44,70456,969 (22%)223,000167,567 33%Return on Capital Employed 26.3% 30.8% 26.3% 30.8% Note: (1) Adjusted EBITDA is defined as EBIT adjusted for depreciation and amortization. Dr. Heinz Schimmelbusch, Chairman of the M

HiddenA line styled icon from Orion Icon Library.Eye