SHANGHAI, July 17, 2024 (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 that the National Medical Products Administration (NMPA) has accepted for review the supplemental new drug application (sNDA) for toripalimab (trade name: TUOYI, product code: JS001) combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Liver cancer is a common malignant tumor of the digestive system worldwide, and the predominant pathological type is HCC (accounting for about 90% of global cases). According to the 2022 GLOBOCAN Report, there were 866,000 new cases and 759,000 deaths from liver cancer globally that year. China is particularly affected by liver cancer, with new liver cancer cases reaching 368,000 (accounting for 42.4% of global cases) in 2022, ranking fourth in new cases among domestic malignant tumors, and the number of deaths reaching 317,000 (accounting for 41.7% of global cases), ranking second among domestic malignant tumors. Due to its insidious onset, about 70%-80% of liver cancer patients in China are already at the intermediate or advanced stage upon first diagnosis, with a median OS of approximately only 10 months and a 5-year survival rate of approximately 12%. In recent years, the continuous emergence of combination therapies based on immunotherapy drugs has transformed the treatment landscape of advanced liver cancer, and achieving a radical cure after downstaging is gradually becoming a possibility.
The sNDA is based on the HEPATORCH study (NCT04723004), a multicenter, randomized, open-label, active-controlled phase III clinical study aiming to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib. Conducted across 57 centers nationwide in China, HEPATORCH was led by Principal Investigator Professor Jia FAN, President of Zhongshan Hospital affiliated to Fudan University and academician of the Chinese Academy of Sciences.
In June 2024, the primary endpoints of progression-free survival (PFS, based on independent radiological review) and overall survival (OS) of the HEPATORCH study met the pre-defined efficacy boundary. The results of the study showed that toripalimab in combination with bevacizumab for the first-line treatment of patients with advanced HCC could significantly prolong the PFS and OS of the patients compared with sorafenib, while improving the secondary endpoints such as objective response rate and time to progression. The safety profile of toripalimab was consistent with the known risks, and no new safety signals were identified. Further details will be presented at a future international academic conference.
Principal investigator Professor Jia FAN, Academician of Chinese Academy of Sciences and President of Zhongshan Hospital, said, "Due to the hidden onset of HCC, most domestic patients have already missed the opportunity for radical surgery at the time of initial diagnosis. The HEPATORCH study results show that first-line treatment of advanced HCC with toripalimab combined with bevacizumab offers significant survival benefits. The study also reaffirms the efficacy of combining immunosuppressants with anti-angiogenesis targeting drugs for advanced HCC. We eagerly await the approval of this therapy that combines toripalimab with bevacizumab, which will provide new treatment options for advanced HCC patients in China!"
"I'm delighted to see the successful submission of the sNDA for toripalimab's 11th indication," General Manager and CEO of Junshi Biosciences, Dr. Jianjun ZOU, said. "Since receiving marketing approval in 2018 as the first domestically developed anti-PD-1 monoclonal antibody, toripalimab has targeted the unmet needs of cancer patients in China and even internationally. As of now, it has been approved for 10 indications in 7 cancer types, many of which are exclusive indications. This sNDA is toripalimab's first indication in liver cancer, and once again, toripalimab is demonstrating its 'broad-spectrum' when battling cancer. Going forward, we will actively communicate with regulatory authorities to speed up the approval of this indication, so that more advanced liver cancer patients can benefit from our innovative therapy."
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system's ability to attack and kill tumor cells.
More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.
In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are eight approved indications for toripalimab in the Chinese mainland:
- unresectable or metastatic melanoma after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
- in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
- in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
- in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
- in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
- in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
- in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC).
The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
In the United States, the US FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).
In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.
In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.
In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (HSA) in January 2024. The HSA has also granted priority review designation for the NDA.
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 toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. 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:
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
上海,2024年7月17日(GLOBE NEWSWIRE)——致力於新療法發現、開發和商業化的領先創新驅動型生物製藥公司上海君實生物科學股份有限公司(君實生物科技,香港交易所:1877;上交所:688180)宣佈,國家藥品監督管理局(NMPA)已接受麻醉藥補充新藥申請(snDa)的審查奧利單抗(商品名:TUOYI,產品代碼:JS001)與貝伐珠單抗聯合用於不可切除或轉移性肝細胞癌的一線治療(HCC)。
肝癌是全球消化系統的常見惡性腫瘤,主要病理類型是肝癌(約佔全球病例的90%)。根據2022年GLOBOCAN報告,當年全球有86.6萬例肝癌新發病例和75.9萬例死亡。中國尤其受到肝癌的影響,2022年肝癌新發病例達到36.8萬例(佔全球病例的42.4%),在國內惡性腫瘤中新發病例中排名第四,死亡人數達到31.7萬例(佔全球病例的41.7%),在國內惡性腫瘤中排名第二。由於其發病隱性,中國約70%-80%的肝癌患者在首次診斷時已經處於中期或晚期,中位操作系統只有大約10個月,5年生存率約爲12%。近年來,基於免疫療法藥物的聯合療法的不斷出現改變了晚期肝癌的治療格局,在降期後實現根本性治癒已逐漸成爲可能。
該snDA基於HEPATORCH研究(NCT04723004),這是一項多中心、隨機、開放標籤、主動對照的III期臨床研究,旨在評估與索拉非尼標準治療相比,託瑞帕利單抗與貝伐珠單抗聯合用於不可切除或轉移性肝癌一線治療的療效和安全性。HEPATORCH在中國全國57箇中心開展,由首席研究員、復旦大學附屬中山醫院院長、中國科學院院士範佳教授領導。
2024年6月,HEPATORCH研究的無進展生存期(PFS,基於獨立放射學審查)和總存活率(OS)的主要終點達到了預定義的療效界限。研究結果表明,與索拉非尼相比,託利單抗與貝伐珠單抗聯合用於晚期肝癌患者的一線治療,可以顯著延長患者的PFS和操作系統,同時改善客觀反應率和進展時間等次要終點。託利單抗的安全特徵與已知風險一致,沒有發現新的安全信號。更多細節將在未來的國際學術會議上公佈。
首席研究員、中國科學院院士、中山醫院院長範佳教授說:“由於肝癌的隱性發作,大多數國內患者在初步診斷時已經錯過了根治性手術的機會。HEPATORCH的研究結果表明,使用託利單抗聯合貝伐珠單抗對晚期肝癌進行一線治療可帶來顯著的生存益處。該研究還重申了將免疫抑制劑與抗血管生成靶向藥物聯合治療晚期肝癌的療效。我們熱切地等待這種結合託瑞帕利單抗和貝伐珠單抗的療法獲得批准,它將爲中國的晚期肝癌患者提供新的治療選擇!”
君實生物科技總經理兼首席執行官鄒建軍博士說:“我很高興看到託利單抗第11個適應症的snDA成功提交。”“自2018年作爲首款國內開發的抗PD-1單克隆抗體獲得上市批准以來,託利單抗一直針對中國乃至國際癌症患者未滿足的需求。截至目前,它已獲准用於7種癌症類型的10種適應症,其中許多是獨家適應症。該snDA是託利單抗在肝癌中的第一個適應症,託利單抗再次證明了其在對抗癌症時的 “廣譜”。展望未來,我們將積極與監管機構溝通,以加快該適應症的批准,以便更晚期的肝癌患者可以從我們的創新療法中受益。”
關於託利帕利單抗
託瑞帕利單抗是一種抗PD-1單克隆抗體,因其能夠阻斷PD-1與其配體 PD-L1 和 PD-L2 的相互作用以及增強受體內化(內吞功能)而開發。阻斷 PD-1 與 PD-L1 和 PD-L2 的相互作用可增強免疫系統攻擊和殺死腫瘤細胞的能力。
君實生物科學已在全球範圍內開展了四十多項由公司贊助的託瑞帕利單抗臨床研究,涵蓋了超過十五種適應症,包括在中國、美國、東南亞和歐洲。正在進行或已完成的評估託利單抗安全性和有效性的關鍵臨床試驗涵蓋多種腫瘤類型,包括肺癌、鼻咽癌、食道癌、胃癌、膀胱癌、乳腺癌、肝癌、腎癌和皮膚癌。
在中國大陸,託利單抗是國內首個獲准上市的抗PD-1單克隆抗體(在中國獲批爲拓益)。目前,託利單抗在中國大陸有八種獲批的適應症:
- 標準全身治療失敗後無法切除或轉移的黑色素瘤;
- 在先前的至少兩條全身治療失敗後,複發性或轉移性鼻咽癌(NPC);
- 含鉑化療失敗或在新輔助或輔助含鉑化療後 12 個月內進展的局部晚期或轉移性尿路上皮癌;
- 與順鉑和吉西他濱聯合用作局部複發性或轉移性鼻咽癌患者的一線治療;
- 與紫杉醇和順鉑聯合用於不可切除的局部晚期/複發性或遠處轉移性食管鱗狀細胞癌(ESCC)患者的一線治療;
- 與培美曲塞和鉑聯合用作表皮生長因子突變陰性和ALK突變陰性、不可切除、局部晚期或轉移性非鱗狀非小細胞肺癌(NSCLC)的一線治療;
- 與化療聯合作爲圍手術期治療,隨後與單一療法聯合作爲輔助療法,用於治療可切除的IIIA-IIB期非小細胞肺癌的成年患者;
- 與阿西替尼聯合用於中到高風險不可切除或轉移性腎細胞癌(RCC)患者的一線治療;
- 與依託泊苷加鉑聯合用於廣泛期小細胞肺癌(ES-SCLC)的一線治療;
- 與注射用紫杉醇(白蛋白結合型)聯合用於複發性或轉移性三陰性乳腺癌(TNBC)的一線治療。
前六種適應症已被納入國家報銷藥品清單(NRDL)(2023年版)。託利單抗是NRDL中唯一一種用於治療黑色素瘤的抗PD-1單克隆抗體。2024年4月,香港特別行政區政府衛生署藥物辦公室接受了託利單抗與順鉑和吉西他濱聯合用於一線治療局部晚期鼻咽癌的成年人的保密協議,以及託利單抗作爲單一藥物的保密協議,用於治療復發、不可切除或轉移性鼻咽癌的成年人含鉑化療期間或之後出現疾病進展的PC。
在美國,美國食品藥品管理局批准了託利單抗聯合順鉑和吉西他濱的生物製劑許可申請,用於一線治療轉移性或複發性局部晚期鼻咽癌的成年人,以及託瑞帕利單抗作爲單一藥物,用於治療在含鉑化療期間或之後出現疾病進展的復發、不可切除或轉移性鼻咽癌的成年人於 2023 年 10 月。美國食品藥品管理局已授予治療鼻咽癌的託利單抗2突破性療法稱號,1項用於治療粘膜黑色素瘤的快速通道稱號,以及5種用於治療食管癌、NPC、粘膜黑色素瘤、軟組織肉瘤和小細胞肺癌(SCLC)的孤兒藥稱號。
在歐洲,歐洲藥品管理局(EMA)和MHRA接受了以下申請的上市許可申請(MAA):1)託利單抗聯合順鉑和吉西他濱用於局部復發或轉移性鼻咽癌患者的一線治療;2)託利單抗聯合紫杉醇和順鉑用於一線治療局部晚期/複發性不可切除患者的上市許可申請(MAA)轉移性 ESCC,於 2022 年 12 月和 2023 年 2 月。
在澳大利亞,新的化學實體(NCE)申請於2023年11月被澳大利亞治療用品管理局(TGA)接受。TGA還授予託利單抗治療鼻咽癌的孤兒藥稱號。
在新加坡,保密協議的申請於2024年1月被新加坡健康科學管理局(HSA)接受。HSA還批准了NDA的優先審查指定。
關於君實生物科技
君實生物科技(香港交易所:1877;上交所:688180)成立於2012年12月,是一家以創新爲導向的生物製藥公司,致力於創新療法的發現、開發和商業化。該公司已經建立了多元化的研發渠道,包括50多種候選藥物,五個治療重點領域涵蓋癌症、自身免疫、代謝、神經系統和傳染病。該公司的四項創新已經進入中國或國際市場,其中之一是託利單抗,這是中國首個國產和自主開發的抗PD-1單克隆抗體,已在中國和美國獲得批准。此外,目前有30多種藥物正在臨床開發中。在 COVID-19 疫情期間,君實生物科學積極承擔了一家中國製藥公司的社會責任,參與開發依替西維單抗、明德威和其他用於預防和治療 COVID-19 的新療法。
君實生物以 “爲患者提供世界一流、值得信賴、價格合理的創新藥物” 爲使命,“在中國,面向全球”。目前,該公司在美國(舊金山和馬里蘭州)和中國(上海、蘇州、北京、廣州等)擁有約3,000名員工。欲了解更多信息,請訪問:
君實生物科學聯繫信息
投資者關係團隊:
君實生物科技
info@junshipharma.com
+ 86 021-6105 8800
公關組:
君實生物科技
李智
zhi_li@junshipharma.com
+ 86 021-6105 8800