美通社

2024-12-30 13:28

Alphamab Oncology Announced Anti-HER2 Bispecific ADC JSKN003 Received Approval from CDE to Initiate a Phase III Clinical Study for Ovarian Cancer

SUZHOU, China, Dec. 27, 2024 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (study number: JSKN003-306). The study aims to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Ovarian cancer (OC) ranks as the third most common gynecologic malignancy in China and continues to show a rising incidence, with the highest mortality rate among all malignant gynecologic tumors. The standard treatment regimens recommended by authoritative guidelines both domestically and internationally include surgery combined with platinum-based chemotherapy and targeted therapy maintenance. However, about 70% of OC cases recur after treatment and progress to platinum-resistant ovarian cancer (PROC), leaving patients with limited effective treatment options and poor prognosis. The 2024 NCCN guideline recommend non-platinum cytotoxic drugs and targeted monotherapy as the preferred treatment option for patients with PROC. Previous studies have shown that the objective response rate (ORR) of PROC treated with non-platinum chemotherapy alone is only 4% to 13%, while the ORR for non-platinum chemotherapy combined with targeted therapy is merely 10% to 30%, highlighting an urgent need for new treatment options.

JSKN003 is an anti-HER2 bispecific ADC, which is developed inhouse with Alphamab's proprietary Glycan-specific conjugation platform. Multiple clinical studies of JSKN003 are currently being conducted in Australia and China. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors. Data from two Phase I clinical studies of JSKN003 for the treatment of PROC presented at the 2024 European Society for Medical Oncology (ESMO) Congress indicated that JSKN003 monotherapy showed promising efficacy signals in patients with advanced PROC, and the efficacy was observed across patients with or without HER2 expression, prior bevacizumab treatment, prior PARP inhibitor treatment, and whether they were primary platinum-resistant.

JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for the all-comer population with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have received 1-4 lines of prior treatment. The study aims to compare the efficacy and safety of JSKN003 versus investigator-selected chemotherapy in this patient population.

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab's proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC) or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company committed to the development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. On December 12, 2019, the company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.

Our integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. We take pride in our extensive intellectual property portfolio, which encompasses protein/antibody engineering, antibody screening, and multi-module/multi-functional antibody modification.

Distinguished by a globally competitive pipeline, Alphamab Oncology specializes in antibody-drug conjugation (ADC), single domain antibody, and bispecific antibodies. Notably, Envafolimab, the world's first subcutaneously injectable PD-L1 inhibitor, was approved by Chinese authorities in 2021, making a significant breakthrough in the convenience and accessibility of cancer treatment. Three assets are currently undergoing Phase III or pivotal clinical trials, and several other bispecific ADC new drug candidates are in early clinical stage. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, Arrivent, and Glenmark.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is dedicated to the development of safe, effective and affordable drugs, leveraging a global competitive edge.

source: Alphamab Oncology

【你點睇?】美國總統特朗普批評烏克蘭總統澤連斯基是「一位未經選舉的獨裁者」,俄烏戰爭早應停止。你是否認同特朗普的說法?► 立即投票

人氣文章
最近7天
1
港股 | 蕭猷華:內地AI發展迅速,阿里巴巴股價看俏
2
高息定存 | 一周高息合集,銀行高息搶存,富邦1個月4.88厘,華僑1年期3.6厘
3
PapaHome淘寶家具實體店22日開幕,選址尖沙咀中港城,料創100個就業機會
4
高息定存 | 華僑銀行推新春港元定存優惠,88天或188天享3.68厘
5
英偉達 | DeepSeek衝擊AI晶片行業結構 英偉達暴跌仍未急抄底
6
高息定存 | 一周高息合集,蛇年定存金蛇起舞,1個月定存高達8厘
7
啟德體育園明天足球賽測試,4.4萬公僕參與涉逾400萬車馬費
8
電騙 | 黃俊碩:多管齊下,防治內地留學生受騙
9
環球央行 | 歐洲央行宣布再次減息0.25厘,符合市場預期
10
一本萬利 | 2025年的五個「勿」(有片)
11
易經看世界 | 乙巳蛇年趨吉五招:言行注意甚麼?應遠離甚麼人?(有片)
12
專訪 | 關稅戰 | 香港物流協會副會長梁庭彰:美物流商停收包裹對跨境電商打擊重大
13
高息定存 | 一周高息合集,減息預期降溫,銀行3個月最高5.68厘,6個月3.55厘
14
港股 | 午市前瞻 | iPhone SE難救中國市場 專家提醒比電已超買
15
【FOCUS】螺絲殼裏做道場,DeepSeek致勝啟示
16
大S | 台灣藝人徐熙媛因流感併發肺炎逝世,享年48歲
17
DeepSeek推出即上蘋果中國區榜首,能力直追OpenAI
18
【FOCUS】悟空、哪吒、DeepSeek,如何啟示香港
19
日入而息 | 習近平據報下周見科企領袖,證監會審視8券商孖展風控,大酒店轉蝕9億
20
收市短打 | 楊韻銳:港股升勢有成交配合 惟留意關鍵阻力位!
21
新世界 | 摩通:新世界若債務違約或打開行業「潘朵拉盒子」
22
港股 | 午市前瞻 | AI應用概念炒作有錢途 下階段部署邊隻好?
23
【FOCUS】侵侵呼籲全球「降息」,日銀祭18年最激進加息
24
彭博亞洲20大富裕家族,香港5大家族上榜,新地郭氏排名最高,無李嘉誠李兆基?
25
港股 | 蕭猷華:春節假後,恒指逐步上望21000點
26
高息定存 | 信銀國際12個月港元定存高達3.5厘
27
神州經脈 | 特朗普或與華討論關稅,人民幣大漲,滬指連升兩周
28
David Webb:因病情惡化,將有序結束個人財經網站
29
民營企業座談會 | 習近平在京出席民營企業座談會
30
AI | 蔡崇信確認阿里與蘋果合作,撰文談DeepSeek崛起帶來兩大啟示
專業版
HV2
精裝版
SV2
串流版
IQ 登入
強化版
TQ
強化版
MQ

etnet榮膺「第九屆傳媒轉型大獎」四大獎項

【限時優惠$68/月】申請etnet強化版MQ手機串流報價服務 捕捉板塊輪動,提高獲利勝算

etnet榮獲HKEX Awards 2023 「最佳證券數據供應商」大獎

2025-26年度財政預算案

大國博弈

貨幣攻略

說說心理話

Watch Trends 2024

北上食買玩

Art Month 2024

理財秘笈

流感高峰期

山今養生智慧

輕鬆護老