IDEAYA and Biocytogen Receive FDA Clearance for IND Application of IDE034

Reuters12-05

IDEAYA and Biocytogen Receive FDA Clearance for IND Application of IDE034

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that its business partner, IDEAYA Biosciences, Inc., has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug $(IND)$ application for IDE034, a potential first-in-class bispecific B7H3/PTK7 antibody-drug conjugate $(ADC)$. This approval enables the initiation of a Phase 1 clinical trial, expected to begin patient enrollment in the first quarter of 2026, targeting solid tumors co-expressing B7H3 and PTK7. The IND clearance marks a significant milestone for both companies in advancing innovative cancer therapies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biocytogen Pharmaceuticals Beijing Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251205-11945437), on December 04, 2025, and is solely responsible for the information contained therein.

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ID: HKEX-EPS-20251205-11945437), on December 04, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"02315","symbol_name":"百奥赛图-B","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251204:nNDLf2bbC:1","article_id":"2589855619","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2589855619","pubTimestamp":1764892796,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Biocytogen Pharmaceuticals  Co., Ltd. announced that its business partner, IDEAYA Biosciences, Inc., has received clearance from the U.S. Food and Drug Administration  for an investigational new drug  application for IDE034, a potential first-in-class bispecific B7H3/PTK7 antibody-drug conjugate . 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Ltd. published the original content used to generate this news bri","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02315":"百奥赛图-B","BK4139":"生物科技","BK1161":"生物科技","IDYA":"IDEAYA Biosciences"},"translate_title":"IDEAYA和百奥赛图IDE034的IND申请获得FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02315":0.9,"IDYA":0.9},"content_text":"IDEAYA and Biocytogen Receive FDA Clearance for IND Application of IDE034\n    \n\n        Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that its business partner, IDEAYA Biosciences, Inc., has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug $(IND)$ application for IDE034, a potential first-in-class bispecific B7H3/PTK7 antibody-drug conjugate $(ADC)$. This approval enables the initiation of a Phase 1 clinical trial, expected to begin patient enrollment in the first quarter of 2026, targeting solid tumors co-expressing B7H3 and PTK7. The IND clearance marks a significant milestone for both companies in advancing innovative cancer therapies.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biocytogen Pharmaceuticals Beijing Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. 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