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Lin BioScience 仁新醫藥

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Lin BioScience 仁新醫藥

仁新醫藥(股票代號: 6696)，為一新藥研發公司，鎖定未被滿足的醫藥需求，專注開發嶄新藥物，目前主要發展中的藥物為LBS-008（乾性黃斑部病變、斯特格病變）以及LBS-007（急性白血病、實質腫瘤）

LIN BIOSCIENCE IS A BIOTECHNOLOGY COMPANY THAT SPECIALIZES IN NEW DRUG DEVELOPMENT FOR INNOVATIVE THERAPEUTICS IN DISEASES WITH UNMET MEDICAL NEEDS. LIN BIOSCIENCE’S DIVERSE AND NOVEL PIPELINES CONSIST OF FIRST-IN-CLASS DRUG CANDIDATES AIMING TO TREAT LIFE-THREATENING OR DISABLING DISEASES IN ONCOLOGY AND OPHTHALMOLOGY INDICATIONS.
仁新醫藥是一家新藥開發公司，專注於開發創新藥物，治療未被滿足醫療需求的疾病。仁新醫藥創新及多樣的產品組合包括旨在治療危及生命的癌症及眼科疾病。公司目前共有四項新藥開發專案：LBS-008是隸屬美國國家衛生研究院神經科學研究藍圖資助計畫，用於治療乾性黃斑部病變; LBS-007是細胞分裂週期7相關蛋白激酶(CDC7)抑制劑，在動物實驗中發現可有效對抗多種癌症。公司另有兩項新藥開發專案於發現階段 (DISCOVERY STAGE)。

20/11/2025

💡仁新醫藥總經理暨研發長王正琪博士將出席「全球生命科學投資市場交流會」，並擔任座談與談人，以“Investing in Life Sciences: Risks, Opportunities and What Really Matters for Taiwanese Capital”為題，與創業投資及產業專家交流，探討產業關鍵機會與核心趨勢。

We are pleased to share that Dr. Irene Wang, President and Chief Scientific Officer of Lin BioScience, will join the Global Life Sciences Investment Exchange as a panelist. Speaking on “Investing in Life Sciences: Risks, Opportunities and What Really Matters for Taiwanese Capital,” Dr. Wang will explore industry trends and emerging opportunities with ventures and investment experts.

🌍【全球生命科學投資市場交流會】正式登場！
Global Life Sciences Investment Exchange

想掌握全球生技、製藥與醫材產業的合作交流？
GLSIX 匯聚企業、創投與產業專家，
透過專題演講、跨國Deal Room 與深度座談，
帶您洞悉台灣生醫產業接軌全球市場的新契機！

🌍 全球生醫投資趨勢解析
由 Synapto Ventures 與PwC Taiwan深入探討產業關鍵機會與核心趨勢

💡 國際 Deal Room Live 展示
來自美國、芬蘭、日本、法國、台灣、荷蘭與比利時的團隊分享

💬Panel Discussion 座談
深入剖析台灣資本布局全球生命科學產業的關鍵

👥 參加對象：投資界人士、生醫新創、科研與臨床、生命科學相關人士
📅 活動日期：11月25日（二）14:00–18:00
📍 活動地點：t.Hub內科創新育成基地－i-Stage 星創舞台開放階梯教室
📝 線上報名： https://reurl.cc/la5YYY

#生技投資 #國際交流 #生命科學

03/11/2025

🎉最新消息！News Alert

仁新醫藥於今日代子公司Belite Bio, Inc宣布，英國藥品與醫療產品監管署（MHRA）同意基於LBS-008（Tinlarebant）治療青少年斯特格病變（STGD1）臨床三期試驗DRAGON之期中分析結果，Belite可提交STGD1條件式上市許可（CMA）申請。

仁新進一步指出，在DRAGON關鍵性數據即將公布之際，先前中國NMPA即率先同意Belite可提交STGD1之NDA，並授予優先審評資格；此次英國MHRA更同意Belite可提交CMA申請，該制度允許符合未被滿足醫療需求的潛力新藥，能於完整臨床數據出爐前，先獲得上市許可的機會。

Belite Bio, Inc., a subsidiary of Lin BioScience, announced today that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

Lin BioScience further stated that, as the topline data from the Phase 3 DRAGON trial approaches, China’s NMPA had previously agreed to accept the submission of the NDA with priority review for the treatment of Stargardt disease. UK’s MHRA has now agreed to accept a CMA application, which allows promising innovative therapies addressing unmet medical needs to obtain early market access prior to completion of full clinical trials.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/84
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-uks-medicines-and-healthcare-products

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）於今日代子公司Belite Bio, Inc（那斯達克股票交易代碼：BLTE，以下簡稱”Belite”）宣布，英國藥品與醫療產品監管署（MHRA）同意基於LBS-008（Tinlarebant）治療青少年斯特格病變（STGD1....

16/10/2025

📢最新消息！News Alert

仁新醫藥於今日代子公司Belite Bio, Inc宣布，中國國家藥品監督管理局（NMPA）藥品審評中心同意基於LBS-008（Tinlarebant）治療青少年斯特格病變（STGD1）臨床三期試驗DRAGON之期中分析結果，Belite可提交STGD1新藥查驗登記申請（NDA），並授予優先審評資格。

仁新進一步指出，公司持續與全球各國主管機關保持積極溝通，而此次NMPA率先在DRAGON關鍵性數據公布前夕，就基於期中分析結果同意Belite可提交STGD1新藥查驗登記申請（NDA）並授予優先審評資格，顯示對LBS-008臨床成果及治療潛力的高度肯定。

Belite Bio, Inc., a subsidiary of Lin BioScience, announced today that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has agreed to accept the New Drug Application (NDA) with priority review for LBS-008 (Tinlarebant) for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

The company continues to engage actively with regulatory authorities worldwide. Remarkably, prior to the report of the final topline data from the Phase 3 DRAGON trial, China’s NMPA agreed to accept the submission of the NDA with priority review for the treatment of Stargardt disease based on the interim analysis results, underscoring NMPA’s high recognition of the clinical achievements and therapeutic potential of LBS-008.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/83
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-china-nmpa-agrees-new-drug-application

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）於今日代子公司Belite Bio, Inc（那斯達克股票交易代碼：BLTE，以下簡稱”Belite”）宣布，中國國家藥品監督管理局（NMPA）藥品審評中心（CDE）同意基於LBS-008（Tinlarebant）治療青少年...

15/09/2025

🎉重磅消息！News Alert

仁新醫藥於今日表示，子公司Belite Bio, Inc旗下LBS-008（Tinlarebant）口服新藥針對青少年斯特格病變（STGD1）之關鍵臨床三期試驗DRAGON，最後一位受試者已完成最後訪視，Belite預計於2025年第4季公布DRAGON頂線數據結果（Top-line results），並規劃於2026年上半年提交新藥查驗登記申請（NDA）。

Belite董事長暨執行長林雨新醫學博士表示：「我們非常高興宣布DRAGON臨床試驗順利完成。這是我們推動STGD1患者治療方案使命上的重要里程碑。由於目前尚無獲准的治療方法，LBS-008有望成為首個治療這種具威脅性的遺傳性黃斑部病變的新藥。我們衷心感謝全球的患者、家屬、研究人員及臨床團隊，讓這項臨床試驗得以實現。」

Lin BioScience announced today that its subsidiary, Belite Bio, Inc., has completed the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). Belite Bio expects to report top-line results from the DRAGON trial in Q4 2025 and plans to file New Drug Applications in the first half of 2026.

“We are very pleased to announce the successful completion of the DRAGON trial. This is an important milestone in our mission to bring a treatment to patients living with Stargardt disease,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “With no approved therapies available today, Tinlarebant has the potential to be the first treatment for this devastating inherited macular degeneration. We are deeply grateful to the patients, families, investigators, and study teams worldwide who made this clinical trial possible.”

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/82
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-completion-dragon-2-year-phase-3-trial-oral

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）於今日表示，子公司Belite Bio, Inc（那斯達克股票交易代碼：BLTE，以下簡稱”Belite”）旗下LBS-008（Tinlarebant）口服新藥針對青少年斯特格病變（STGD1）之關鍵臨床三期試驗DRAGON，最.....

09/09/2025

📢最新消息！News Alert

仁新醫藥昨（8）日代子公司Belite Bio, Inc公告，LBS-008 DRAGON試驗完成在即，Belite Bio, Inc獲RA Capital、Eventide、Marshal Wace、RTW、Soleus及Vestal Point等全球頂尖醫療生技投資機構高達2.75億美元（折合新台幣約84億元）之私募融資。此次私募由RA Capital領投，其為全球生技領域中最活躍的投資機構公司，目前旗下資產管理規模約126億美元（折合新台幣約3,836億元）。此次私募以每股64美元發行1股普通股（Ordinary Share）及1單位權證（Warrant），每單位權證履約價格更有20%溢價，高達76.8美元（折合每股約新台幣2,338元）。此次獲6家頂尖醫療生技投資機構的聯合支持，增資金額創下新高紀錄，更加彰顯出LBS-008的未來價值及Belite的發展潛力，深受國際資本市場主流生技投資人的高度認可與充分信任。

Belite Bio, Inc., a subsidiary of Lin BioScience, announced yesterday that as the LBS-008 Phase 3 DRAGON trial nears completion, the Company has entered into securities purchase agreements with leading global healthcare investors—including RA Capital Management, Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital, and Vestal Point Capital—for a private placement in public equity financing (the “PIPE”) expected to raise up to USD 275 million.

The PIPE was led by RA Capital Management, the most active investor in the global biotech sector, which currently manages assets of approximately USD 12.6 billion.
Belite Bio will issue ordinary shares and warrants to purchase the same number of ordinary shares at a purchase price of USD 64.00 per share and accompanying warrant. Each warrant will be immediately exercisable with an exercise price of USD 76.80 per ordinary share, representing a 20% premium to the purchase price.

This milestone financing, supported by six top-tier biotech investors, demonstrates both the potential of LBS-008 and Belite Bio’s long-term growth prospects, while reaffirming the confidence of leading international investors.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉https://www.linbioscience.com/TW/IM/NewsDetail/81
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-275-million-upsized-private-placement

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）昨（8）日代子公司Belite Bio, Inc（那斯達克股票交易代碼：BLTE，以下簡稱”Belite”）公告，Belite Bio, Inc與全球頂尖醫療生技投資機構RA Capital、Eventide、Marshal Wace、RTW、Soleus及Vestal Po...

08/08/2025

🎉最新消息！News Alert

仁新醫藥昨（7）日代子公司Belite Bio, Inc公告，同年再獲同一國際大型基金挹注Belite資金1,500萬美元（折合新台幣約4.5億元），以每股65美元（折合每股約新台幣1,933元）發行1股美國存託股票（ADS）及1單位權證（Warrants），每單位權證得以履約價格65美元認購1股美國存託股票。此次增資不僅進一步強化資本結構，更充分顯示LBS-008的卓越潛力與國際資本市場對其價值的高度肯定。

Belite Bio, Inc., a subsidiary of Lin BioScience, announced yesterday that it has entered into a securities purchase agreement for the purchase and sale of 230,770 American Depositary Shares (“ADSs”) and warrants to purchase 230,770 ADSs, at a purchase price of $65 per ADS and accompanying warrant, pursuant to a registered direct offering. The offering is expected to result in gross proceeds of approximately $15 million.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/80
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-registered-direct-offering-15-million-0

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）昨（7）日代子公司Belite Bio, Inc（那斯達克股票交易代碼：BLTE，以下簡稱”Belite”）公告，同年再獲同一國際大型基金挹注Belite資金1,500萬美元（折合新台幣約4.5億元），以每股65.....

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