Lin BioScience 仁新醫藥

24/04/2026

📰活動回顧 | 臺北醫學大學 雙和產業鏈結專題講座

仁新醫藥總經理暨研發長王正琪博士受邀於本週三擔任臺北醫學大學醫學科技學院主辦的「雙和產業鏈結專題講座」擔任主講者，分享了仁新集團的企業願景、研發結果，以及於生技產業的實務經驗。感謝主辦單位的邀請，讓我們有機會與臺北醫學大學的師生交流，為未來產學合作開啟更多可能性。

We are delighted to share that this Wednesday, Dr. Irene Wang, President and Chief Scientific Officer of Lin BioScience, was invited to speak at the “Industry-Academia Talk” hosted by Taipei Medical University. During the session, Dr. Wang shared the company’s strategic vision, R&D progress, and experience in the biotechnology industry.

We appreciate the invitation and the opportunity to engage with Taipei Medical University faculty and students, and to foster meaningful exchange.

22/04/2026

📰活動回顧 | 澳洲辦事處 - 台灣醫療界女性領袖晚宴

仁新醫藥總經理暨研發長王正琪博士受邀於本週一與澳洲辦事處馮國斌代表、墨爾本大學彼得杜赫提感染與免疫研究所主任Sharon Lewin教授，以及多位台灣醫療界的傑出女性領袖共進晚餐。

感謝馮國斌代表的盛情邀請與交流機會，期待未來持續台灣與澳洲的合作契機！

We are pleased to share that, Dr. Irene Wang, President and Chief Scientific Officer of Lin BioScience, was honored to attend a dinner this Monday with Representative Fergusson, Professor Sharon Lewin AO, Director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne, and a distinguished group of Taiwanese women leaders in health.

We sincerely appreciate Representative Fergusson’s warm invitation and thoughtful arrangements, which made this meaningful exchange possible. We look forward to further strengthening collaboration between Taiwan and Australia in healthcare and biotechnology!

❤️‍🩹「昨晚很榮幸與一群傑出的台灣醫療界女性領袖，以及我們的特別來賓：墨爾本大學彼得杜赫提感染與免疫研究所主任Sharon Lewin教授，共進晚餐、度過一場精彩的交流盛宴。期待澳洲與台灣有更多的合作契機！」- 馮國斌代表

❤️‍🩹‘A really wonderful dinner last night with an impressive group of Taiwanese female health leaders and our special visitor, Professor Sharon Lewin AO, Director of the Peter Doherty Institute for Infection and Immunity, University of Melbourne! Lots of information sharing and opportunities for future collaboration.’ - Representative Fergusson

The Peter Doherty Institute for Infection and Immunity
The University of Melbourne

22/04/2026

🎉最新消息！News Alert

仁新醫藥於今日代子公司Belite Bio, Inc公告，Belite已正式向美國FDA提出治療斯特格病變新藥LBS-008（Tinlarebant）之新藥查驗登記申請（NDA）滾動式送件程序。

受惠於FDA針對斯特格病變所授予之突破性治療認定（Breakthrough Therapy Designation），Belite展開新藥查驗登記申請滾動式送件程序，藉此加速審查時程。此送件機制賦予Belite分階段提交新藥申請文件，FDA得以提前啟動審查程序，打破了傳統新藥查驗登記申請需要一次性備齊文件始得送件的限制。Belite預計於2026年第二季完成所有資料送件，力拚成為全球首款獲准之斯特格病變新藥。

仁新表示，斯特格病變目前並無任何藥物或療法，Belite憑藉先前取得之突破性治療認定，利用滾動式審查優勢來縮短藥物上市的時間。Tinlarebant為全球首款在斯特格病變治療領域取得重大突破的候選藥物，本次啟動新藥查驗登記申請滾動式送件程序，不僅是全球新藥開發的重要里程碑，更象徵該藥物正式邁入關鍵的新藥上市監管審查階段。未來Belite將持續推動全球新藥開發進程，加速商業化布局，期盼在為患者提供創新療法的同時，持續為股東創造長期價值。

Belite Bio, Inc., a subsidiary of Lin Bioscience, today announced that it has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tinlarebant.

Supported by the FDA’s Breakthrough Therapy Designation for STGD1, Belite has commenced the rolling submission of its NDA to expedite the review workflow. This approach allows the company to submit application materials in stages, enabling the FDA to initiate its review in advance, rather than waiting for a complete submission as required under the conventional NDA process. The company expects to complete the NDA rolling submission in the second quarter of 2026 and is striving to become the first approved treatment worldwide for Stargardt disease.

Lin BioScience stated that no therapies are currently available for Stargardt disease. Building on the Breakthrough Therapy Designation, Belite is leveraging the rolling review pathway to shorten time to market. Tinlarebant, as a first-in-class candidate demonstrating significant progress in this field, marks an important milestone with the initiation of the NDA rolling submission, signifying its entry into a critical stage of regulatory review. Belite will continue to advance its global development programs and accelerate commercialization efforts, with the goal of delivering innovative therapies to patients while creating long-term value for shareholders.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/88
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-initiates-rolling-submission-new-drug-application-us

21/04/2026

在醫學研究持續進步的今天，急性骨髓性白血病仍是高度未被滿足醫療需求的疾病。4月21日為世界急性骨髓性白血病日，讓我們一同來認識這項疾病。

急骨髓性白血病（Acute myeloid leukemia，簡稱AML）是一種骨髓性造血芽細胞異常增殖的血液惡性腫瘤，是成年人最常見的急性白血病，其發病率隨著人的年齡而增加。在現行標準治療下，白血病的5年存活率約為60%；而成人的及急性骨髓性白血病存活率只有25%。

仁新醫藥致力研發創新抗癌標靶藥物LBS-007，繼2024年底獲得美國FDA急性骨髓性白血病之治療快速審查認定（Fast Track Designation），及澳洲開展首次應用於人體的第一/二期臨床試驗。於2024年10月以及2025年9月分別得到美國FDA 新藥臨床申請（IND）和中國國家藥品監督管理局藥品審評中心（NMPA）核准在中國與美國進行急性白血病之第一/二期臨床試驗。我們正全力推動為白血病患者帶來突破性的治療選擇，為高度未被滿足醫療需求的疾病帶來一線曙光。

Today is World AML Awareness Day. While leukemia treatments have advanced, Acute Myeloid Leukemia (AML) remains a critical challenge. For adults, the five-year survival rate is just 25%. A clear reminder of the urgent need for new therapeutic options.

At Lin BioScience, we are working to change this reality. We are rapidly advancing LBS-007, our novel targeted oncology therapy designed for patients facing high unmet medical needs. Backed by U.S. FDA Fast Track Designation, our global clinical development is accelerating, with Phase I/II trials now actively ongoing across Australia, the United States, and China.

We remain deeply committed to delivering breakthrough treatments to the patients who need them most.

瞭解仁新醫藥如何對抗AML👉
https://www.linbioscience.com/TW/Pipeline/LBS007
Learn how Lin BioScience battles AML👉 https://www.linbioscience.com/pipeline/lbs007

30/01/2026

📢最新消息！News Alert

仁新醫藥於27日代子公司Belite Bio, Inc公告，旗下LBS-008（Tinlarebant）針對青少年斯特格病變（STGD1）之DRAGON II第二／三期臨床試驗已於日本、美國及英國完成60位受試者收案，其中有15位為日本人受試者，日本受試者數據將有助於未來在日本的新藥上市申請及後續商業化安排。Belite並規劃於2026年上半年先向美國FDA遞交新藥上市申請（NDA）。

仁新表示，LBS-008為全球首款證實具STGD1臨床療效之治療候選藥物，其在關鍵的DRAGON臨床三期試驗解盲數據亮眼，主要療效指標顯示病灶增長速度降低了36%（p=0.0033），展現LBS-008在罕病眼疾治療領域之潛力。隨著DRAGON解盲成功，Belite將以最高效率推動新藥上市與後續全球市場佈局，讓臨床成果真正轉化為實際市場價值。

Belite Bio, Inc., a subsidiary of Lin Bioscience, announced on January 27 the completion of enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). Across Japan, the United States, and the United Kingdom, the trial had a targeted enrollment of 60 adolescent subjects, including 15 Japanese subjects, whose data are expected to support future new drug application efforts and subsequent commercialization in Japan. Belite Bio plans to file its first NDA with the US FDA in 1H 2026.

Lin BioScience stated that LBS-008 is the world’s first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease type 1 (STGD1), with compelling topline results from the pivotal Phase 3 DRAGON clinical trial showing a 36% reduction in lesion growth rate on the primary efficacy endpoint (p = 0.0033), highlighting the strong potential of LBS-008 in the treatment of rare retinal diseases. Belite Bio is positioned to efficiently advance the regulatory submissions and global commercialization strategies, aiming to transform its clinical achievements into tangible market value.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/87
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-completes-enrollment-dragon-ii-clinical-trial

仁新醫藥（股票代碼：6696，以下簡稱”仁新”） 昨（27）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，旗下LBS-008（Tinlarebant）針對青少年斯特格病變（STGD1）之DRAGON II第二／三期臨床試驗已.....

05/12/2025

📰活動回顧 | 倍利投資論壇、2025 富邦生技產業企業日

仁新醫藥總經理暨研發長王正琪博士受邀於本週二及週五擔任「倍利投資論壇」及「2025 富邦生技產業企業日」與談人，分享了仁新集團企業願景、研發結果，更於週五「2025 富邦生技產業企業日」分析子公司Belite Bio臨床三期數據。感謝主辦單位的邀請，讓我們有機會與投資先進交流。

We are pleased to share that, Dr. Irene Wang, President and Chief Scientific Officer of Lin BioScience, participated the Beiley Biofund Investor Conference on Tuesday and the 2025 Fubon Biotech Corporate Day on Friday. Dr. Wang highlighted the company’s strategic vision and provided a detailed presentation of the recently released Phase 3 topline data from our subsidiary, Belite Bio, during the Fubon Biotech Corporate Day. We appreciate the organizers for fostering meaningful exchanges with the investors.

倍利投資論壇照片來源：環球生技多媒體股份有限公司 李林娜

02/12/2025

📢最新消息！News Alert

仁新醫藥今日代子公司Belite Bio, Inc公告，於美東時間12月1日成功完成一輪公開發行現金增資。本次增資之每股發行價格為154美元（折合每股約新台幣4,829元），除發行2,272,727股美國存託股票，募得約3.5億美元（折合新台幣約110億元）外，Belite同時授予承銷商超額配售權利，於承銷合約簽訂之日起30日內得以相同發行價格追加認購上限達340,909股之美國存託股票。若超額配售權利獲承銷商全數執行，總募集金額將提高至4.025億美元（折合新台幣約126億元）。

仁新表示，Belite今年已完成多次巨額募資，且募資規模屢創新高。此次更在Dragon解盲不到12小時內，以Belite美東時間12月1日之收盤價（不折價）發行，當日迅速完成上限高達4.025億美元的現金增資，再次刷新紀錄，顯示Tinlarebant解盲之關鍵性數據非常亮眼，深獲美國資本市場強力買單，也展現Tinlarebant在罕病眼疾治療領域之潛力及其市場前景不容小覷。本次募資象徵商業化準備已揭開序幕，隨著Tinlarebant解盲成功，Belite將以最高效率推動新藥上市與後續全球市場佈局，讓臨床成果真正轉化為實際市場價值。

Belite Bio, Inc., a subsidiary of Lin BioScience, announced today that it has priced an underwritten public offering of 2,272,727 American Depositary Shares (“ADSs”), each representing one of its ordinary shares, at a public offering price of $154.00 per ADS. The Company has also granted the underwriters a 30-day option to purchase up to 340,909 additional ADSs from the Company at the public offering price, less underwriting discounts and commissions. The gross proceeds of the offering to the Company are expected to be approximately $350.0 million before deducting underwriting discounts and commissions and offering expenses payable by Belite Bio. If the underwriters fully exercise the over-allotment option, the total gross proceeds would increase to approximately $402.5 million.

Lin BioScience stated that, Belite has secured several major financings this year, each setting new fundraising milestones. Remarkably, within just 12 hours of the Dragon data readout, Belite completed this offering at its December 1 U.S. closing price without any discount, reaching the maximum amount of US$402.5 million. The strong demand underscores the strength of Tinlarebant’s pivotal data and its compelling commercial outlook. This fundraising marks the beginning of Belite’s commercialization preparation. Following the successful readout of Tinlarebant, the company will accelerate its regulatory, commercial, and global market strategies to convert its clinical achievements into tangible market value.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/86
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-pricing-3500-million-underwritten-public

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）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”）公告，於美東時間12月1日成功完成一輪公開發行現金增資。本次增資之每股發行價格為154美元（折合....

02/12/2025

🎉重磅消息！News Alert

仁新醫藥於昨日代子公司Belite Bio, Inc公告，旗下LBS-008（Tinlarebant）口服新藥針對青少年斯特格病變臨床三期試驗（DRAGON）解盲之關鍵性數據（Top-line data），成為有史以來首次成功的斯特格病變關鍵性試驗。斯特格病變是一種會逐漸奪走視力、最終可能失明的遺傳性眼疾，目前全球尚無已核准的治療方法。Belite規劃於2026年上半年向美國FDA遞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：「DRAGON最終試驗結果讓斯特格病變疾病治療迎來了歷史性突破，Tinlarebant將成為首個治療這種具威脅性疾病的潛在新藥，並帶給長期面對這種過去被認為無藥可醫疾病的患者及其家屬治療新希望。」

Belite醫務長Hendrik Scholl醫學博士表示：「口服療法可以改變斯特格病變的病程，DRAGON提供了至今最強而有力的證據。結果驗證了Tinlarebant的作用機轉，能有效減緩疾病進程。整體而言，這些數據進一步強化了Tinlarebant改變斯特格病變治療格局的潛力。」

仁新表示，Tinlarebant是全球市場首見藥物（first-in-class）。仁新集團是全球第一個在斯特格病變做到突破的團隊，也是歐美以外第一家成功開發出全新機轉新藥的公司，在無藥可醫的領域寫下歷史性里程碑。

Belite Bio, Inc., a subsidiary of Lin BioScience, yesterday announced topline results from the global Phase 3 “DRAGON” trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood or young adulthood, and currently has no approved treatment worldwide. Belite Bio plans to file an NDA with the US FDA in 1H 2026.

“The final results from the DRAGON trial mark a historic breakthrough in Stargardt disease, paving the way for the first potential treatment for this devastating condition and bringing new hope to patients and families who have long faced a disease once considered untreatable,” said Dr. Tom Lin, Chairman and CEO of Belite Bio.

“The DRAGON trial delivers the most compelling evidence to date that an oral therapy can alter the course of Stargardt disease,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. “These results validate the scientific approach behind Tinlarebant’s development, demonstrating that reducing the accumulation of toxic byproducts in the retina can meaningfully slow disease progression. Collectively, these data reinforce Tinlarebant’s potential to change the treatment landscape for Stargardt disease.”

Lin BioScience further stated that Tinlarebant represents a first-in-class therapy on the global market. Lin BioScience corporation is the first team in the world to achieve a breakthrough in Stargardt disease — and the first company beyond the US and Europe to successfully develop a therapy with a novel mechanism, marking a historic milestone in an indication where no available treatment exists.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/85
Belite Bio News Release Details👉https://investors.belitebio.com/news-releases/news-release-details/new-hope-people-living-disease-once-deemed-untreatable-belite

🔴 Today, Belite Bio shared positive topline results from the pivotal Phase 3 DRAGON trial evaluating Tinlarebant in adolescents with Stargardt disease, reflecting meaningful progress in the development of a potential treatment for this condition.

Highlights include:

- 36% reduction in lesion growth vs placebo (p=0.0033)
- First therapeutic candidate to demonstrate efficacy in a global Phase 3 trial in Stargardt disease
- Favorable safety and tolerability profile over 24 months

We extend our deepest gratitude to the patients, families, caregivers, and investigators whose participation and commitment made this milestone possible.

Join our conference call to learn more: https://events.q4inc.com/attendee/851809284

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

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👥 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
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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.

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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...