Lin BioScience 仁新醫藥

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

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.....

02/07/2025

📢最新消息！News Alert

仁新醫藥今（2）日代子公司Belite Bio, Inc公告，旗下LBS-008（Tinlarebant）針對晚期乾性黃斑部病變（Geographic Atrophy）之全球臨床三期試驗（PHOENIX）已於美國、英國、法國、捷克、瑞士、中國、臺灣與澳洲等國完成500位受試者收案，將有機會成為第一個治療晚期乾性黃斑部病變之口服新藥，搶攻逾二百億美元市場商機。

Belite Bio, Inc., a subsidiary of Lin Bioscience, announced today the completion of enrollment in the Phase III PHOENIX trial, with 500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, Australia, etc. LBS-008 (Tinlarebant) has the potential to become the first oral medication for geographic atrophy (GA) in dry age-related macular degeneration (AMD), targeting a market valued at over USD 20 billion.

想瞭解更多？Read more at:
仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/79
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-completion-enrollment-pivotal-global-phase

仁新醫藥（股票代碼：6696，以下簡稱”仁新”）今（2）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）針對晚期乾性黃斑部病變（Geographic Atrophy，以下簡稱「GA」）之全....

25/06/2025

📰《2025台灣生醫女掌門人》仁新醫藥總經理王正琪博士

與仁新一起來看看董事長林雨新博士與總經理王正琪博士，如何攜手在短短不到十年內談下哥倫比亞大學、美國衛生研究院（NIH）眼睛用藥授權，並推進旗下LBS-008獲美國食品藥物管理局（FDA）對治療斯特格病變的「突破性療法」認定，以及帶領子公司Belite Bio登上納斯達克。

From vision to reality in less than a decade—Dr. Tom Lin and Dr. Irene Wang led Lin BioScience to secure licensing agreements for innovative ophthalmology drugs from Columbia University and the NIH. Their leadership advanced LBS-008 to FDA breakthrough therapy designation for the treatment of Stargardt disease and brought Belite Bio to a successful NASDAQ listing.

瞭解更多 Read more here👉https://reurl.cc/M3r89K

🎯 40人團隊挺進三期臨床、登上納斯達克！她是帶領台灣生技走進國際第一線的靈魂人物 https://reurl.cc/M3r89K
王正琪博士——仁新醫藥總經理、Belite Bio共同創辦人，不僅是《環球生技》2022年最佳CEO，更是嬌生JLABS首位獲選「傑出女性領導人」的台灣科學家！
短短不到十年，她與創業夥伴林雨新攜手，從一紙企劃書談下哥大、NIH眼藥與抗癌新藥授權，到如今LBS-008獲FDA「突破性療法」認定、子公司Belite登上納斯達克，成為史上掛牌速度最快的生技公司之一。
她怎麼做到的？
👉 堅持「一藥兩用」策略，靈活資源配置
👉 以問題為導向，打造精實文化與全球視野
👉 以身作則、親授實戰專利課，激發創新力
👉 推動教育與女性創業者成長，不藏私分享！
在快速變化的時代，她用行動證明：
「誠實、學習、共好」的領導力，正是台灣生技走向世界的最佳解答。
https://reurl.cc/M3r89K

#眼藥 #罕見疾病 #生技女力 #生醫女掌門人

23/05/2025

📰活動回顧 | 2025臺灣生醫新創CEOs高峰會

仁新醫藥總經理暨研發長王正琪博士受邀於上週五擔任《環球生技月刊》主辦的「2025臺灣生醫新創CEOs高峰會」與談人，分享了共同創辦以及成功帶領Belite Bio掛牌那斯達克的經驗與過程。在引領仁新醫藥發展的方面，強調聚焦核心、精實運作為奠定公司永續成長的基石。非常感謝主辦單位的邀請，讓我們有機會與業界先進共聚一堂，攜手推動生技產業的未來發展。

We are delighted to share that last Friday, Dr. Irene Wang, President and CSO of Lin BioScience, attended the Biotech Startup CEOs Summit hosted by Global Bio & Investment. Dr. Wang shared her experience co-founding Belite Bio and guiding it to a successful listing on Nasdaq. Now leading Lin Bioscience, Dr. Wang emphasized the importance of staying focused on core drug development as the foundation for sustainable growth. The summit provided an inspiring platform to exchange insights with visionary leaders from across the biotech industry.

瞭解更多 Read more here👉https://news.gbimonthly.com/tw/article/show.php?num=77137