{"id":212,"date":"2023-10-30T23:11:58","date_gmt":"2023-10-30T23:11:58","guid":{"rendered":"https:\/\/accelyspharma.com\/%e3%82%a4%e3%83%b3%e3%83%99%e3%83%b3%e3%83%86%e3%82%a3%e3%83%90%e7%a4%be%e3%81%a8%e3%83%98%e3%83%91%e3%83%aa%e3%82%b9%e3%83%bb%e3%83%95%e3%82%a1%e3%83%bc%e3%83%9e%e7%a4%be%e3%80%81%e6%97%a5%e6%9c%ac\/"},"modified":"2025-06-12T14:35:57","modified_gmt":"2025-06-12T14:35:57","slug":"%e3%82%a4%e3%83%b3%e3%83%99%e3%83%b3%e3%83%86%e3%82%a3%e3%83%90%e7%a4%be%e3%81%a8%e3%83%98%e3%83%91%e3%83%aa%e3%82%b9%e3%83%bb%e3%83%95%e3%82%a1%e3%83%bc%e3%83%9e%e7%a4%be%e3%80%81%e6%97%a5%e6%9c%ac","status":"publish","type":"post","link":"https:\/\/accelyspharma.com\/ja\/%e3%82%a4%e3%83%b3%e3%83%99%e3%83%b3%e3%83%86%e3%82%a3%e3%83%90%e7%a4%be%e3%81%a8%e3%83%98%e3%83%91%e3%83%aa%e3%82%b9%e3%83%bb%e3%83%95%e3%82%a1%e3%83%bc%e3%83%9e%e7%a4%be%e3%80%81%e6%97%a5%e6%9c%ac\/","title":{"rendered":"\u3078\u30d1\u30ea\u30b9\u30d5\u30a1\u30fc\u30de\u304clanifibranor\u306b\u95a2\u3059\u308b\u65e5\u672c\u3068\u97d3\u56fd\u3067\u306e\u72ec\u5360\u7684\u958b\u767a\u30fb\u5546\u696d\u5316\u306b\u95a2\u3059\u308b\u30e9\u30a4\u30bb\u30f3\u30b9\u5951\u7d04\u3092Inventiva\u793e\u3068\u7de0\u7d50"},"content":{"rendered":"\t\t
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\u2022 Hepalys Pharma, Inc. is a new company created by Catalys Pacific and in which Inventiva has a 30% ownership position.
\u2022 Under the exclusive licensing agreement, Inventiva will receive a $10 million upfront payment, and is eligible to receive up to $ 231 million in clinical, regulatory and commercial milestone payments in addition to tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea.
\u2022 Pending regulatory approvals, Hepalys Pharma, Inc. is expected to initiate Phase I PKPD studies in Japanese patients and healthy volunteers and will be responsible for funding all studies of lanifibranor necessary to file for a new drug application in Japan and South Korea.
In addition to the 30% of shares of Hepalys Pharma, Inc., Inventiva already owns, Inventiva has the option to acquire all outstanding shares of Hepalys Pharma, Inc., at a pre-agreed multiple of post-money valuation.
\u2022 In the event Hepalys receives an offer to sell the license or rights related to lanifibranor, Inventiva has a right of first refusal.
<\/p>\n

\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u708e\uff08NASH\uff09\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u30a2\u30f3\u30e1\u30c3\u30c8\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb<\/strong>\u30cb\u30fc\u30ba\u306e\u9ad8\u3044\u75be\u60a3\u306b\u5bfe\u3059\u308b\u7d4c\u53e3\u4f4e\u5206\u5b50\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u6ce8\u529b\u3059\u308b\u81e8\u5e8a\u6bb5\u968e\u306e\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u4f01\u696d\u3067\u3042\u308b\u30a4\u30f3\u30d9\u30f3\u30c6\u30a3\u30d0\u793e\uff08Euronext Paris and Nasdaq: IVA\uff09\u3068\u30d8\u30d1\u30ea\u30b9\u30d5\u30a1\u30fc\u30de\u793e\uff08Hepalys Pharma, Inc\u3001\u3068\u306e\u9593\u3067\u3001\u30a4\u30f3\u30d9\u30f3\u30c6\u30a3\u30d0\u793e\u304c\u72ec\u81ea\u306b\u958b\u767a\u3057\u305f\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u708e\uff08NASH\uff09\u6cbb\u7642\u85ac\u30e9\u30cb\u30d5\u30a3\u30d6\u30e9\u30ce\u30fc\u30eb\u306e\u65e5\u672c\u304a\u3088\u3073\u97d3\u56fd\u306b\u304a\u3051\u308b\u72ec\u5360\u7684\u30e9\u30a4\u30bb\u30f3\u30b9\u5951\u7d04\uff08\u4ee5\u4e0b\u300c\u672c\u5951\u7d04\u300d\uff09\u3092\u7de0\u7d50\u3057\u307e\u3057\u305f\u3002<\/p>\n

Hepalys Pharma is a new company founded by Catalys Pacific, an investment firm specialized in creating and financing venture capital-backed biopharmaceutical companies to develop pharmaceutical products in Asia. Hepalys Pharma is backed by renowned investors including Catalys Pacific, Mitsubishi UFJ Capital, DBJ Capital, and MEDIPAL Innovation Fund. <\/p>\n

In parallel of the incorporation of Hepalys Pharma, Inventiva has exercised its right to own 30% of the company.<\/p>\n

Under the terms of this licensing agreement, Inventiva will receive a $10 million upfront payment from Hepalys Pharma and will be eligible to receive up to $231 million in milestone payments if certain clinical, regulatory and commercial conditions are met. Subject to regulatory approval, Inventiva has the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea. <\/p>\n

In addition, under the terms of this agreement, Inventiva has the option to acquire the outstanding shares of Hepalys Pharma at a pre-agreed multiple of post-money valuation under certain conditions, and has a right of first refusal if Hepalys Pharma, Inc. receives an offer to sell the license and rights related to lanifibranor.<\/p>\n

This agreement is expected to accelerate the time to market of lanifibranor in Japan and South Korea if regulatory approvals are obtained. Both countries are major markets, with up to 2.7%1 of and up to 5.2%2 of Japanese and South Koreans, respectively, suffering from NASH, including about 15% of South Korean patients with significant fibrosis. Hepalys Pharma, Inc. is expected to start the clinical development of lanifibranor by conducting two phase I studies in Japanese patients and healthy volunteers. It is anticipated that these studies would support, if positive, the initiation of a dedicated pivotal trial in Japanese and Korean patients with NASH, which is planned to start once the results of NATiV3, the pivotal phase III trial currently conducted by Inventiva, are available. Hepalys Pharma, Inc. will be responsible for conducting and financing all development trials in Japan and South Korea needed to file for a new drug application in these territories. <\/p>\n

Frederic Cren, CEO and cofounder of Inventiva, stated:<\/strong> \u201cWe are thrilled to further expand our global reach to Japan and South Korea through this exclusive licensing agreement with Hepalys Pharma, Inc. We strongly believe that Hepalys Pharma, Inc. with its experienced team is the right partner to start and fund the clinical development of lanifibranor in Japan and South Korea. This agreement is a great opportunity for Inventiva to speed up the potential commercialization of its lead asset in these two major markets and diversify our milestones and royalties\u2019 source of revenues if regulatory approvals are achieved. With the ongoing partnership in Greater China and this new agreement in Japan and Korea, Inventiva is eligible to receive up to an additional $519M of clinical, regulatory and commercial milestones.\u201d<\/p>\n

BT Slingsby, MD, PhD, MPH, Representative Director of Hepalys Pharma, Inc., stated:<\/strong> \u201cWe are delighted to enter into a licensing agreement with Inventiva. We purposely founded Hepalys Pharma, Inc. to conduct the clinical development and potential commercialization of lanifibranor, a drug candidate for the potential treatment of NASH in Japan and Korea. We are confident that, if successful in our clinical programs and if required regulatory approvals are obtained, lanifibranor could potentially become an effective treatment for patients with NASH in Japan and South Korea based on the efficacy demonstrated so far on fibrosis and NASH resolution, and on the cardiometabolic components of the disease. We are looking forward to starting the clinical development program of lanifibranor in Japan and South Korea.\u201d<\/p>\n

About Hepalys Pharma, Inc.<\/strong><\/p>\n

Hepalys Pharma, Inc. is a private venture-backed biopharmaceutical company focused on the development of novel therapeutics for liver disease, led by a world-class team and a transpacific clinical advisory board, committed to develop and commercialize lanifibranor and potentially other compounds for patients in Asian countries. Hepalys is headquartered in Tokyo, Japan. <\/p>\n

About Catalys Pacific<\/strong><\/p>\n

Catalys Pacific is a life sciences venture capital firm whose mission is to provide healthcare solutions for patients worldwide through the creation of, and investment in biotech companies. Catalys Pacific is led by a global team versed in working closely with its partners in academia, biotech, venture capital and the pharmaceutical industry worldwide with an emphasis in Japan. The firm maintains offices in Tokyo, Japan and in San Francisco, California. <\/p>\n

\u30e9\u30cb\u30d5\u30a3\u30d6\u30e9\u30ca\u30fc\u306b\u3064\u3044\u3066<\/strong><\/p>\n

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\u30a4\u30f3\u30d9\u30f3\u30c6\u30a3\u30d0\u306b\u3064\u3044\u3066<\/strong><\/p>\n

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\u30a4\u30f3\u30d9\u30f3\u30c6\u30a3\u30d0\u306f\u3001\u30e6\u30fc\u30ed\u30cd\u30af\u30b9\u30c8\u30fb\u30d1\u30ea\u306e\u898f\u5236\u5e02\u5834\u30b3\u30f3\u30d1\u30fc\u30c8\u30e1\u30f3\u30c8B\uff08\u30c6\u30a3\u30c3\u30ab\u30fc\uff1aIVA\u3001ISIN\uff1aFR0013233012\uff09\u304a\u3088\u3073\u7c73\u56fd\u306e\u30ca\u30b9\u30c0\u30c3\u30af\u30fb\u30b0\u30ed\u30fc\u30d0\u30eb\u30fb\u30de\u30fc\u30b1\u30c3\u30c8\uff08\u30c6\u30a3\u30c3\u30ab\u30fc\uff1aIVA\uff09\u306b\u4e0a\u5834\u3057\u3066\u3044\u308b\u516c\u958b\u4f01\u696d\u3067\u3059\u3002www.inventivapharma.com\u3002 <\/p>\n

<\/p>\n

\u9023\u7d61\u5148<\/strong><\/p>\n

Inventiva<\/strong>
Pascaline Clerc
\u30b0\u30ed\u30fc\u30d0\u30eb\u6e09\u5916\u62c5\u5f53\u526f\u793e\u9577
media@inventivapharma.com<\/a>
+1 240 620 9175<\/p>\n

Brunswick Group<\/strong>
Tristan Roquet Montegon \/
Aude Lepreux \/
Matthieu Benoist
Media relations
inventiva@brunswickgroup.com<\/a>
+33 1 53 96 83 83<\/p>\n

Westwicke, an ICR Company<\/strong>
Patricia L. Bank
Investor relations
patti.bank@westwicke.com<\/a>
+1 415 513-1284<\/p>\n

\u91cd\u8981\u306a\u304a\u77e5\u3089\u305b<\/strong><\/p>\n

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Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly 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898b\u901a\u3057\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u3001\u4e88\u6e2c\u304a\u3088\u3073\u4e88\u60f3\u306f\u3001\u672c\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306e\u65e5\u4ed8\u73fe\u5728\u306b\u304a\u3051\u308b\u3082\u306e\u3067\u3059\u3002\u8aad\u8005\u306e\u7686\u69d8\u306f\u3001\u3053\u308c\u3089\u306e\u5c06\u6765\u4e88\u60f3\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u3092\u904e\u5ea6\u306b\u4fe1\u983c\u3057\u306a\u3044\u3088\u3046\u3054\u6ce8\u610f\u304f\u3060\u3055\u3044\u3002 <\/p>\n

\u30ea\u30b9\u30af\u8981\u56e0\u300d\u306e\u898b\u51fa\u3057\u306e\u4e0b\u306b\u968f\u6642\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u3092\u542b\u3081\u3001\u30a4\u30f3\u30f4\u30a7\u30f3\u30c6\u30a3\u30d0\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u305d\u306e\u4ed6\u306e\u30ea\u30b9\u30af\u304a\u3088\u3073\u4e0d\u78ba\u5b9f\u6027\u306b\u3064\u3044\u3066\u306f\u30012023\u5e743\u670830\u65e5\u306b\u91d1\u878d\u5546\u54c1\u53d6\u5f15\u5e81\u306b\u63d0\u51fa\u3055\u308c\u305f2022\u5e7412\u670831\u65e5\u306b\u7d42\u4e86\u3059\u308b\u5e74\u5ea6\u306e\u5e74\u6b21\u767b\u9332\u66f8\u985e\u3001\u304a\u3088\u30732023\u5e743\u670830\u65e5\u306b\u8a3c\u5238\u53d6\u5f15\u59d4\u54e1\u4f1a\u306b\u63d0\u51fa\u3055\u308c\u305f2022\u5e7412\u670831\u65e5\u306b\u7d42\u4e86\u3059\u308b\u5e74\u5ea6\u306e\u5e74\u6b21\u5831\u544a\u66f8\uff08\u30d5\u30a9\u30fc\u30e020-F\uff09\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002\u30a4\u30f3\u30f4\u30a7\u30f3\u30c6\u30a3\u30d0\u304c\u73fe\u5728\u8a8d\u8b58\u3057\u3066\u3044\u306a\u3044\u305d\u306e\u4ed6\u306e\u30ea\u30b9\u30af\u3084\u4e0d\u78ba\u5b9f\u6027\u3082\u3001\u5c06\u6765\u4e88\u6e2c\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u5b9f\u969b\u306e\u7d50\u679c\u3084\u4e8b\u8c61\u306e\u767a\u751f\u6642\u671f\u304c\u4e88\u6e2c\u3055\u308c\u305f\u3082\u306e\u3068\u5927\u304d\u304f\u7570\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n

\u672c\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u60c5\u5831\u306f\u3059\u3079\u3066\u30ea\u30ea\u30fc\u30b9\u65e5\u73fe\u5728\u306e\u3082\u306e\u3067\u3059\u3002\u6cd5\u5f8b\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u5834\u5408\u3092\u9664\u304d\u3001\u30a4\u30f3\u30f4\u30a7\u30f3\u30c6\u30a3\u30d0\u306f\u4e0a\u8a18\u306e\u5c06\u6765\u4e88\u60f3\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u3092\u66f4\u65b0\u307e\u305f\u306f\u898b\u76f4\u3059\u610f\u56f3\u3092\u6301\u305f\u305a\u3001\u305d\u306e\u7fa9\u52d9\u3092\u8ca0\u3044\u307e\u305b\u3093\u3002\u5f93\u3063\u3066\u3001\u30a4\u30f3\u30f4\u30a7\u30f3\u30c6\u30a3\u30d0\u306f\u3001\u4e0a\u8a18\u306e\u8a18\u8ff0\u306e\u4f7f\u7528\u304b\u3089\u751f\u3058\u308b\u3044\u304b\u306a\u308b\u7d50\u679c\u306b\u5bfe\u3057\u3066\u3082\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u305b\u3093\u3002 <\/p>\n

\u65e5\u672c\u306b\u304a\u3051\u308b\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u75be\u60a3\u304a\u3088\u3073\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u708e\u306e\u75ab\u5b66\uff1a\u65e5\u672c\u306b\u304a\u3051\u308b\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u75be\u60a3\u304a\u3088\u3073\u975e\u30a2\u30eb\u30b3\u30fc\u30eb\u6027\u8102\u80aa\u6027\u809d\u708e\u306e\u75ab\u5b66\uff1a\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3002JGH Open.2020 May 5;4(5):808-817.
2Park J, Lee EY, Li J, Jun MJ, Yoon E, Ahn SB, Liu C, Yang H, Rui F, Zou B, Henry L, Lee DH, Jun DW, Cheung RC, Nguyen MH.NAFLD\u60a3\u8005\u306b\u304a\u3051\u308bNASH\/\u809d\u7dda\u7dad\u75c7\u306e\u6709\u75c5\u7387\u3068\u809d\u81d3\u4ee5\u5916\u306e\u5408\u4f75\u75c7\u306e\u767a\u751f\u7387\u3001\u304a\u3088\u3073\u4ee3\u8b1d\u6027\u5408\u4f75\u75c7\u5225\u306eNAFLD\u306e\u767a\u751f\u7387\uff1a\u97d3\u56fd\u304b\u3089\u306e\u6559\u8a13\u3002Dig Dis.2021;39(6):634-645. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

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