(台耀 程正禹) 版圖再深化 台新藥 上興櫃/ 拚 乳癌 抗體-化藥Kadcyla相似藥 & 奈米眼藥clobetasol propionate (FDA phase III)

台耀生醫版圖擴張再開花，台新藥10月7日登錄興櫃 2021年10月5日 【財訊快報／記者何美如報導】台耀化學(4746)生醫版圖擴張再次開花結果，繼台康生技(6589)之後，專注眼科、腫瘤科和抗感染用藥開發的台新藥(6838)，預計10月7日登錄興櫃，登錄興櫃參考價為每股32元。台耀聚焦門檻高的原料藥，透過轉投資台新藥與台康等台字輩公司發展生物相似藥及新藥開發，一步一腳印實現台灣生技生態圈。董事長暨總經理程正禹今日表示，為了拓展生醫版圖，台耀在十年前成立台新藥，早期與台北醫學大學開發小分子抗癌藥，近年更尋找建構特殊技術平台，如奈米技術眼藥等。台新藥成立於2010年，實收資本額新台幣9.88億元，股東除了台耀持股46.63%居第一大，國內知名創投包括中華開發、中國信託創投、中租實業、工研院創新公司旗下產業躍昇基金、宏誠創投、松瑞製藥、國泰創投、萬昌創投、漢通創投、漢友集團全都在列，法人股東持股合計79%，個人股東19%，外國機構2%。台新藥專注眼科、腫瘤科和抗感染用藥開發，深化奈米技術平台與劑型設計的研發，利用專利奈米化製劑技術平台克服藥物劑型開發面臨低溶離率、生物可用率不佳等挑戰。所有研發專案中發展最快的是眼科藥物­APP13007，現已進入美國三期臨床試驗階段，其適應症為抗眼部術後發炎，主要訴求為減輕術後的發炎及疼痛反應，並且已於今年6月與中國最大的眼科藥業之一的遠大醫藥(中國)簽訂APP13007於中國、港澳地區之開發及商業化權利授權協議。另一研發重點為治療乳癌之抗體藥物複合體(Antibody-Drug Conjugate)TSY-0110，為羅氏藥廠現行上市原廠藥Kadcyla的生物相似藥，Kadcyla係治療HER2陽性乳癌之二線藥物，市場規模持續快速成長，台新藥聯合台耀化學與台康生技，以高技術障礙之抗體藥物耦合體技術平台開發，現已進入臨床前階段。執行長許力克Erick Co表示，台新藥研發能量廣袤，因應產品特性發展出生物相似藥及抗體藥物複合體，並擅長於與全球戰略夥伴合作，將多元資產整合為獨特的研發專案群，再加上與台耀化學、台康生技及其他藥廠合作組成極具實力的開發團隊，台新藥將持續增強研發實力，提升股東最大權益。

 

台耀 程正禹 再啟併購: 1.05億 台新藥 併 Activus Pharma (原料藥奈米化平台) Thursday, August 10, 2017

台耀 研發代工賺1億 難抵 轉投資臨床+台新藥合併日Activus 費用增加 Friday, January 12, 2018

 

APP13007 is a nanoparticle formulation of the corticosteroid clobetasol in development for the treatment of post-operative inflammation of the eye. Activus was originally developing APP13007 by applying its patented proprietary APNT (Activus Pure Nanoparticle Technology) to the corticosteroid clobetasol propionate to create a novel nanoparticle formulation for treating post-operative inflammation of the eye. In January 2021, Formosa Pharmaceuticals initiated a Phase III study.

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery (NCT04739709) Phase III: Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1. Willing and able to comply with study requirements and visit schedule. Provide signed and dated informed consent.

Acute Ocular Pain (AOP) Treatment People with ocular pain typically present or are referred to ophthalmologists or optometrists for evaluation. When there is recent trauma or surgery, or signs of an infectious or inflammatory process, treatment of the underlying process or pathologic abnormality usually results in resolution of pain. These situations represent physiologic or nociceptive pain. Such pain associated with surgery, injury, infection, or inflammation at the front of the eye is typically treated with a topical steroid, topical NSAID, systemic NSAID, lubricant ointment, gel or drops, bandage contact lens, or a few doses of oral opiate or topical anesthetic. Pain management and treatment options usually depend on the underlying condition. The most common ocular trauma is a superficial injury to the eye's anterior portion, such as a corneal abrasion or conjunctival laceration. Not only are these injuries excruciating, but they may not heal without intervention. An infection may ensue if not treated promptly. Therefore, it is important to refer the patient to a physician or eye care specialist quickly. Once the patient receives eye care, there are various prescription medications available to manage ocular pain and discomfort.

Acute Ocular Pain (AOP) Overview Eye pain is a myriad of symptoms ranging from a sharp pain in the eye to mild discomfort or itching in the eyes. As the spectrum of symptom presentation varies with eye pain, the cause of these pains may vary from straightforward refractive errors to potentially sight-threatening disorders like glaucoma and uveitis. A feeling of discomfort or pain in the eye can be caused by a problem in the eye itself. It can also be caused by a problem involving any structures around the eye or referred pain from tissues with similar innervation as ocular tissues. Patients with eye pain or periorbital pain frequently present to primary care physicians, neurologists, or ophthalmologists. Most ophthalmologic conditions producing ocular pains are associated with obvious ocular symptoms and signs like red-eye, photophobia, vision loss, or diplopia. Sometimes it poses a challenge to physicians when the pain is associated with a quiet eye or "white eye". Depending on where the patients experience the discomfort, eye pain can fall into one of two categories: Ocular pain occurring on the eye's surface and orbital pain within the eye. Eye pain that occurs on the surface may be scratching, burning, or itching sensation. Surface pain is usually caused by irritation from a foreign object, infection, or trauma. Often, this type of eye pain is easily treated with eye drops or rest.