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10/30 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
PharmaEssentia Completes Enrollment for ET New Drug Phase III Clinical Trial
26 October, 2023
PharmaEssentia (TW: 6446) has announced the completion of patient enrollment in the global, multi-country, multi-center Phase III clinical trial for its new drug, Ropeginterferon alfa-2b (referred to as Ropeg or P1101), for the treatment of Essential Thrombocythemia (ET). This Phase III clinical trial, known as "SURPASS ET," is expected to collect key efficacy data by 2024. Subsequently, the company plans to submit applications for ET drug approvals in several countries, including Taiwan, the United States, Japan, South Korea, and China, marking a potential second engine for PharmaEssentia's business growth acceleration.

Ropeg is an innovative long-acting interferon developed and produced by PharmaEssentia, already approved for use in adult patients with Polycythemia Vera (PV) in various countries, including major global pharmaceutical markets in Europe, the United States, and Japan. More... (in Chinese)
Progress in New Drug Development: Lin BioScience Applies for Phase I Clinical Trials in Australia, Oneness Biotech to Enter Thai Market
25 October, 2023
Progress has been made in the development of new drugs by Taiwanese biotech companies. RBP4 Pty, a subsidiary of Lin BioScience (TW: 6696), has applied for a Phase I clinical trial in Australia to assess the impact of food on healthy adult subjects and drug interactions for their new drug, LBS-008. And Oneness Biotech (TW: 4743), through its subsidiary has submitted a registration application to the Thailand Food and Drug Administration for its wound ointment, Bonvadis. More... (in Chinese)
Wong Chi-Huey Develops Low-Sugar Vaccine, Selected as One of the Top 10 Emerging Technologies in International Chemistry
24 October, 2023
Wong Chi-Huey, the former president of Academia Sinica, led a team to develop a unique low-sugar broad-spectrum vaccine technology. This achievement has been selected as one of the top ten emerging technologies in the field of chemistry by the International Union of Pure and Applied Chemistry (IUPAC) for this year. This marks the first time that a Taiwanese research achievement has been chosen. More... (in Chinese)
Foresee Pharmaceuticals' Breast Cancer Drug Phase III Clinical Trial Application Accepted in China
24 October, 2023
Foresee Pharmaceuticals (TW: 6576) announced that the application for a Phase III clinical trial of the improved drug FP-001 42mg for the treatment of premenopausal breast cancer has received a notification of acceptance from the National Medical Products Administration (NMPA) in China, and has entered the substantive review stage. After conducting the Phase III clinical trial, the company intends to submit a new drug registration application. More... (in Chinese)
NTU team devises way to target alcohol addiction
24 October, 2023
National Taiwan University (NTU) yesterday said a research team, in collaboration with researchers from Taichung Veterans General Hospital and a US medical equipment manufacturer, developed a noninvasive radiosurgery system that has shown potential for treating alcohol addiction in animal experiments More...
Tri-Service General Hospital unveils Center for Cell Therapy and Regenerative Medicine
20 October, 2023
The Centre for Cell Therapy and Regenerative Medicine of the Tri-Service General Hospital was launched on 20 October. Dr Yi-Jen Hung, Superintendent of the hospital, said that in the future it will support the development of national policies, become a regenerative medicine incubator, create a platform for sharing regenerative medicine resources and promote the development of Taiwan's regenerative medicine industry. More...
Senhwa Biosciences Announces IND Submission to US FDA for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection
Press release
19 October, 2023
Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that it has submitted an Investigational New Drug (IND) application to U.S. Food and Drug Administration to evaluate its investigational drug, Silmitasertib(CX-4945), for treating patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses. More...
Qisda the first in Taiwan receives MDR certification for its medical ultrasound products
19 October, 2023
Qisda Group has announced that its medical ultrasound products have received EU Medical Device Regulation (MDR) certification within one year, making it the first company in Taiwan to receive MDR for medical ultrasound, demonstrating the quality of its medical ultrasound products in compliance with the strictest EU regulations and, most importantly, gaining access to the EU market. More...
Amgen Taiwan's Visionary Leap: Uniting Workforce and Strategy for a Glorious Future
17 October, 2023
In the realm of healthcare, standing out hinges on the ability to push boundaries while steadfastly upholding a commitment to serving patients. For California-based biopharmaceutical company Amgen, being a frontrunner is not a mere aspiration – it's ingrained in the very fabric of the organization. The company has been bringing groundbreaking contributions to the world of medicine for over four decades. More...
VeriSee DR by Acer Medical increases adoption by Thai hospitals
17 October, 2023
VeriSee DR, developed by Acer Medical, has been introduced into more than 10 hospitals in Thailand, and has successfully established strategic partnerships with local upstream and downstream vendors in the healthcare industry. More...
Precision Medicine Forum Gathers Experts to Pioneer Taiwan's Personalized Cancer Care
17 October, 2023
Malignant tumors have consistently ranked as the leading cause of death in Taiwan for 40 straight years. In 2020, for example, the cancer incidence rate in Taiwan reached 311.3 per 100,000 population, with specific types like breast and colorectal cancers increasing among younger populations. This trend underscores the urgent need for precise and personalized cancer care, aiming to enable early detection and optimize treatment outcomes. More...
Taiwan Biotech Companies Report Progress in Developing Improved New Drugs
16 October, 2023
A number of Taiwanese biotech companies report significant progress in the development of improved and new drugs, securing licenses for eight products. Of these four of them are focusing on 505(b)(2) 'improved' drugs, highlighting the diversified strategies of Taiwan's biotech companies. In addition to developing generic drugs and new medications, the progress in new drug application development is proving to be fruitful, with comparable value to developing novel drugs. More... (in Chinese)
AP Biosciences Eyes Medication Licensing
16 October, 2023
OBI Pharma has a reason to celebrate with the licensing of a new medication from its subsidiary AP Biosciences. In a recent announcement the company reported that it had completed enrollment of the first subject in the Phase III clinical trial for the new drug IBI302, designed to treat wet age-related macular degeneration. If the drug successfully enters the market in the future, it will come with milestone payments and revenue sharing. More... (in Chinese)
Medigen Biotechnology Releases Phase II Clinical Data for New Drug OBP-301, Plans to Apply for Drug Certification in the Second Half of 2024
16 October, 2023
Medigen Biotechnology (TW: 3176) and the Japanese publicly traded company Oncolys BioPharma (Tokyo Stock Exchange symbol 4588) have jointly developed the oncolytic virus new drug OBP-301 (Telomelysin). Oncolys announced that the Phase II clinical trial of OBP-301 combined with radiation therapy for esophageal cancer conducted in Japan has achieved a primary efficacy endpoint, the 'Local Complete Response Rate' (L-CR), exceeding the threshold set in the clinical trial protocol, demonstrating the effectiveness of OBP-301 for locally advanced esophageal cancer. It is expected that they will apply for drug certification in the second half of 2024. More... (in Chinese)
Diamond Biofund Invests NTD120 Million in Syncell
16 October, 2023
Diamond Biofund (TW: 6901) announced that it is investing USD4 million (approximately NTD128 million) in Syncell to support the mass production of domestic high-end precision instruments for international markets. Syncell successfully raised USD8 million last week, with Diamond Biofund accounting for half of this investment. More... (in Chinese)
NHI to cover CAR T-cell therapy for two types of cancer from November
16 October, 2023
From November, patients with two types of cancers will be eligible to receive CAR T-cell treatment under Taiwan's National Health Insurance (NHI) system, the National Health Insurance Administration (NHIA) said Sunday.

The treatment, which takes immune T cells and modifies them with chimeric antigen receptors, or CARs, so that they can recognize and destroy cancer cells, will be available to patients with acute lymphoblastic leukemia (ALL) or relapsed or refractory diffuse large B cell lymphoma (DLBCL) that meet certain criteria, the NHIA said. More...
Made-in-Taiwan CGM expects to hit the market
16 October, 2023
Bionime Corporation announced that its continuous glucose meter (CGM) has been approved by Taiwan's Ministry of Health and Welfare for marketing, it will then compete with Abbott, Dexcom, Medtronic and other major international companies in the CGM market. More...
Taiwan Bio Industry Organization (Taiwan BIO)
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