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9/11 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
Taiwan launches its first homegrown drug for breast cancer
8 September, 2023
GNTbm held a press conference yesterday to launch the new oral anti-breast cancer drug Kepida, providing an innovative treatment option for HR+/HER-2- advanced breast cancer patients in Taiwan. Kepida is a next-generation histone deacetylase inhibitor (HDACi), Tucidinostat, primarily designed to sensitize endocrine therapy (combined with Exemestane) through its unique epigenetic regulation mechanism. It is intended for the treatment of HR+/HER-2- advanced breast cancer patients who have previously failed or experienced relapse following endocrine therapy. More...
TaiMed's HIV treatment shows significant progress, accelerating its launch
7 September, 2023
TaiMed Biologics (TW: 4147) officially announced the successful completion of the clinical trial for the combination therapy of TMB-365 and TMB-380 long-acting drugs for the treatment of HIV-1b/2a in the pioneer group. After professional dosage selection, the required dosages for the two-month combination therapy have been confirmed, achieving the predetermined goals for this pioneer group clinical trial. More...
Sunny Pharmtech and TCM Biotech join forces to compete in the global pharmaceutical market
5 September, 2023
Last week Sunny Pharmtech (TW: 6676) announced the signing of a Letter of Intent for cooperation with TCM Biotech (TW: 4169). Both parties will collaborate on the development, production, and sales of active pharmaceutical ingredients (APIs) and formulations, with the aim of introducing Taiwanese-manufactured drugs to the international market.

In particular, Sunny Pharmtech will assist TCM Biotech in developing and manufacturing the API for the new drug U101, which will be used in TCM Biotech's phase III clinical trials for the prevention of recurrent urinary tract infections (rUTI). More... (in Chinese)
COVID-19 / Influenza Two-in-One Antigen Test Kit: Taiwan's Formosa Biomedical enters the Japanese market
4 September, 2023
Formosa Biomedical announced that its groundbreaking COVID-19/Influenza Two-in-One Antigen Test Kit received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in early August. It obtained the pharmaceutical license for in-vitro diagnostic use in Japan, with an initial order of 250,000 test kits. With the ongoing recovery of the tourism industry in Japan, the demand is expected to grow further. More... (in Chinese)
BIO Asia-Taiwan 2023: Embracing Asian Dynamics around precision health and CDMO
31 August, 2023
The Taiwan Bio Industry Organization (Taiwan BIO) and the global Biotechnology Innovation Organization (BIO) ignited Taiwan's three-day conference BIO Asia-Taiwan 2023 from July 26 to 30 at the Taipei Nangang International Exhibition Center (TaiNEX 1 and TaiNEX 2). The Onsite + Online International Conference and Exhibition was launched with the theme "Embracing Asian Dynamics" to comprehensively address the opportunities and challenges in Asia's biomedical and healthcare sectors. Enthralling conferences, exhibitions, and collaboration forums substantiated innovations, exemplified trends and business partnership opportunities. More...
Call for developing Taiwan's own venture for biomedical big data
31 August, 2023
The three-day BTC conference concluded today. Dr. Pan-Chyr Yang, VP of IBMI and industry professionals offered to have provided 32 recommendations based on five directions.

The advice on creating a new venture for the use and application of biomedical big data was given by experts including Dr. Yang, Chairman Johnsee Lee of Quark Biosciences and Prof. Hong-Jen Chang at the Institute of Public Health, National Yang Ming Chiao Tung University. The delivery through a build-operate-transfer model is anticipated to upscale Taiwan's biomedical industry. More...
Minister touts the WHO's approval of Medigen vaccine
31 August, 2023
The WHO’s addition of Medigen Vaccine Biologics Corp's COVID-19 vaccine to its pool marks the first time the world body has authorized a Taiwan-made vaccine and it is an endorsement of the country's vaccine industry, Minister of Health and Welfare Hsueh Jui-yuan said yesterday. More...
NHIA to dedicate office to adding drugs to NHI faster
31 August, 2023
The National Health Insurance Administration (NHIA) plans to set up a specialized office to speed up the process of adding new drugs to National Health Insurance (NHI) coverage, administration Director-General Shih Chung-liang said yesterday. More...
NSC 2023 MEDICA Taiwan delegation formed
31 August, 2023
On August 31st, the National Science Council (NSC) held the 2023 MEDICA Bootcamp international training camp for companies preparing for exhibitions and international negotiations. Representatives from MEDICA, AstraZeneca, Ernst & Young, and the Chinese Development Corporation were invited to serve as industry mentors. These mentors will assist the teams in establishing exhibition strategies, enhancing presentation and negotiation skills, and participating in ventures to vie for global excellence. More... (in Chinese)
Medeon Biodesign's thoracic aorta repair medical device undergoing clinical trials in the US
30 August, 2023
Medeon Biodesign (TW: 6499) is celebrating a breakthrough in its medical device development. Its thoracic aorta repair medical device, Duett, has received approval for clinical trials from the US FDA. The trial is expected to enroll 20 patients initially, with the possibility of expanding the scale of clinical trials upon approval. The data collected from this trial, which will evaluate clinical outcomes over 30 days, will serve as the primary trial indicator for subsequent registration applications. More... (in Chinese)

29 August, 2023
Premier Chen Chien-jen yesterday said the government plans to build the local biotechnology industry into the next sector to generate NT$1 trillion (US$31.37 billion) in production value. More...

TAHO Pharmaceuticals develops thrombosis-fighting oral dissolving film
29 August, 2023
TAHO Pharmaceuticals' new drug development shows progress as its Phase III clinical trial for the anti-thrombotic oral dissolving film 505(b)(2) new drug has received approval from the US FDA to conduct a bioequivalence (BE) study comparing blood concentration with the original tablet formulation. Since this trial only requires recruiting dozens of healthy subjects and can be completed in approximately two months, it is expected that the company will have the opportunity to apply for drug approval by the end of next year and launch in 2025. More... (in Chinese)
BTC Opening: Experts Offer Seven Key Recommendations, Inviting Microsoft CEO to Discuss Generative AIA
28 August, 2023
The Executive Yuan's Biotechnology Industry Development Strategy Advisory Committee (Bio Taiwan Committee, BTC) meeting, which began today and lasts for three consecutive days, had BTC members expressing their views. They stated that after collecting recommendations from various experts, the organizing body, the Science and Technology Office of the National Science Council (NSC), has summarized seven key focus areas. Artificial Intelligence (AI), National Health Insurance (NHI) coverage, smart healthcare, and Contract Development and Manufacturing Organization (CDMO) have become the most closely watched points by various experts. More... (in Chinese)
Yingshuo Biotech Pharmaceuticals aims to launch new drugs in the China market
28 August, 2023
Yingshuo Biotech Pharmaceuticals (TW: 6677) is currently preparing for the launch of the psychiatric drug Mirtazapine Hydrochloride (capsules) in China in collaboration with its Chinese partner. It is expected to be one of the key drivers for the next wave of revenue growth. More... (in Chinese)
Digital health faces regulatory challenges: Pan-Chyr Yang, VP of IBMI
25 August, 2023
Dr. Pan-Chyr Yang, vice president of IBMI and academician of Academia Sinica, said on 23 August that artificial intelligence and precision medicine are the most important trends in the healthcare industry in the near future, and that Taiwan should develop precision health for every age. However, the adoption of digital technology in precision medicine and smart healthcare is facing the dilemma that described 'best game but no one played', and it is suggested that technology companies should not try to develop "total solutions" at once, but should solve healthcare problems one step at a time. More...
"Taiwan Medical and Healthcare Regional Partnership" came to fruition
28 August, 2023
After taking over the government's New Southbound programme, Chang Gung Memorial Hospital (CGMH), together with the Medical Excellence Taiwan (MET) and Taiwan's medtech companies, went to Malaysia to explore a new blue ocean for Taiwan's healthcare. CGMH and local organizations jointly organized a large-scale symposium on 26 August, focusing on the "smart hospital" and sharing of the results, including representatives from the Universiti Malaya, HMI Group, Gleneagles Hospital and Tung Shin Hospital, and companies from Taiwan. More than 300 attendees participated online and in-person. They explored how to assist more healthcare partners in Malaysia to build smart hospitals and improve patient satisfaction through the innovation of medical devices, information systems, and other tools, or digital transformation. More...
Taiwan Bio Industry Organization (Taiwan BIO)
Contact: Daisy Tsai
Tel: +886 2 27836028 ext 14 FAX : +886 2 27836027
Mobile: +886 933-139647 | Line ID : daisy222

BIO Asia-Taiwan July 26-30, 2023

Taiwan Bio Industry Organization (TBIO)
Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd.,
Nangang Dist., Taipei, Taiwan (11571)