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4/24 Taiwan Life Sciences Biweekly Newsletter

2023-04-22

Taiwan Life Sciences Biweekly
Synbio Tech's plant-derived Lactobacillus TWK10R granted US patent
20 April, 2023
Biotech company Synbio Tech recently announced that its probiotic product Lactobacillus TWK10R has obtained a US patent for its functional applications in improving muscle weakness in the elderly and maintaining or increasing muscle mass and strength. The company reported that TWK10R can be considered one of the most important new probiotic raw materials developed in Taiwan in recent years.

Studies have found that supplementing TWK10R can effectively increase the muscle quality of animals and adults, which is beneficial for exercise performance. The probiotic has already obtained patents in multiple countries including Taiwan, and Japan, and has won awards in the US and Europe. More... (in Chinese)
 
CMUH recognized as Smart Hospital Initiative of the Year
19 April, 2023
China Medical University Hospital's (CMUH) digital transformation to a smart hospital has generated more great news: after entering the top three of global smart hospitals based on the Digital Health Indicator (DHI) conducted by the US HIMSS this year, CMUH won the "Smart Hospital Initiative of the Year" award in the Healthcare Asia Awards 2023 in Singapore, and was the only winning hospital from Taiwan, once again putting Taiwan on the international stage in the field of medicine. This achievement also shines a light on the New Southbound Policy which has been heavily promoted by the government. More...
 
Polaris Group to present clinical results for new cancer drug at AACR Annual Meeting in US
18 April, 2023

Polaris Group (TW: 6550) announced that it will present clinical trial data for its metabolism therapy new drug, ADI-PEG 20, at the Clinical Trials Plenary Session of the American Association for Cancer Research (AACR) Annual Meeting. Due to recent positive trial results showing strong potential for treating other cancers, the drug has received significant attention at the AACR Annual Meeting.

Polaris stated that ADI-PEG 20 is the world's first novel cancer treatment targeting the consumption of arginine. The data released to date is based on the treatment of malignant pleural mesothelioma patients, and is statistically significant. More... (in Chinese)
 
HanchorBio Announces US IND Clearance for the Multi-Regional Clinical Trial of HCB101 to Treat Solid and Hematological Malignancies
17 April, 2023
HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the US FDA has cleared its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. More...
 
Berkeley Public Health launches third round of Health Innovation Accelerator program
17 April, 2023
In late February 2023, UC Berkeley School of Public Health welcomed the third cohort of its Health Innovation Accelerator (formerly the Taiwan-Berkeley Health Innovation Accelerator). Five medical technology startups were selected to participate in the program as part of an ongoing partnership with the National Development Council in Taiwan.

The Health Innovation Accelerator will connect the teams with health systems leaders, executives at life sciences companies, experts in regulatory and reimbursement strategies, successful entrepreneurs, life science investors, and other resources to promote the teams?long-term success. More...
 
PharmaEssentia snagged US$462M, the largest overseas fundraising to Taiwan
14 April, 2023
In cooperation with MacKay Memorial Hospital, Compal Electronics, and Techman Robot, ITRI unveiled a remote-operated 5G ultrasound technology. This technology provides remote areas with access to essential medical resources, allowing rural residents to receive abdominal ultrasound checkups without having to travel long distances to urban areas. Efforts are underway to provide more accessible telemedicine services. More...
 
MegaPro Biomedical to present MPB-1734 preclinical data at AACR
13 April, 2023
MegaPro Biomedical (TW: 6827) reported that Vice President of R&D Dr. Xu Yuanhong will present the preclinical data of a new formulation of the anticancer drug MPB-1734 at the annual meeting of the American Association for Cancer Research (AACR). Date shows that MPB-1734 can effectively reduce the side effects of myelosuppression and show excellent anti-tumor effects against various animal tumor models. Giant Biomedical said that the development of MPB-1734 is based on the company's in-house developed nano-cell technology platform. More... (in Chinese)

AI Tool Predicts Colon Cancer Survival, Treatment Response
13 April, 2023
A new artificial intelligence model designed by researchers at Harvard Medical School and National Cheng Kung University in Taiwan could bring much-needed clarity to doctors delivering prognoses and deciding on treatments for patients with colorectal cancer, the second deadliest cancer worldwide. More...
 
MVC's EV71 vaccine approved in Taiwan
13 April, 2023
Medigen Vaccine Biologics Corp. ('MVC')'s EV71 vaccine obtained the approval from Taiwan's Food and Drug Administration (TFDA) on 12 April, which is the first enterovirus vaccine approved in Taiwan without the accelerated approval pathway. MVC pointed out that it will be marketed in Taiwan as soon as possible and will apply for approvals in Southeast Asia and other markets. More...
 
OBI Pharma and BiOptic to present at international conferences
12 April, 2023
Taiwan biotech companies will be presenting their latest achievements at international biotech conferences and exhibitions, including the American Association for Cancer Research (AACR), where OBI Pharma will present two therapeutic developments, and BiOptic, which will be making its first trip to Vietnam to promote its testing products. More...
 
Taiwan Shionogi seeks emergency approval for drug to treat Covid-19
12 April, 2023
Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorization (EUA) for ensitrelvir fumaric acid (ensitrelvir). More...
 
What is a "new drug"? Is the Ministry of Health and Welfare Entitled to Remove or Change Information on Orange Book ex officio? - Judges' Opinions Were Divided
11 April, 2023
What is a "new drug" and what is its scope? According to Article 7 of the Pharmaceutical Affairs Law, it means any drugs that have been reviewed and determined by the Taiwan FDA of MHW to be new chemical entities, new indication/combination, or preparations with new administration route. However, Article 39.2 of the Guidelines for Drug Review and Recordation for Patent Linkage System to which the Pharmaceutical Affairs Law applies mutatis mutandis also set out that new drugs include preparations with new dosage form, new administration dose, or new unit strength. More...
 
BioGend Therapeutics' Osteo-Inductive Factor (OIF) product authorized in Japan
9 April, 2023
Taiwanese high-end orthopedic medical device manufacturer, BioGend Therapeutics (6733), has announced that it has signed an exclusive licensing agreement with Fujimoto Pharmaceutical Corp., a Japanese drug manufacturer, for their bone regeneration product, Osteo-Inductive Factor (OIF), completing its first international market authorization. The contract signing fee will be recognized in the second quarter.

BioGend reported that this milestone agreement should increase the willingness of more companies to cooperate on licensing agreements. Currently, the company is actively engaged in business negotiations with partners in China, and it is expected to sign a cooperation contract by the end of this year. More... (in Chinese)
 
Taiwan strives to become Asia-Pacific biotechnology hub: Vice Premier
8 April, 2023
Taiwan is striving to become the biomedical hub of the Asia-Pacific region, said Vice Premier Cheng Wen-Tsan today during the MPN Asia 2023 international conference, hosted by PharmaEssentia and the Taiwan Society of Hematology. While acknowledging that there is still a long way to go, he highlighted that the value of related industries in Taiwan has already exceeded NT$600 billion, and that innovation and R&D are the driving forces of economic growth. He expressed the hope that biotech and medical industries would become a trillion-dollar industry and another national treasure, alongside Taiwan's famous Alishan mountain.

In his speech, Cheng Wen-Tsan noted that PharmaEssentia has witnessed the development of Taiwan's biotech industry over the past 20 years, including the formulation and revision of the Biotech and Pharmaceutical Industry Development Act, which last year included precision medicine, digital medicine, and regenerative medicine. The government is now promoting the Regenerative Medicine Dual Bill (Regenerative Medicine Act draft and Regenerative Medicine Preparations Act draft) for passage. More... (in Chinese)
 
Taiwan's first brainwave AI approved by the US FDA
8 April, 2023
HippoScreen Neurotech announced that its BDR Dementia Risk Assessment System has been approved by the US FDA, becoming the first brainwave technology product in Taiwan to obtain qualification for cognitive function assistance evaluation in the United States.

The BDR Dementia Risk Assessment System is an AI brainwave analysis technology that provides medical personnel with an objective, quantifiable, and fast tool for assessing the risk of brain function deterioration. The evaluation tool was developed through the collaboration between HippoScreen Neurotech and four local medical centers, collecting a large amount of brainwave data from patients with mild cognitive impairment (MCI) and dementia, and then training and validating AI models to provide quantitative physiological signals. More...
 
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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
Email: daisy@taiwanbio.org.tw

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