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8/29 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
1. Robots among TMUH's cerebral palsy treatments
28 August, 2022
Taipei Medical University Hospital (TMUH) yesterday showcased new treatments for cerebral palsy, including using robots to assist children with limb rehabilitation, which it says helps improve walking speed and grip strength. More...
2. StemCyte, a subsidiary of Microbio, announces planned Phase II trial of RegeneCyte for Long Covid
25 August, 2022
StemCyte, a subsidiary of Microbio Group (TW: 4128), announced on the 25 August that its umbilical cord blood cell drug RegeneCyte has been approved by the US FDA for a Phase II clinical trial for the treatment of so-called ' Long Covid', being the world's first clinical trial for the treatment of long term effects of Covid-19 infection using umbilical cord blood cells.

StemCyte develops umbilical cord blood preservation and cell therapy products. Its RegeneCyte cord blood cell therapy is currently used to treat hematopoietic system diseases, immune system diseases and inborn metabolic diseases.

There are three main symptoms of Long Covid, including fatigue, brain fog and muscle pain, and may also be accompanied by shortness of breath, chills, body aches, headache, joint pain, chest pain, cough, persistent loss of taste or smell and other symptoms, which can last for several weeks, months or even more than a year. More... (in Chinese)
3. Lotus Pharmaceutical's generic cancer drug has been tentatively approved by the US FDA
25 August, 2022
Taiwan-based Lotus Pharmaceutical announced this week that its application for a generic drug license for its cancer drug Midostaurin Soft Capsules, a generic drug of Novartis Rydapt? has been given tentative approval by the US FDA. Rydapt is used in combination with certain chemotherapy medicines to treat adults with newly diagnosed acute myeloid leukemia (AML) who have a defect in a gene called FLT3.

"This is Lotus Pharmaceutical's third cancer drug project for the US market, following Metrotrexate and Lenalidomide," mentioned Petar Vazharov, General Manager of Lotus Pharmaceutical.

According to IQVIA statistics, Rydapt sales in the US in 2021 were around US$83 million. No other competitor to Rydapt is currently licensed in that country. More... (in Chinese)
4. Taiwan researchers develop spider silk-based fiber optic sugar sensor
23 August, 2022
Scientists at Taiwan's National Yang Ming Chiao Tung University (NYCU) have developed a fiber optic sugar sensor using silk from golden orb weaver spiders, a technology they say could eventually be used to create next generation glucose meters for diabetics.

The research, which was led by Professor Liu Cheng-yang and master's graduate E Hsuan-pei of the university's Department of Biomedical Engineering, is published in the September edition of the scientific journal Biomedical Optics Express. More...
5. Phase III clinical trial of Foresee Pharmaceuticals' new drug for central precocious puberty begins
23 August, 2022
Foresee Pharmaceuticals (TW: 6576) announced on 22 August that its new drug FP-001 42mg, a new dosage form for the treatment of children with central precocious puberty, will start a Phase III clinical trial in the US, Europe, mainland China and Taiwan. It is expected to recruit 93 patients and be completed within three years.

Childhood central precocious puberty is a disease of early sexual development in girls and boys due to the premature activation of the hypothalamus, pituitary gland, and gonadal axis. More... (in Chinese)
6. TaiDoc Technology cooperates with Japanese manufacturer NIPRO for COVID-19 antigen rapid screening kit
22 August, 2022
TaiDoc Technology (TW: 4736) announced this week that its COVID-19 antigen rapid screening kit developed in cooperation with the Japanese medical materials manufacturer NIPRO has been certified by Japan's PMDA (Pharmaceuticals and Medical Devices Administration), and may officially enter the Japanese market.

NIPRO assisted TaiDoc Technology to conduct clinical trials in Japan and then applied to Japan's Ministry of Health and Welfare to obtain medical material evidence in accordance with the PMDA model. The two parties intend to continue to deepen their business cooperation in Japan and the global market, according to the press release. More... (in Chinese)
7. Taiwan, Indiana sign cooperation agreement on chips, biotech and energy
22 August, 2022
Taiwan and the state of Indiana will work together on energy, biotechnology and semiconductor manufacturing. That掇 under the terms of a new memorandum of understanding. More...
8. Oneness Biotech's Bonvadis topical cream for wounds has received US FDA marketing approval
20 August, 2022
Oneness Biotech (TW: 4743), a subsidiary of the Microbio Group, announced last week that it has received a notification from the US FDA that its Bonvadis topical cream for wounds had received the US FDA 510(k) substantial equivalence determination and marketing authorization. In other words, the product will be available for sale in the US, with an opportunity to capture the large wound care market opportunity in that country. More... (in Chinese)
9. National Yang Ming Chiao Tung University joins hands with alumni to develop new Alzheimer's disease drugs
18 August, 2022
National Yang Ming Chiao Tung University and a select group of alumni have jointly developed oral immunomodulatory drugs for Ahzheimer's Disease through industry-academia cooperation, according to an announcement today. Alzheimer's disease is often accompanied by excessive activation of immune cells in the brain. Phase I clinical trials have been completed, with the group set to receive the only funding from the United States Alzheimer's Association this year for a future Phase II trial.

National Yang Ming Chiao Tung University researchers explained their new drug was based on the observation that when microglia in the brain, a type of immune cells in the central nervous system, detect pathogens or harmful substances, they initiate an immune inflammatory response to prevent life-threatening damage. However, recent studies have found that some abnormal microglia cells over-activate the immune inflammatory response, which is one of the important causes of nerve damage and degeneration, further aggravating Alzheimer's disease. Such discoveries opened the door for immunotherapy to treat Alzheimer's disease. More... (in Chinese)
10. Taiwan Excellence Pavilion to showcase 10 leading medical tech innovators at Medical Fair Asia 2022
17 August, 2022
Taiwan Excellence will be participating for the first time at the Medical Fair Asia 2022, to be held on-site at Marina Bay Sands from 31 August to 2 September, and online from 3 to 9 September.

Organized by Taiwan's Bureau of Foreign Trade and Taiwan External Trade Development Council (TAITRA), the Taiwan Excellence Pavilion will be showcasing 10 exhibitors and a range of products such as surgical devices, medical and dental navigation solutions, Point-Of-Care Technology and decentralized medicine and mobility scooters over the three-day show. More... (in Chinese)
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