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12/11 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
Lotus Pharmaceutical Announces First Shipment of Lenalidomide to Japan
Press release
7 December, 2023
Lotus Pharmaceutical (TW: 1795), a leading global pharmaceutical company, announces the delivery of its first shipment of Lenalidomide Capsules (generic version of Revlimid®) in 2.5mg and 5mg strengths to the Japanese market. This marks a significant milestone in Lotus' strategic expansion aimed at making medicine more accessible worldwide. More...
Taiwan Bio and TRACT Therapeutics, Inc. Announce Strategic Partnership to Advance a Novel Therapeutic Approach for Preventing Rejection in Solid Organ Transplant
Press release
6 December, 2023
Taiwan Bio and TRACT Therapeutics are pleased to announce a new strategic partnership to advance a cellular therapy to revolutionize the prevention of allograft rejection in solid organ transplant. The partners will launch a multi-center Phase 2 clinical trial investigating the reduction of immunosuppressant drugs in living donor kidney transplant recipients in both the United States and Taiwan. More...
Hukui Biotechnology's Smart Medical Devices Make Inroads into the United States
6 December, 2023
The electronic medical device contract manufacturer, Hukui Biotechnology, is venturing into the smart medical device market. The company was recently invited by the global semiconductor leader, Infineon Technologies, to participate in the 'OktoberTech 2023 North America' event in Silicon Valley, USA. During the event, the company showcased a prototype of a health smart ring developed in collaboration with Infineon, aiming to explore business opportunities in the US smart health monitoring wearable market.

Hukui Biotechnology stated that the showcased health smart ring can visually represent invisible body signals. Tailored to user habits, the application of the ring addresses challenges associated with long-term wear of other devices where data collection may be challenging. With the integration of algorithms and a dedicated app, the smart ring can serve as a personal health assistant, providing wearers with real-time insights into their physiological values. More...
Saving Lives Through Communication, Heroic Faith Medical Science Showcasing Novel AI Auscultation Tool for Procedural Sedation Patients in PGA 77
5 December, 2023
Founded in 2018, Taiwan-based Heroic Faith Medical Science is dedicated to developing AI-assisted breathing sound monitors. The company’s proprietary Airmod system, an active noise-canceling electronic stethoscope that seamlessly integrates with AI, enables continuous monitoring of patients’ breathing sounds. In December, Heroic Faith’s team will participate in the 77th PostGraduate Assembly in Anesthesiology (PGA77) in New York. They plan to host a Research Symposium and product launch program with the goal of expanding into the U.S. market, as well as seeking investors and partners for further applications of their product. More...
Research on the detection of antibodies and antigens using a novel SERS chip from National Chung Hsing University published in Applied Physics Reviews
5 December, 2023
New concept of epidemic prevention: antibodies detection instead of detecting viruses! Taiwanese scientists and General Manager at Protrustech Co., Ltd. Huang Chun-Ta, Distinguished Professor Chang, Chien-Chung from Graduate Institute of Biomedical Engineering of National Chung Hsing University, and Distinguished Professor Wang Guozhen of the Mechanical Engineering department led a team to develop a signal enhancement chip with a three-dimensional plasma hotspot (3D-PHS), which can successfully detect COVID-19 viruses, antibodies and antigens.

However, it was successfully published under the title "A multiscale 3D hotspot-rich nanostructured substrate for biomolecular detection of SARS-CoV-2" of Applied Physics Reviews in the world's top journal ranked No. 1 in the field of physics, was also selected as a featured paper. More...
Medigen Vaccine Biologics Applies for Market Approval of Enterovirus Vaccine in Malaysia
3 December, 2023
Medigen Vaccine Biologics announced the submission of its Enterovirus 71 vaccine for rReview to Malaysia's National Pharmaceutical Regulatory Agency (NPRA), targeting the market of 430,000 newborns in Malaysia.

Medigen noted that enterovirus infections are prevalent in the Southeast Asian region, with EV71 being one of the main pathogens. It possesses high neurotropism and pathogenicity, leading to severe complications such as limb paralysis, encephalitis, meningitis, pulmonary edema, hemorrhage, and even death. More... (in Chinese)
Synmosa Biopharma Products Granted Pharmaceutical Certification in China
3 December, 2023
Synmosa Biopharma (TW: 4114) announced that its Acetaminophen 600mg Effervescent Tablet obtained Chinese pharmaceutical certification and completed import inspection registration. With China facing a recent surge in the pneumonia epidemic, Synmosa is expected to see a significant increase in shipments in the near future. In the past five days, the stock price surged by 9.26 percent, closing at NT$41.3 on the 1st, reflecting a 2.73 percent increase. More... (in Chinese)
Academia Sinica Decodes DNA Repair Process, Results Published in 'Science'
2 December, 2023
Various types of DNA damage are often among the causative factors leading to cancer or genetic diseases. However, the repair process in living organisms remains a mystery. To unravel this genetic research puzzle, Academia Sinica researcher Tsai Ming-Daw led an international research team, utilizing the X-ray Free Electron Laser for the first time to capture the entire process of photolyase enzyme repairing DNA damage at atomic resolution. The research findings have been published in the renowned international scientific journal 'Science.' More... (in Chinese)
Beyond Medtech: Healthcare+ Expo Taiwan Sets New Stage for Global Innovation in Future AI Healthcare
1 December, 2023
The Healthcare + Expo Taiwan, currently taking place at Nangang Exhibition Hall 1 from November 30 to December 3, 2023, is poised to redefine the landscape of AI healthcare on a global scale. This year's edition boasts the remarkable participation of 650 companies, occupying 2,300 booths, and has garnered the attention of leading technology firms and hospitals across the Asia-Pacific region. More...
Taiwanese-Origin API Recognized by the EU, Listed in Third-Country List – Export to Europe Exempt from Attaching Written Certification
30 November, 2023
The European Union mandates that non-EU-produced active pharmaceutical ingredients (API) must be accompanied by written certification upon import to ensure their production complies with EU Good Manufacturing Practice (GMP) standards, preventing counterfeit drugs. However, countries listed as third countries by the EU are exempt from this requirement. The Taiwan Food and Drug Administration (TFDA) announced yesterday that Taiwan has gained EU recognition and successfully joined the list of third countries, demonstrating the high quality of domestically produced APIs on a global scale.

Currently, a total of nine countries have successfully entered the EU's third-country list, including Taiwan, Canada, South Korea, Australia, Brazil, Israel, Japan, Switzerland, and the United States. More... (in Chinese)
MetaTech Collaborates with Acer to Utilize AI Technology in Combating Colorectal Cancer through Dendritic Cells
30 November, 2023
MetaTech (TW: 3224) held a press conference at the recently concluded Healthcare+ Expo Taiwan, announcing its collaboration with Acer Group (TW: 2353). The company plans to leverage Acer's artificial intelligence (AI) technology to develop dendritic cells with therapeutic potential to combat colorectal cancer, aiming to apply for Investigational New Drug (IND) status in the first quarter of the coming year. MetaTech stated that through the digital manufacturing blueprint provided by AI, they will become a "technology company engaged in regenerative medicine." More... (in Chinese)
Inventec Expands into Smart Healthcare, Collaborates with Taipei Veterans General Hospital to Develop Wound Assessment Software
28 November, 2023
Inventec (TW: 2356) has achieved success in the field of smart healthcare. The company announced that its AI Research Center, in collaboration with Taipei Veterans General Hospital, has developed the "Inventec Love Skin" smart wound software. Following the acquisition of the Ministry of Health and Welfare's Medical Device Manufacturing License last year, it has recently obtained Taiwan's class II medical device certification. This is the first case in the country where a pure software design, operated in an app mode, has obtained class II smart medical device certification. It is optimistic that after commercialization, the revenue of the smart healthcare business will see significant growth. More... (in Chinese)
Compal Electronics' Handheld Ultrasound to be Launched in North America Next Year
27 November, 2023
Compal (TW: 2324) has achieved new progress in its biomedical business. Its subsidiary, Aco Healthcare, unveiled its second-generation Apache neo series handheld ultrasound at this year's Radiological Society of North America (RSNA) Annual Meeting. Compal Vice Chairman and Aco Healthcare Chairman Chen Rui-Cong stated that this product series has obtained US FDA certification and will be launched in North America in 2024. More... (in Chinese)
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