09/22 Taiwan BIO Weekly
2025-09-22 |
| Taiwan BIO Weekly |
| PharmaEssentia files for drug approval in Japan with new indication for Ropeg 18 September, 2025 New drug company PharmaEssentia (TW: 6446) announced that it has submitted an application in Japan to expand the indication of its novel drug Ropeginterferon alfa-2b (Ropeg) to include essential thrombocythemia (ET). According to the review process of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the review is expected to take about one year, with approval anticipated in the third quarter of 2026, potentially benefiting around 30,000 ET patients in Japan. PharmaEssentia continues to advance global filings for Ropeg's ET indication. This year, the company has already submitted ET drug approval applications in China, Taiwan, and Japan. More... (in Chinese) |
| PwC Taiwan and ITRI release AI healthcare trends report 18 September, 2025 Artificial intelligence (AI) is rapidly reshaping the global healthcare industry, driving profound transformation from clinical decision-making to patient care. To capture this critical wave, PwC Taiwan, together with the Industrial Technology Research Institute (ITRI) and Mosaic Venture Lab, co-hosted a forum on biomedical innovation and the potential of smart healthcare. At the event, they jointly released a report on Taiwan's AI and smart healthcare environment, providing an in-depth analysis of global smart healthcare trends, while offering insights into Taiwan's strengths and challenges, outlining a roadmap for future action steps. More... (in Chinese) |
| Taiwan's Medical Tech Ignites Medical Fair Thailand 2025 17 September, 2025 Taiwan Excellence is celebrating a highly successful showing at Medical Fair Thailand 2025, where its pavilion was a major highlight of the three-day event. The exhibition, held from 10-12 September, brought together thousands of medical professionals and industry leaders at the Bangkok International Trade & Exhibition Centre (BITEC). More... |
| TWi Biotechnology's new treatment for postpartum depression completes Phase II enrollment, data expected Q4 17 September, 2025 Emerging-stock listed TWi Biotechnology (TW: 6610) announced that its oral new drug NORA520, developed for the treatment of postpartum depression (PPD), has completed patient enrollment in its US Phase II clinical trial. A total of 93 patients were enrolled, and a full efficacy analysis will be conducted after treatment completion. Key topline results are expected to be released in the fourth quarter of this year. More... (in Chinese) |
| Taiwan's Synmosa Biopharma eyes up to 30% stake in Genovate Biotechnology 17 September, 2025 Taiwanese pharmaceutical company Synmosa Biopharma (TW: 4114) on Monday announced plans to expand its operations through a public tender offer for a stake in Genovate Biotechnology. Synmosa plans to acquire 15% to 30% of Genovate at NT$24 (US$0.80) per share, valuing the maximum stake at around NT$827 million. This represents roughly a 30% premium over Genovate’s Monday closing price of NT$18.45, according to UDN Money and UsTV. More... |
| Senhwa Biosciences' CX-5461 Teams Up with Global PD-1 Leaders to Enter the Immunotherapy Arena, Targeting Multi-Billion Dollar Global Market Press release 16 September, 2025 Senhwa Biosciences, Inc. (TW: 6492) today announced its official entry into the fast-growing global immuno-oncology market. The Company's novel investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the approved PD-1 inhibitor Cemiplimab (Libtayo), provided by Sanofi and Regeneron Pharmaceuticals, in a Phase I/II clinical trial for patients with microsatellite-stable colorectal cancer (MSS CRC) who are refractory to immune checkpoint inhibitors. More... |
| Enimmune's new vaccine makes major strides in Thailand 16 September, 2025 Adimmune's (TW: 4142) subsidiary Enimmune (TW: 6564) announced that its EnVAX-A71 enterovirus 71 vaccine, produced by Adimmune, has successfully obtained GMP certification in Thailand, marking a significant step forward in the country's regulatory approval process. Since Adimmune's quadrivalent influenza vaccine has already secured both GMP and regulatory approval in Thailand, the approval of the enterovirus vaccine GMP further strengthens its position. Enimmune noted that Thailand, with relatively strong economic capacity in Southeast Asia and high vaccine acceptance, represents a market of approximately 3 million young children. More... (in Chinese) |
| Gongwin Biopharm-KY teams up with UAE pharmaceutical company to enter African market 16 September, 2025 Gongwin Biopharm-KY (TW: 6617), a new drug development company, announced on behalf of its subsidiary that it has signed a licensing and distribution agreement with an undisclosed pharmaceutical company headquartered in the United Arab Emirates (UAE). The partnership will advance Gongwin's lung cancer drug PTS302 (Tosylate Urea Injection) into Algeria in Africa. This marks another milestone in Gongwin's global licensing expansion, following agreements signed in July this year for the Malaysia and Taiwan markets. More... (in Chinese) |
| Taiwan aims to create biotech standard 15 September, 2025 Taiwan is leveraging its semiconductor, artificial intelligence (AI) and supply chain strengths to develop a national organ-on-a-chip (OOC) model, aiming to gain a competitive edge in biomedicine. The miniature devices simulate specific human cells and tissues under real physiological conditions. Taiwan's efforts to develop its own OOC model are led by the National Institutes of Applied Research. More... |
| Taiwan Asia Semiconductor enters the blood glucose monitoring market 15 September, 2025 Taiwan Asia Semiconductor (TW: 2340) is set to enter the medical-grade blood glucose monitoring market as its second-generation HUSD sensing chip, capable of precise alerts for high and low blood sugar, begins mass production in March next year. The chip will be integrated as a standard component in next-generation smartwatches and wireless earbuds from a major US consumer brand, which currently holds around 22% and 23.3% global market share in these categories. While existing regulatory limits restrict device functions to basic health alerts without displaying numerical values, approval will allow these health management features to become medical applications, showing actual blood pressure, heart rate, and glucose readings. More... (in Chinese) |
| Pharmosa Biopharm and Liquidia announce inhaled therapeutic L606 updates at Wells Fargo Healthcare meet 15 September, 2025 Pharmosa Biopharm (TW: 6875) announced that its licensing partner, Liquidia (LQDA), was recently invited to attend the 20th Annual Wells Fargo Healthcare Conference 2025, where it provided a detailed overview of the latest clinical progress, global competitive advantages, and market positioning of Pharmosa Biopharm's next-generation inhaled therapeutic, L606. Pharmosa Biopharm stated that within LQDA's product pipeline, Yutrepia (an inhaled short-acting dry powder drug) was launched earlier this year, and the company is now actively planning the development and launch of its second product, L606. LQDA noted that it has confirmed with major global regulatory agencies the clinical requirements for filing L606 in the US and Europe. More... (in Chinese) |
| FaceHeart's contactless heart and respiration tracking facial physiological monitoring system has obtained US FDA SaMD approval 22 July, 2025 Founded in 2018, FaceHeart leverages regular smartphone cameras and AI algorithms to use the human face as a signal source for measuring heart rate, respiration, blood pressure, and blood oxygen. It provides a contactless, continuous, and seamless health monitoring solution for the elderly, chronic disease patients, and long-term care, creating new applications in telemedicine and preventive care. FaceHeart's technology framework is built on the team's strong expertise in electronic engineering and image processing. Many of its core members come from National Yang Ming Chiao Tung University, specializing in the development and application of digital signal processing (DSP) and light source calibration algorithms. More... (in Chinese) |
| CH Biotech R&D's Precision-Oriented Peptides (POPs) green technology transforms agricultural waste into tool for stress resistance 22 July, 2025 CH Biotech R&D (TW: 6534), focused on developing agricultural new drugs, has long been dedicated to using scientific and systematic design to maximize the value of agricultural waste. Its innovative Precision Oriented Peptides (POPs) technology employs a high-efficiency, low-carbon process to transform agricultural residues such as chicken feathers and fish scales into peptides through subcritical green hydrolysis. More... (in Chinese) |
| Grape King functional probiotics for sports 'Kang Er Dong Pro & Prebiotics' wins international recognition and awards 22 July, 2025 In March 2024, Grape King Bio (TW: 1707) launched Kang Er Dong Pro & Prebiotics specifically targeting sports. The product combines 7-8 types of sports functional probiotics with sanghuang mycelium. Animal studies have confirmed its ability to enhance muscle strength, boost stamina, and improve training performance, helping athletes break through performance plateaus. The company stated that clinical trials are currently underway focusing on applications for joint protection and muscle strength enhancement in athletes. More... (in Chinese) |
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