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2/6 Taiwan Life Sciences Biweekly Newsletter


Taiwan Life Sciences Biweekly
1. Inside Taiwan's 'AI hospital of the future'
3 February, 2023
The telltale signs of infection appeared soon after the patient arrived in the emergency room. So doctors at China Medical University Hospital (CMUH) ordered a lab test to identify the culprit.

Three days later, they got their answer: a drug-resistant bacteria. This particular bug had evolved to outfox most antibiotics, even ones used as a last resort. It is a notorious and potentially fatal threat that haunts hospitals worldwide.

But by then the patient was about to be discharged. That's because an AI model developed by CMUH had already identified the bacteria ?in one hour, compared with the 72 hours the standard lab test took. Doctors had prescribed new drugs as a result, and the patient recovered. More...
2. Chang Gung Hospital signs MOU with Pfizer to facilitate research and clinical trials
1 February, 2023
Chang Gung Memorial Hospital, Linkou announced that it has signed a memorandum of understanding with Pfizer in Taiwan to collaborate on solving more clinical problems and has set up a three-stage plan to promote medical education and academic seminars in the first stage, develop medical research projects in the second stage, and promote the internationalization of clinical trials in Taiwan in the third stage to strive for more medical resources to connect with the international community. More...
3. AmCad Biomed, PhytoHealth make headways in medical device and drug approval
1 February, 2023
PhytoHealth Corp., a subsidiary of the Maywufa Healthcare Group's, is expected to launch its second new drug Oraphine capsule in Taiwan this year whilst sourcing overseas sales partners. AmCad Biomed's product AmCAD-UO for obstructive sleep apnea is anticipated too, to obtain its clearance in Korea this year. AmCad is also working on establishing its demonstration site at the Stanford Sleep Medicine Center. More...
4. Formosa Pharma plans to file for US approval of eye treatment
1 February, 2023
Taiwan biotech Formosa Pharmaceuticals plans to file a new drug application (NDA) in the USA for its eye treatment asset APP13007, which, according to the company, is the first eye drug using clobetasol, a steroid usually for skin conditions. More...
5. Draft Amendments to the Rules of Medical Diagnosis and Treatment by Telecommunications Pre-announced by the MOHW of Taiwan
31 January, 2023
The Rules of Medical Diagnosis and Treatment by Telecommunications (hereinafter, the "Rules") were enacted and implemented on May 11, 2018 as a sub-law authorized under the proviso of the Physicians Act on the "principle of in-person diagnosis," which, for the first time, breaks the restrictions on the conditions of diagnosis and treatment by telecommunications in "mountainous areas, outlying islands, and remote areas" and in "emergencies" and stipulates that diagnosis and treatment by telecommunications can apply to patients who have special care needs under "special circumstances". More...
6. Formosa Pharmaceuticals Announce A Summary Of Integrated Clinical Results For APP13007 For The Treatment Of Inflammation And Pain After Cataract Surgery
31 January, 2023
Press release
Formosa Pharmaceuticals, Inc. (TW: 6838) report a summary of integrated clinical results for APP13007, a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain after cataract surgery. More...
7. Caliway's CBL-514 to lose subcutaneous fat greenlighted by FDA for phase 2b trial
31January, 2023
Caliway Biopharmaceuticals announced that its new drug CBL-514 for subcutaneous fat reduction (non-surgical local fat reduction) has been approved by FDA for phase 2b clinical trial. Its shares rose by 15% as per Taipei Exchange (ESB stocks), reaching the highest price of NT$195.5 since its stock traded. More...
8. TWi Pharmaceuticals launches Dexlansoprazole DR Capsule in the US market
31 January, 2023
Bora Pharmaceuticals (TW: 6472) announced that its subsidiary, generic drug firm TWi Pharmaceuticals, had successfully launched Dexlansoprazole DR Capsule (a generic drug of Dexilant) in the US market, the first generic drug manufacturer to sell this generic drug form in the US. More... (in Chinese)
9. Oneness Biotech's new drug for diabetic foot ulcers passes Singapore review
31 January, 2023
Onceness Biotech announced that Fespixon, its new drug for diabetic foot ulcers, had obtained Singapore drug certificate review. This drug was independently developed by the company in Taiwan. Singapore is only the second country to certify this drug after Taiwan, with licensing at the approval stage in mainland China, several Southeast Asian markets, and the US. More... (in Chinese)
10. MiiS approved for its disposable endoscope
30 January, 2023
Medimaging Integrated Solution Inc. (MiiS)'s self-developed and manufactured disposable endoscopes have obtained the Taiwan Ministry of Health and Welfare's TFDA Class II medical device license and the US FDA 510(k). More...
11. Taiwan's smart medical care enters the Middle East
29 January, 2023
As the COVID pandemic eases, exchanges in tourism, academics, and medical care are becoming more and more prevalent. Taiwan is taking this opportunity to promote its smart medicine strengths and capabilities around the world. An example of this, Taiwan smart medical firm Formosa Wealth Biocell Technology recently signed a memorandum of cooperation in Manama, Bahrain, looking to introduce Taiwan's medical services and smart medical technology to this nation through the Taiwan Tourism Medical Development Association, and become a member of the GCAP (Global Covid Association Partners). GCAP is a global organization dedicated to the development of a platform for humanitarian organizations on smart healthcare and sustainable issues, headquartered in the United States. More... (in Chinese)
12. PharmaEssentia expects to obtain Japanese drug certificate for Ropeg in the first half of 2023
29 January, 2023
PharmaEssentia (TW: 6446) announced that it had received a successful GMP inspection from Japan's drug regulation body the Pharmaceuticals and Medical Devices Agency (PMDA) of its Taichung API and injection filling factory, and is thus expected to obtain the Japanese drug certificate in the first half of 2023 for its drug Ropeginterferon alfa-2b (Ropeg, or P1101) for the treatment of Polycythemia Vera (PV). More... (in Chinese)
13. The Road to a Sustainable Precision Health Ecosystem in Taiwan
20 January, 2023
Numerous databases used in healthcare are based on data from Caucasian patients and research participants, but predictions derived from these data aren掐 always as accurate when applied to patients from other ethnicities. The Taiwan Precision Medicine Initiative aims to use Han Chinese-specific data to optimize patient care in Taiwan. The global Han Chinese population is around 1.4 billion people, with 95% of the Taiwanese population having Han Chinese ancestry.

Technology Networks spoke to Dr. Pui-Yan Kwok, the leader of the Taiwan Precision Medicine Initiative, about what the initiative is doing to implement a sustainable precision health ecosystem in Taiwan, the challenges facing precision medicine and what the initiative hopes to achieve in the future. More...
14. Cell Therapy Centre at Shuang Ho Hospital provides patients cancer treatment options
19 January, 2023
The Cell Therapy Centre, opened on 18 January and operated by Taipei Medical University- Shuang Ho Hospital, providing patients with an important alternative to conventional medical treatment. Cell therapy can be applied to combat cancer cells, as well as immune cell therapy, including joint repair, such as degenerative arthritis or cartilage cell regeneration; epidermal or subcutaneous tissue repair, such as skin burns; eye treatment, such as retinal regeneration; and neurological regeneration, such as Alzheimer's and Parkinson's. More...
15. China Medical University Hospital among top smart hospitals by US digital health certification body
18 January, 2023
China Medical University Hospital, based in Taichung, was named one of the world's top three smart hospitals by the HIMSS, a certification body for digital health transformation. Inpatients are given a tablet to check on their physiological data and drug information. They can carry this information with them after leaving the ward, with the hospital's smartphone app. Another function of the app is that it allows patients to reach out to their doctors remotely. More...
16. NTU Hospital-developed AI model spots gastric abnormalities in just 9 seconds
18 January, 2023
Stomach cancer is one of the top 10 cancers in Taiwan, and H. pylori infection is an important risk factor. Once infected, it changes the "stomach phase" and it can take up to a month to determine whether there are any abnormalities in the mucous membrane of the stomach from the time of gastroscopy to the time of returning to the clinic for a biopsy. According to the latest release of medical AI developed by the NTU Hospital, based on the gastroscopic images from the 10 branches of the NTU system over the past decade, the artificial intelligence model can accurately determine the gastric phase in just 9 seconds, with an accuracy rate of over 90%. More...
17. Lotus Obtains Tentative Approval for Nintedanib ANDA from the US FDA
16 January, 2023
Press release
Lotus Pharmaceutical ("Lotus" or "the Company," Taiwan TWSE ticker: 1795), a multinational pharmaceutical company, announced today that the US Food and Drug Administration (US FDA) has granted a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, the generic version of Boehringer Ingelheim's OFEV. Lotus expects to launch the generic Nintedanib Capsules at the earliest available opportunity. More...
18. ITRI and China Medical University Hospital signed MOU for robotic solutions
16 January, 2023
ITRI announced the signing of a Memorandum of Understanding with the China Medical University Hospital (CMUH). At the same time, ITRI is expected to join hands with the medical device manufacturer, Remex Medical Corp., the subsidiary of INTAI Technology Corp., and Techman Robot, the subsidiary of Quanta Storage Inc. to integrate the two advantageous industries in Taiwan, namely medical and information and communication, with cross-field technology and introduce hospital robots into CMUH. ITRI Executive Vice President Pei-Zen Chang said that the collaboration focuses on the robot to provide intelligent surgery, transportation management and infection control and cleaning related solutions, working towards the goal of hospital automation and intelligence. More...
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