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5/9 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery
Press release
5 May, 2023
Formosa Pharmaceuticals, Inc. (TW: 6838) and AimMax Therapeutics, Inc. (United States) announce the submission of a New Drug Application to the United States Food and Drug Administration (US FDA) for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery. More...
PharmaEssentia Initiates Phase 3b Trial of Ropeginterferon alfa-2b-njft Investigatng New Dosing Regimen for Patients With Polycythemia Vera (PV)
Press release
3 May, 2023
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the first patients are now being dosed in ECLIPSE PV, a Phase 3b clinical study evaluating an accelerated dosing schedule for ropeginterferon alfa-2b-njft using a prefilled syringe for the treatment of adults with polycythemia vera (PV). More...
Taikang Biotech's breast cancer biosimilar drug completes Phase I trial
2 May, 2023

Taiwan's Taikang Biotechnology (TW: 6589) announced that its second HER2-positive breast cancer biosimilar drug, EG1206A, has completed a Phase 1 clinical trial (EGC101) in Europe. Trial data analysis has shown that EG1206A met bioequivalence standards of pharmacokinetics (PK) compared to target drug Perjeta (Pertuzumab), which is produced by Roche.

EG1206A is a second-generation biosimilar of the HER2-positive target antibody drug Perjeta which has a different binding mechanism to the HER2 receptor and can produce a dual blockade effect. When used in combination with the first-generation Trastuzumab, it has a synergistic effect and is used to treat early and metastatic HER2-positive breast cancer. More... (in Chinese)
GNTbm's Phase Ib/II clinical trial for new liver cancer drug enrolls first patient
2 May, 2023
GNTbm (TW: 7427) announced that its Phase Ib/II clinical trial of its new late-stage liver cancer drug has completed enrollment of the first patient at the China Medical University Hospital. This open and multi-center clinical trial will continue to enroll patients at seven medical centers in Taiwan: National Taiwan University Hospital, National Taiwan University Cancer Center, Taipei Veterans General Hospital, Chang Gung Memorial Hospital (Lin-Kou, Kaohsiung and Linkou Branches), and Chi Mei Medical Center. More... (in Chinese)
Asus smart watch blood pressure software receives TFDA approval
2 May, 2023
Computer giant Asus has been making inroads in smart healthcare in recent years. Its Asus blood pressure App which focuses on combining mobile devices, has recently been approved by Taiwan's Food and Drug Administration (TFDA) and has obtained a medical device software license, becoming Taiwan's first self-developed wearable blood pressure application software.

The app uses the time difference of signals collected by the fingertip electro-optical dual sensors of the company's VivoWatch to calculate the flow rate of blood in the arterial vessels and the pressure conditions in the blood vessel when the heart beats. According to internal testing, the accuracy is optimized by more than 12% compared to a single sensor, and it also meets international standards for non-invasive blood pressure monitors such as AAMI/ANSI/ISO 81060-2. More... (in Chinese)
Oneness Biotech's scar cream to be sold in Europe
14 April, 2023
Oneness Biotech (TW: 4743), announced that its Bonvadis cream for scar treatment had obtained a first-class medical device import license in the European Union and will be launched in the EU market. The next step for Oneness Biotech is to submit a wound medical device indication application to the European Union for this product.

The company stated that it is adopting a dual-channel strategy of pharmaceutical and medical devices, with its products complying with respective regulations in both to achieve early access to international markets. Currently, the company's diabetic foot ulcer cream Fespixon has obtained approval in Taiwan and Singapore, and in other countries still under review or preparing for submission, with Bonvadis obtaining approval in the United States, India, New Zealand, and now the European Union. More... (in Chinese)
Taiwan FDA clears Senhwa's IND to start Phase II COVID-19 therapy trial
1 May, 2023
Taiwan FDA has granted clearance for Senhwa Biosciences' investigational new drug (IND) application to initiate a Phase II clinical trial of Silmitasertib(CX-4945) to treat hospitalised patients with moderate to severe COVID-19. More...
TWi Biotechnology's receives FDA approval to begin Phase I trial for eczema drug
1 May, 2023
TWi Biotechnology (TW: 6610) announced that its newly-developed drug AC-1101 for the treatment of atopic dermatitis (eczema) has been approved by the US FDA for a Phase 1 clinical trial.

TWi Biotechnology is a Taipei-based company focused on the research and development of new drugs for rare diseases. Its strategy is to reposition drug molecules that have already been used in clinical settings to meet the demand for new and effective treatments, particularly for rare diseases that are severe and have no existing therapies. More... (in Chinese)
Taiwan AI Labs announces cooperation with Microsoft, to combine smart medical care with MS Azure cloud and ChatGPT
27 April, 2023
Taiwan AI Labs announced that it has signed a memorandum of understanding (MOU) with Microsoft Taiwan and plans to import a number of AI products into the Microsoft Azure cloud. At the same time, it has released the world's first medical AI model combined with ChatGPT, according to the announcement.

The AI Labs team took its AI image-assisted analysis system (DeepMets) as an example to demonstrate the collaborative application with Microsoft Azure cloud and ChatGPT. DeepMets can deduce brain tumors and symptoms within 30 seconds by analyzing brain magnetic resonance imaging (MRI) images, and provide information such as number, diameter, and volume, allowing clinicians to have a more comprehensive and in-depth basis for subsequent treatment. More... (in Chinese)
Sustainable Health Development in the Post-pandemic Era: Taiwan Can Help
25 April, 2023
Taiwan has not been invited to the World Health Assembly since 2017. Taiwan's inclusion would make the world healthier, more sustainable, and more equitable. More...
Avalue and Biomedica bring AI and HPC together to advance disease screening
25 April, 2023
Avalue Technology Inc., an industrial PC/computer manufacturer, announced a strategic partnership with Biomedica to focus on developing AI-aided disease screening systems by integrating AI intelligence and HPC (high-speed computing).

The partnership will accelerate the digital transformation of the medical field and bring better healthcare services, said Avalue, adding that the company's AI-ready system, which uses Intel's high-end Xeon medical systems and edge computing systems, will support Biomedica's AI disease screening system. More...
Taiwanese entrepreneur develops 'candyceutical' products, ensuring people's access to nutrition
24 April, 2023
Founder and CEO Corina Huang shared in an interview the inspiration and impact of BonchaBio, a company that manufactures 'candyceutical dosage forms' to help people easily consume nutrient supplements. More...
Adimmune wins half of public flu vaccine order
24 April, 2023
Vaccine maker Adimmune Corp yesterday won a government contract to provide 3.49 million quadrivalent influenza vaccines, about half of the total order for 6.99 million shots, making it the biggest winner among five bidders, the Ministry of Health and Welfare said. France's Sanofi SA landed the second-biggest contract for 1.92 million flu vaccines, followed by TTY Biopharm Co Ltd with 864,630 shots and Medigen Vaccine Biologics Corp with 707,420 shots, ministry data showed. More...
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

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