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5/23 Taiwan Life Sciences Biweekly Newsletter

2022-05-26
Taiwan Life Sciences Biweekly
1. BRIM Biotechnology, Inc. and Ora, Inc. announce new partnership to accelerate the development of regenerative peptide therapy, BRM421, for Dry Eye Syndrome
17 May, 2022
BRIM Biotechnology, Inc.,, a clinical-stage company developing novel regenerative therapies in ophthalmology, today announces it has entered into a new strategic partnership with Ora®, Inc., the world’s leading ophthalmic research organization for the late-stage clinical development of lead drug candidate, BRM421, for dry eye syndrome (DES). BRIM intends to initiate Phase 3 clinical studies with Ora’s support later this year. More...
 
2. SyneuRx’s Pentarlandir Validated as Safe and Effective Drug Candidate for COVID-19
16 May, 2022
Drug development company SyneuRx (TW: 6575) announced that a study verifying the safety and efficacy of its COVID-19 treatment drug candidate Pentarlandir was recently published in ACS Pharmacology & Translation Science, a journal of the American Chemical Society.

SyneuRx stated that Pentarlandir can be used to treat early-stage mild COVID-19 patients and prevent the deterioration of clinical symptoms. In the future, Phase II and III clinical trials, and inspection and registration audits will be conducted. More... (in Chinese)
 
3. OBI Pharma will present clinical research results of three new drugs at ASCO meeting
16 May, 2022
that it would publish posters at the annual meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago in early June showing progress in the development of three cancer drugs targeting Globo H and AKR1C3 antigens.

The three are the anti-Globo H cancer vaccine Adagloxad Simolenin OBI-822, the antibody small molecule ADC drug complex OBI-999, and the first chemotherapeutic drug targeting AKR1C3 OBI-3424. More...
 
4. Taiwan FDA reviewing data on Novavax vaccine following EUA request
14 May, 2022
Taiwan's Food and Drug Administration (FDA) on Saturday said it was reviewing the technical data on the Novavax COVID-19 vaccine following the American drugmaker's recent request for emergency use authorization (EUA) in Taiwan. More...
 
5. Taiwan Pushes Ahead with Domestic Vaccines
14 May, 2022
More than two million doses of Medigen’s MVC-COV1901 have been administered domestically, but it has yet to gain traction internationally. Meanwhile UBI Pharma’s UB-612 is pending emergency-use authorization in Taiwan. More...
 
6. Taiwan’s TCM COVID Treatments Show Promise
13 May, 2022
Since the pandemic began, Taiwan has developed several herbal formulas that traditional Chinese medicine doctors say are effective in treating COVID-19. The most prominent of these is Taiwan Chingguan Yihau (NRICM101), marketed under the name Respire Aid and developed by Taiwan’s National Research Institute of Chinese Medicine (NRICM). More...
 
7. Bora Pharmaceuticals acquires CDMO assets from Eden Biologics
12 May, 2022
Taiwan-based CDMO, Bora Pharmaceuticals, says the acquisition of CDMO assets from local player, Eden Biologics, will help it build a presence in large-molecule contract drug development and manufacturing. More...
 
8. Formosa Pharmaceuticals and AimMax Therapeutics Announce Successful Top-Line Results from CPN-301 for the Treatment of Inflammation and Pain after Cataract Surgery
12 May, 2022
Formosa Pharmaceuticals, Inc. (TWO.6838) and AimMax Therapeutics, Inc. (United States) report successful top-line results from CPN-301, the first of two pivotal Phase 3 clinical studies of APP13007, a novel ophthalmic nanosuspension formulation of a potent corticosteroid, clobetasol propionate(0.05%), for the treatment of inflammation and pain after cataract surgery. More...
 
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9. The National Institutes of Health and Taiwan's Eli Lilly sign cooperation agreement to jointly promote precision medicine
11 May, 2022
Taiwan's National Health Research Institutes (NHRI) and the Taiwan branch of Eli Lilly announced last week that they had signed a cooperation agreement to jointly develop precision medicine projects. In the agreement, Eli Lilly Taiwan will join the NHRI to develop treatment strategies for cancer patients through resource integration and data sharing.

Hidehito Katsuma, general manager of Eli Lilly Taiwan, said that as a partner in Taiwan's healthcare ecosystem Eli Lilly is delighted to work with NHRI to promote personalized medicine so that cancer patients, healthcare providers and the entire healthcare system can benefit. More... (in Chinese)
 
10. Meet Elbert Man of Bristol Myers Squibb
10 May, 2022
Bristol Myers Squibb (BMS) Taiwan General Manager Elbert Man’s people-centric outlook on life and work is a perfect match for the pharmaceutical industry. Man emphasizes transparency, respect for boundaries, and healthy debate as essential to fostering high-performing teams, a philosophy that has helped him advance through several country manager roles at international pharma companies. More...
 
11. Tanvex BioPharma ASCO Annual Meeting Announced the Latest Test Results of TX05
9 May, 2022
Tanvex BioPharma (TW: 6541) in a recent announcement said that it will participate in the 2022 American Society of Clinical Oncology (ASCO) annual meeting to be held in Chicago in early June and will give oral and poster presentations on the latest study results of its breast cancer biosimilar drug TX05.

TX05 is the second biosimilar drug developed by Tanvex for the treatment of breast cancer. The company said that if all goes well it expects to obtain US FDA drug approval within this year. More... (in Chinese)
 
12. Preventing Intraoperative Complications with AI
9 May, 2022
The use of artificial intelligence (AI) technologies in critical care has potentially lifesaving outcomes for long-term disease prevention and critical decisions during surgery. AI technologies can help medical professionals find biomarkers of disease, identify target molecules, discover drug candidates, speed up clinical trials, and even monitor and predict epidemic outbreaks. More...
 
13. NaivFUS NAVIRFA Scope gains regulatory approval from Taiwan FDA and US FDA, aims to begin sales in second half of 2022
9 May, 2022
(Press release) On May 9th, 2022, NaviFUS Corporation (TW: 6872), an innovator of focused ultrasound technology announced that its NAVIRFA® Scope product has consecutively received approvals for the Sales License for Class II Medical Device from TFDA (Taiwan Food and Drug Administration) and the 510(K) Premarket Notification from US FDA in early May. NaviFUS announced that it expects to begin sales of NAVIRFA® Scope on the Taiwan market with Unipharma as its distributor in the second half of this year. At the same time, it will also start new product development for the NAVIRFA® Scope on dendritic cell (DC) immunotherapy to help treat liver cancer patients. More...
 
14. TaiMed Biologics’ new AIDS drug to launch in the second half of the year
9 May, 2022
TaiMed Biologics (TW: 4147) announced that the intravenous dosage form of its AIDS drug Trogarzo is expected to be approved by the US FDA in the second half of the year, with the intramuscular injection dosage form for home use expected to be cleared by the end of the third quarter.

The company mentioned that the COVID-19 pandemic had affected its financial performance last year, while Q1 revenue of NT$40 million shows a year-on-year decrease of 55.4 percent. But with inventory adjustment, new products and new manufacturing resources coming online soon, gross profits are poised to go higher.

Trogarzo intravenous injection to date has obtained drug approval in Europe and the United States, and is marketed in more than 30 countries including Israel, Norway, Russia and Switzerland. More... (in Chinese)
 
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