4/25 Taiwan Life Sciences Biweekly Newsletter
2022-04-26 | |
| Taiwan Life Sciences Biweekly | |
| 1. Taiwan company initiates clinical trial of drug to treat COVID 21 April, 2022 The third-phase clinical trial of a drug to treat patients with COVID-19 has officially begun amid a surge in COVID-19 cases in Taiwan, Taiwanese pharmaceutical company PharmaEssentia Corp., the drug's manufacturer, announced Wednesday. Ropeginterferon alfa-2b (Ropeg), a novel long-acting pegylated interferon, was originally approved by the Taiwan Ministry of Health and Welfare as a treatment for patients with polycythemia vera (PV), according to PharmaEssentia. More... (in Chinese) | |
| 2. Senhwa Biosciences to provide new COVID-19 drug free of charge to six hospitals in Taiwan 18 April, 2022 Senhwa Biosciences' (TW:6492) announced that its new COVID-19 drug Silmitasertib, approved by the Taiwan FDA last year, will be used at six local medical medical institutions, with the drug being provided free of charge by Senhwa Bioscience. The six hospitals are National Yang Ming Chiao Tung University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taoyuan Hospital of Ministry of Health and Welfare, Taipei City Hospital Renai Branch, and Cheng Hsin General Hospital. Silmitasertib, an oral dosage drug, has shown significant clinical benefits in patients with moderate symptoms of COVID-19, and can prevent disease progression and accelerate patients' recovery. The drug has also been shown effective against Omicron varients in the latest studies, according to the announcement. More... (in Chinese) | |
| 3. CECC distributes 400,000 rapid test kits 18 April, 2022 The Central Epidemic Command Center (CECC) yesterday distributed 400,000 rapid test kits to areas of Taiwan with the greatest risk of infection, as it reported 1,210 new domestic and 93 imported cases. Taipei, New Taipei City, Taoyuan and Hualien County yesterday each received 100,000 at-home test kits, said Minister of Health and Welfare Chen Shih-chung, who heads the CECC. More... | |
| 4. PharmaEngine's new pancreatic cancer drug obtains approval in China 18 April, 2022 Taipei, Taiwan-headquartered PharmaEngine (TW: 4162) announced last week that it had received new drug marketing authorization from China’s National Medical Product Administration (NMPA) for its ONIVYDE (Annergy) plus 5-FU/LV combination therapy for use in pancreatic cancer patients who had not responded to the standard treatment gemcitabine. According to statistics from the World Health Organization in 2020, pancreatic cancer ranks eighth among the new causes of cancer in China, with 124,994 new cases that year. More... (in Chinese) | |
| 5. Taiwan Smart Healthcare Rises Buoyed by the Pandemic 18 April, 2022 As the pandemic wreaked havoc across the globe, healthcare became vital and in urgent need of tech-enablement to cope with both the surge in caseloads as well as restrictions. To manage this, major electronic technology companies in Taiwan have invested in telemedicine. By leveraging the AI, IoT, 5G and 8K, products have gradually moved from field verifications to actual applications. The resulting no-contact economy and no-gap innovation that are provided by such products have accelerated the transformation of traditional healthcare into smart healthcare. More... | |
| 6. Synmosa Biopharma's liver cancer drug approved for an exclusive one-year sales period 13 April, 2022 Synmosa Biopharma (TW: 4114) announced last week that its liver cancer generic drug Sorafenat (generic of Sorafenib) had obtained an exclusive one year sales license from Taiwan’s Ministry of Health and Welfare (MOHW), during which time the Taiwan FDA will refrain from issuing licenses for other generic drugs in this therapeutic space in Taiwan. Synmosa has been cooperated with the Indian drug company Natco Pharma for the manufacture of this drug. On February 1 this year, the drug was approved for reimbursement at a 20 percent discount compared to the original Bayer drug Nexavar (Sorafenib). On March 29 this year, the Ministry of Health and Welfare approved the exclusive sales period from March 14 2022 to March 13, 2023. More... (in Chinese) | |
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| 7. SyneuRx completes enrolment in Phase II trial of Covid-19 oral antiviral 13 April, 2022 (Press release) SyneuRx™ International (TPEX:6575), a global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system disorders, today announced it has completed enrollment for its phase 2 clinical trial evaluating the efficacy and safety of SNB01 ('Pentarlandir'), a novel COVID-19 oral antiviral candidate. In preclinical studies, Pentarlandir demonstrated preliminary efficacy and an excellent safety profile against Omicron, Delta, and previously identified variants of concern in addition to several influenza viruses. More... | |
| 8. Taiwan buys 700,000 doses of Pfizer's COVID-19 treatment drug Paxlovid 13 April, 2022 Taiwan has purchased 700,000 doses of Paxlovid, an oral antiviral treatment for COVID-19 from pharmaceutical company Pfizer. Health Minister Chen Shih-chung says the first 350,000 doses should come during the second quarter of the year. Pfizer's study results showed that Paxlovid reduced the risk of COVID-related hospitalization or death by 89%. COVID patients can take them orally in the form of a pill. More... | |
| 9. Biochemist receives US 'Pioneer' award 30 March, 2022 Biochemist Wong Chi-huey has received a Chemical Pioneer Award for his outstanding contributions in the field of chemistry, Academia Sinica said in a statement yesterday. The American Institute of Chemistry, a non-profit aimed at advancing chemical science, on March 31 announced that Wong and Alison Butler, a University of California chemistry professor, were this year’s recipients of its annual award. More... | |
| 10. Caliway Biopharmaceuticals announces capital injection, with plans to further develop its fat reduction treatment CBL-514 12 April, 2022 Caliway Biopharmaceuticals, which focuses on the development of new drugs for medical aesthetics and chronic inflammatory diseases, announced last week that its recently completed cash capital injection of NT$786 million will be used to accelerate the clinical development of its fat cell reduction treatment CBL-514 injection in the United States and Australia. Ling Yufang, general manager of Caliway Biopharmaceuticals, said that its CBL-514 injection is the world's first small molecule new drug with a new and unique mechanism to induce apoptosis of fat cells to reduce local fat at the injection site. Additionally, the drug does not cause tissue cell necrosis or damage, and has good drug safety and tolerance record. The Phase IIa clinical trial of CBL-514 injection for non-surgical fat-dissolving indications in medical aesthetic applications was completed in Australia in November 2020, and approved by the US FDA and Australia for a Phase II clinical trial IND in December 2020. It is expected to complete the Phase II double-blind trial in 2023 and apply for the global Phase III clinical trial in 2024. More... (in Chinese) | |
| 11. Local team finds bacterial strain to treat inflammatory bowel disease 12 April, 2022 Researchers at the National Health Research Institutes have discovered a new strain of intestinal bacteria that could help treat and prevent inflammatory bowel disease (IBD). The study led by Kao Cheng-yuan (???), an associate investigator at the institutes’ Immunology Research Center, was published in November last year in the journal Cell Reports. More... | |
| 12. Phase III trial data for Medigen's Enterovirus A71 vaccine published in The Lancet 12 April, 2022 Medigen Vaccine (TW: 6547) last week announced that data for its enterovirus EV71 vaccine Phase III multinational multi-center clinical trial has been published by the prestigious medical journal The Lancet. Medigen Vaccine reported that the Phase III trial is the first multinational multi-center (MRCT) trial for enterovirus EV71 vaccine in the world. The trial started in April 2019 and completed end-of-period unblinding analysis in June 2021. The trial included a total of 3,663 subjects from 2 months to 6 years old. More... (in Chinese) | |
| 13. Researchers plan to transfer rights to Chinese medicine for COVID-19 12 April, 2022 Researchers at Taiwan's National Yang Ming Chiao Tung University (NYCU) who have developed a Chinese medicine formula to suppress COVID-19 are planning to transfer the rights to the product on a non-profit basis, they said at a press conference on Tuesday. More... | |
| 14. UBI Pharma's COVID vaccine receives funding from CEPI for multinational Phase III trial 12 April, 2022 UB-612, the new COVID-19 vaccine from UBI Pharma, had received USD9.25 million funding from the Coalition for Epidemic Prevention Innovations (CEPI) on April 6 through Vaxxinity, a subsidiary of UBI, according to a press release by UBI. The company plans to use the funds to conduct a multi-national, multi-center Phase III clinical trial, following a recent 3,875-person extended clinical Phase II trial of UB-612 and the 1,000-strong supplemental dose extension trial conducted in Taiwan which confirmed that the vaccine showed good immunogenicity and safety. More... (in Chinese) | |
| 15. Fifty-five drug shortages reported in first two months ase 12 April, 2022 Fifty-five instances of drug shortages were reported in the first two months of this year, Food and Drug Administration data showed. The number of drug shortage reports rose from 189 in 2018 to 355 in 2020, before falling to 225 last year. Drugs that have been in short supply in the past two years include cardiovascular drugs, anti-infectives, gastrointestinal medicines, metabolic agents, cancer drugs and immunosuppressants, the agency said in an assessment of the shortages. More... | |
| 16. Ontario Together Fund invests CA$1.9M in Bora Pharmaceutical Services 11 April, 2022 The Ontario government is supporting an investment of more than CA$2.5 million for pharmaceutical manufacturer Bora Pharmaceutical Services Inc. [Bora Pharmaceutical Services is the Canadian subsidiary of Bora Pharmaceuticals Co. Ltd., a publicly traded Taiwanese life sciences company with experience supplying products around the world.] Through the Ontario Together Fund, the province is investing more than CA$1.9 million to help Bora Pharmaceutical Services invest in equipment that will help to grow local pharmaceutical manufacturing capacity, strengthening pandemic preparedness and supporting the life sciences sector. This investment will create 8 new, local jobs. More... | |
| 17. Medeon Biodesign acquires American medical materials company to expand CDMO reach 11 April, 2022 Medeon Biodesign (TW: 6499), a Taipei, Taiwan headquartered medical materials company, announced today that it has acquired Silicon Valley, US-headquartered medical equipment manufacturing company Second Source Medical, through US-based subsidiary. Medeon Biodesign announced it paid NT$235 million (US$8.26 million) for Second Source Medical, and expected the acquisition to fuel the company's CDMO business and market expansion by increasing its manufacturing capacity and customer base. More... (in Chinese) | |
| 18. Proposed Amendment to Taiwan’s Patent Law 11 April, 2022 In the first quarter of 2022, Taiwan's Cabinet submitted to the Congress a proposed Amendment to the Patent Law, aiming at rounding off Taiwan's patent linkage system which was implemented since August 20, 2019. Taiwan's patent linkage system is set forth in Rules 48-3 to Rules 48-22 of the Pharmaceutical Affairs Act. More... | |
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