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5/22 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
Moderna: A Shot in the Arm for Taiwan's Pharmaceutical Industry
16 May, 2023
Little more than two years ago, Moderna was an unknown company to many, despite the company's founding in 2010. But due to the pandemic, the American vaccine developer has become a household name around the world, and one of the most desirable places to work.

"It's a privilege that although we are a startup, every Taiwanese person knows us, " says General Manager for Taiwan and Hong Kong Joyce Lee, who became the company掇 first employee in Taiwan in September 2022. Moderna is known for fostering an entrepreneurial spirit among its more than 3,900 employees worldwide ?many of whom were onboarded in batches at the company掇 headquarters in Massachusetts. More...
Taiwan Advanced Nanotech and Advantech to cooperate in cell therapy equipment
16 May, 2023
Taiwan Advanced Nanotech (TW: 6797) announced that it had entered into a strategic partnership with electronics company Advantech (TW: 2395) to jointly produce the next generation of disposable multifunctional bio-extraction instruments with automatic magnetic bead cell separation capabilities. Mass production will begin in July, aiming to seize the global cell therapy market. Taiwan Advanced Nanotech stated that global patent protection for the new product has been applied for, with the initial focus on European and South American customers, and an emphasis on local production of nucleic acid reagents. More... (in Chinese)
Tanvex BioPharma Enters Exclusive Distribution Agreement for Nypozi (filgrastim) in Canada
Press release
16 May, 2023
Tanvex BioPharma, Inc., has announced that its subsidiary, Tanvex BioPharma USA, Inc. has entered into a distribution agreement with Sandoz AG for Nypozi (filgrastim) in Canada. Under the terms of the deal, Tanvex will receive an upfront payment, payments for supply and contingent payments based on sales and profit from the product. All other terms of the agreement are confidential. More...
StemCyte inks cooperation agreement with Cytoimmune Therapeutics
15 May, 2023
StemCyte announced on 12 May that it has signed a cooperation agreement with Cytoimmune Therapeutics, a US-based immune cell therapy company, to supply Cytoimmune with the cellular materials needed for the development of allogeneic cell therapy products worldwide. StemCyte is headquartered in Taiwan.

Headquartered in California, Cytoimmune was founded by Michael Caligiuri, the current president of City of Hope National Medical Center, and its major investors include Warren Buffett. Cytoimmune is the international leader in CAR-NK allogeneic immune cell products using cord blood cells. More...
Lumosa Therapeutics wins entry ticket to European market with approval from Ukraine
15 May, 2023
Lumosa Therapeutics (TW: 6535) announced that its long-acting analgesic, LT1001, had obtained import drug market approval from the State Service of Ukraine on Medicines and Drugs Control (SMDC), making its first entry into the European market, after already obtaining drug licenses in Taiwan, Singapore, Thailand, and Malaysia. The company also mentioned that its drug license applications in South Korea and Jordan are also progressing rapidly. More... (in Chinese)
Tanvex BioPharma biosimilar TX 01 makes approval progress in Canada, US
14 May, 2023
Tanvex BioPharma (TW: 6541) announced that its biosimilar TX 01 (trade name NYPOZI) had been approved for reimbursement in Canada, with the company intending to sign sales agreements with local pharmaceutical companies in the second quarter and aiming to officially launch in Canada before the end of the year. In the US, a marketing application was submitted to the US FDA at the end of April, with the aim of obtaining drug approval in the fourth quarter of this year.

TX 01 is indicated for chemotherapy-induced neutropenia. The reference drug is NEUPOGEN by Amgen. The Canadian market is estimated to be worth US$70 million annually, and Tanvex's initial goal is to achieve a 5 percent market share, reaching 10 percent within three years. The US market size is approximately US$384 million. More... (in Chinese)

TaiMed Biologics announces development updates to its anti-HIV long-acting combination drug
11 May, 2023
TaiMed Biologics (TW: 4147) held a shareholder meeting to announce updates to the development of its long-acting combination anti-HIV drugs, TMB-365 and TMB-380. James Chang, CEO of TaiMed Biologics, said that the safety and PK data of the Phase Ib clinical trial of TMB-365/TMB-380 is expected to be released in September this year, with efficacy data from the Phase IIa trial to be released in the second half of next year. At that time, international market authorization will be officially launched.

TaiMed Biologics is the only biotech company in Taiwan developing new anti-HIV drugs. Its first-generation drug, Trogarzo (TMB-355), has been on the market in the United States since 2018, and the company is actively expanding into European markets. However, Trogarzo as a second-line treatment for HIV currently only treats around 300 patients per year in the US. More... (in Chinese)
BRIM plans to launch a new funding round to accelerate late-stage clinical trial and initiate a new phase 2 trial for orphan drug BRM424 in the U.S
Press release
10 May, 2023
BRIM Biotechnology, Inc. ("BRIM," TPEx 6885), a clinical-stage biotechnology company focusing on developing regenerative peptides for ophthalmology and degenerative joint diseases, announced today that the Board of Directors has approved a seasoned equity offering that will issue 20 to 22.5 million shares of new stocks priced at 60-80 New Taiwan Dollars (USD 2-2.67) per share. A total of NTD 1.2 to 1.8 billion (USD 40-60 million) will be raised to accelerate the development of several assets within its pipeline including the current Phase III trial of lead asset BRM421 for dry eye disease (DED) in the US, and speed up the enrollment of the Phase II trial of BRM424 for neurotrophic keratitis (NK). BRIM will also progress the development of BRM521 for osteoarthritis while also assessing new projects. More...
NaviFUS joins hands with Bracco to co-develop drug delivery to the brain
9 May, 2023
In order to break the blood-brain barrier for drug treatment, NaviFUS Corp. announced that it has signed a licensing agreement with Bracco, the world's leading ultrasound contrast brand, to develop a microbubble product to be used in conjunction with the NaviFUS system for drug delivery to the brain, and the microbubble product will be included in the first recurrent brain tumor (rGBM) trial being prepared by NaviFUS. More...
Fat accumulation, inflammation are risk factors in adipose-derived mesenchymal stem cell therapy for pulmonary fibrosis, according to new research
8 May, 2023
Adipose-derived mesenchymal stem cell therapy may have the risk of fat accumulation. Regenerative medicine is an important trend, but the joint research between Yangming Jiaotong University and Taipei Veterans General Hospital found that adipose-derived mesenchymal stem cells, which are widely used in clinical practice, have abnormal fat generation and accumulation in the treatment of pulmonary fibrosis. Fat accumulation can promote the secretion of inflammatory factors, which is known to be related to many diseases. More... (in Chinese)
PharmaEssentia announces Asian market approval progress
8 May, 2023
PharmaEssentia (TW: 6446) announced that it has two major updates to its pathway to approval in Asian markets for its new drug Ropeginterferon alfa-2b (Ropeg) for the treatment of polycythemia (PV). First, the company was notified by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia to officially accept Ropeg for treatment of PV; in addition, PharmaEssentia filed an application for marketing authorization in Hong Kong.

PharmaEssentia also pointed out that since Ropeg obtained the Japanese PV drug certificate at the end of March this year, the Japanese team is conducting pre-marketing activities and preparations for the supply chain and sales channels, and is discussing drug instructions and label details with the Japanese regulatory body the Pharmaceuticals and Medical Devices Agency (PMDA). Japan is the third largest drug market in the world, and Ropeg is expected to be launched in Japan in the third quarter of this year. More... (in Chinese)
StemCyte to begin Phase II clinical trial in the US for long COVID-19 treatment RegeneCyte
8 May, 2023
Taiwanese cord blood and tissue banking company StemCyte announced that its allogeneic cord blood cell therapy drug, RegeneCyte, for the treatment of long COVID-19, has officially been accepted for Phase IIA human clinical trials in the United States. This is the first Phase II clinical trial worldwide using cord blood cells for the treatment of long COVID-19. The trial aims to recruit 30 participants and is expected to be completed in the first half of next year.

According to StemCyte CEO, Lee Dong-yang, this prospective clinical trial encompasses several global firsts. Firstly, it is the first Phase II clinical trial using cord blood cells approved by the US Food and Drug Administration (FDA) for the treatment of long COVID-19. Secondly, it is also a clinical trial using cord blood cells for the treatment of chronic fatigue. Thirdly, it is the first FDA-approved clinical trial design that provides multiple doses of cord blood cell therapy to the same patient. More... (in Chinese)
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. (6838.TWO) and AimMax Therapeutics, Inc. (United States) announce the submission of a New Drug Application to the United States Food & 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...
Taiwan Bio Industry Organization (Taiwan BIO)
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