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9/25 Taiwan Life Sciences Biweekly Newsletter

Taiwan Life Sciences Biweekly
Ever Supreme's allogeneic CAR-T greenlighted for Phase I/II trial
22 September, 2023
Ever Supreme Bio Technology announced a major breakthrough in cell therapy. The US FDA has recently approved the company's CAR001 (CAR-T) to undergo Phase I/IIa clinical trial, which is one of the few cases in the world where allogeneic CAR-T cells have been used to target solid tumors. In the future, Ever Supreme will have the opportunity to seize the global tens of billions of dollars of cell therapy business opportunities. More...
ACRO Biomedical Teams up with DKSH to Enter the Medical Device Market in Vietnam
21 September, 2023
ACRO Biomedical (TW: 6748), a regenerative medicine company, reached an international cooperation agreement with the Switzerland-headquartered global medical device distributor DKSH in Vietnam on 20 September. DKSH has been approved as the exclusive distributor for ACRO Biomedical's wound care, dental, orthopedic, and major surgical products in Vietnam. More... (in Chinese)
Drugs made in Taiwan snag and expect more market approvals
19 September, 2023
Taiwan's pharmaceutical companies are maturing, and this year has brought good news regarding new drug approvals from several biopharmaceutical companies, including Polaris Pharmaceuticals, Panion & BF Biotech (PBF), Formosa Pharmaceuticals, Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm), and more. However, the most significant development is the progress made by Oneness Biotech in the development of its diabetic foot ulcer drug, Fespixon.

Oneness's Fespixon was officially included in Taiwan's National Health Insurance (NHI) coverage starting in August this year, and it has been looking to attain regulatory approval in China later this year. More...
Diamond Biofund Announces Partnership with CHO Pharma for New Drug Development
19 September, 2023
Diamond Biofund (TW: 6901) officially went public on 19 September, and on the eve of its listing the company announced a significant partnership with CHO Pharma, a new drug company jointly invested in by Diamond Biofund and Taiwan's Academia Sinica. Additionally, they intend to collaborate with famed Taiwanese immunologist Tse Wen Chang to develop a higher-tier, next-generation Antibody-Drug Conjugate (ADC) medication with global applicability. Industry observers anticipate that this partnership could potentially challenge new records in licensing fees. More... (in Chinese)
Caliway Announces the Completion of Subject Recruitment in the CBL-0201EFP Phase 2-stage 2 Study Evaluating the CBL-514 in Cellulite Treatment
19 September, 2023
aliway Biopharmaceuticals (Caliway), a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage 2 study. More...
J&J Janssen and MedTech: Advancing Healthcare Innovation, Together
19 September, 2023
"Healthcare innovation is blurring the lines between pharmaceuticals and medical technology," says Miyuki Ogushi, Managing Director of Janssen Taiwan, Pharmaceutical Companies of Johnson & Johnson. "This realization sparked a dialogue on how we could amplify our collaboration and find multifaceted solutions to current and future healthcare challenges based on our innovations." More...
Taiwan Excellence Drives Future Telemedicine with Cutting-Edge Innovations
19 September, 2023
"Medical Fair Thailand 2023", a global exhibition showcasing the latest medical products and technologies, has once again set a high standard for the medical industries. This prestigious event welcomed Taiwan Excellence, renowned for its research, development, and innovative design capabilities. Fifteen award-winning Taiwanese companies from Taiwan Excellence presented their tailor-made innovations, catering to the specific needs of the smart healthcare, biotechnology, and medical industries. More...
PharmaEngine Tops New Drug Sales with Pancreatic Cancer Medication, Selling Over NT$10 Billion Globally Last Year
18 September, 2023
The National Development Council in its analysis of the top ten best-selling new drugs by a Taiwanese company, first place is held by PharmaEngine (TW: 4162) for its pancreatic cancer drug ONIVYDE, selling NT$10.11 billion worldwide last year. More... (in Chinese)
EirGenix's Cancer Biosimilar Receives European CHMP Recommendation, Expected to Launch in Q4 2023
18 September, 2023
EirGenix (TW: 6589) announced that its biosimilar drug EG12014 (Trastuzumab Biosimilar 150 mg intravenous) for breast and gastric cancer, licensed to Sandoz AG, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) earlier this month. It is expected that this drug is likely to be launched in the European Union in the fourth quarter of this year. More... (in Chinese)
Merry Life Biomedical's Alzheimer's Drug to Begin Phase I Clinical Trial Next Year
18 September, 2023
Medeon Biodesign (TW: 6499) is celebrating a breakthrough in its medical device development. Its thoracic aorta repair medical device, Duett, has received approval for clinical trials from the US FDA. The trial is expected to enroll 20 patients initially, with the possibility of expanding the scale of clinical trials upon approval. The data collected from this trial, which will evaluate clinical outcomes over 30 days, will serve as the primary trial indicator for subsequent registration applications. More... (in Chinese)
Tanvex BioPharma and OBI Pharma collaborate in new drug development
18 September, 2023
Tanvex BioPharma and OBI Pharma announced that they are working together in new drug development. Although the two companies have different strategies in the field of antibody-drug conjugates (ADC), they will ultimately complement each other, according to a joint announcement. Tanvex already has a biosimilar drug TX01 for treating neutropenia expected to receive regulatory approval in Q4 2023. The company is currently a ADC contract development and manufacturing organization (CDMO) and has already received orders. In September, Tanvex Taiwan launched a new website, focusing on CDMO services as a core offering, employing an online-to-offline (O2O) integrated strategy, demonstrating its commitment to the CDMO market.

OBI Pharma has two new drugs in its ADC portfolio; OBI-999 having entered Phase II clinical trials, and the highly anticipated TROP2 antibody R-992, expected to apply for human clinical trials by the end of the year. Progress has also been made in the global Phase III clinical trials of the breast cancer drug OBI-822. More... (in Chinese)
Lotus and Adalvo launch Gabapentin ER in South Korea
Press release
18 September, 2023
Leading global pharmaceutical company, Lotus Pharmaceutical (1795:TT), joins hands with the leading B2B pharma player, Adalvo, to proudly announce the introduction of Gabapentin ER 300 / 600 mg in South Korea.

This 505b(2) product, derived from the reference brand Neurontin Hard Capsule 300mg and Neurontin Film Coated Tablet 600mg, is designed to provide long lasting relief to individuals grappling with Postherpetic Neuralgia (PHN). PHN, a debilitating condition, can significantly diminish one's quality of life. Gabapentin ER, with its convenient once-daily dosing regimen, offers meaningful improvement of patient convenience. More...
Nobel laureate Carolyn Bertozzi joins [Taiwan-listed] Acepodia as biotech aims to transform cancer cell therapy
18 September, 2023
Acepodia has snagged Nobel laureate Carolyn Bertozzi, Ph.D., to serve as chief scientific adviser as the biotech works to transform the cell therapy space for patients with solid tumors and hematologic cancers. More...
Taiwan makes waves with revolutionary cancer treatment center
14 September, 2023
Taiwan, already acknowledged globally as a leading hub for semiconductor manufacturing, is now making waves for its groundbreaking cancer treatment facility. The island nation's first Heavy Ion Therapy Centre (HITC) in Taipei, constructed at a cost of US$150 million, is now actively treating Stage One and Two cancer patients. The center, the first of its kind outside Japan, focuses on painless and targeted radiotherapy treatment using ion radiation therapy, and boasts a higher recovery rate in a shorter time. More...
Orient Pharma's ADHD drug makes inroads into Thailand
13 September, 2023
Orient EuroPharma's (TW: 4120) subsidiary, Orient Pharma (TW: 4166), announced that they have signed a partnership agreement with B.L. HUA in Thailand to launch their ADHD (Attention Deficit Hyperactivity Disorder) new drug, Methydur, in the Thailand market, marking the first entry of Orient EuroPharma's products into this market. With the prevalence of ADHD in Thailand approximately 4.2 to 8.1 percent, there is promising growth potential for this drug in this market. More... (in Chinese)
Taiwan and UK announce drug assessment data sharing cooperation
13 September, 2023
Taiwan's Ministry of Health and Welfare's National Health Insurance Administration (NHIA) held a Taiwan-UK Medical Technology Assessment Collaboration Agreement Workshop, engaging in discussions with the National Institute for Health and Care Excellence (NICE) from the United Kingdom. Discussions focused on clinical trials and real-world data collection mechanisms for emerging technologies such as gene therapy and cell therapy. In the future, the two countries plan to share relevant data to expedite the assessment of the effectiveness of new drugs. This effort aims to allow temporarily reimbursed drugs with unsatisfactory performance to exit early from the system, thus aiding in concentrating health insurance resources on expanding reimbursement for effective new drugs. More... (in Chinese)
ASUS AICS and National Taiwan University Hospital build smart healthcare ecosystem with privacy protections
13 September, 2023
ChatGPT, the latest artificial intelligence (AI) trend, has continued to create surprises in our daily lives. The trend has naturally spread to the field of medicine which generates a wave of new smart healthcare applications that combine biomedicine with AI. The development has driven massive growth in biomedical technology which drastically reduces the analysis and interpretation time, thereby increasing the accuracy and efficiency of diagnosis. The AI-oriented medicine is creating new opportunities as smart technology has become an indispensable force that drives the development of biomedical science. More...

Digital healthcare focus of Taipei APEC workshop
13 September, 2023
Representatives from 10 APEC economies yesterday attended a National Health Insurance Administration (NHIA) event in Taipei to discuss how to improve digital healthcare data applications.

The APEC Workshop on Public-Private Collaboration in Supporting of Containing Measures During and Beyond Pandemic consisted of three sessions: Innovative care or delivery models developed by digital health technologies, Principles of heath data management and Case sharing on public-private healthcare collaboration. More...

BRIM Biotech closes a US$45.8 million rights issue
13 September, 2023
Taiwan-based BRIM Biotechnology (TW 6885) today announced that 22,500 shares have been issued at a premium of NT$65 (US$2.03), raising a total of NT$1.4625 billion (US$45.8 million). More...

TaiRx poised to out-license oral anticancer drug CVM-1118
13 September, 2023
Mr. Andrew Lin, Chairman of TaiRx, Inc., said yesterday (12 Sep) that TaiRx's new oral anticancer drug CVM-1118 (Foslinanib), targeting neuroendocrine tumours, has already recruited more than half of the Phase II clinical cases, which can be completed ahead of schedule by the end of this year, and that after the release of clinical data in the middle of next year, it will have the opportunity to complete the international licensing by the end of next year, and that TaiRx is planning to apply for a public listing through Taipei Exchange in 2025. More...

Exploring AI's Impact on Biotech Breakthroughs and International Funding
Press release
12 September, 2023
During BIO Asia-Taiwan 2023, GeneOnline and Ching Cheng Attorneys at Law jointly held a Biotech Month Forum, with the theme of "From AI to cross-border funding: Unlocking Success for Biotech Companies". Experts from various fields exchanged views on issues such as the pivotal role of artificial intelligence (AI) in drug development, the intriguing notion of AI's ownership of intellectual property, and the intricate process of securing international funding, with the aim of in-depth exploration of how the burgeoning growth of big data and AI is shaping the biotech industry. More...

Taiwan's biotech gains growth momentum with M&A
Press release
11 September, 2023
Biotechnology companies in Taiwan are gaining momentum again through M&A and buying stakes. Bora Pharmaceuticals, TCI Co., and ShinyBrands, aiming at the hundreds of billions of dollars of business opportunities in beauty and personal care products, have merged and acquired shares in new companies. Genomics, BiOptic, and TCI Gene are targeting the gene sequencing market. 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

BIO Asia-Taiwan July 24-28, 2024

Taiwan Bio Industry Organization (TBIO)
Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd.,
Nangang Dist., Taipei, Taiwan (11571)