1/6 Taiwan Life Sciences Biweekly Newsletter
2025-01-06 |
| Taiwan Life Sciences Biweekly |
| Handa Pharmaceuticals ventures into blood cancer drugs 2 January, 2025 Handa Pharmaceuticals (TW: 6620) announced that it will acquire the oral kinase inhibitor Phyrago (Dasatinib) for USD30 million (approximately TWD983.55 million). This FDA-approved drug is used for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The company stated that following the acquisition of the drug's ownership, the company plans to launch it into the market in the first half of this year, targeting a USD900 million annual market opportunity. More... (in Chinese) |
| PharmaEssentia's 2024 stock price up over 70 percent, global Phase III results for blood cancer drug to be released soon 1 January, 2025 PharmaEssentia (TW: 6446) saw an increase of over 70 percent in its stock price in 2024, with its three major institutional investors purchasing a net total of 27,000 shares, the highest among biotech and medical stocks listed on the Taiwan stock exchange. Additionally, the company's blood cancer drug Ropeg, used to treat essential thrombocythemia (ET), is expected to release the results of its global Phase III clinical trial in the first quarter. If the results are favorable, the drug may be launched in 2026. More... (in Chinese) |
| Foresee Pharmaceuticals' prostate cancer drug new formulation enters substantive review phase in the US 29 December, 2024 Foresee Pharmaceuticals (TW: 6576) announced that the US New Drug Application (NDA) for its newly developed 3-month formulation of the prostate cancer drug CAMCEVI has entered the substantive review phase. If approved, it will become another key prostate cancer treatment in its portfolio, following the previously launched 6-month formulation of CAMCEVI. More... (in Chinese) |
| Genomics and Illumina sign MOU to deepen collaboration in three areas 26 December, 2024 Gene sequencing company Genomics (TW: 4195) announced the signing of a strategic Memorandum of Understanding (MOU) with global gene sequencing leader Illumina. The two parties will engage in collaboration in three key areas: Establishing a top-tier gene sequencing center in the Asia-Pacific region; Promoting multi-omics applications in Taiwan; Commercialization of gene sequencing solutions, focusing on jointly developing models and optimized solutions for the commercialization of gene sequencing technologies. More... (in Chinese) |
| Vizuro and DCB Join Forces to Revolutionize Drug Discovery and Precision Medicine with Causal Generative AI Press release 26 December, 2024 Vizuro LLC, a leading innovator in multimodal causal AI technology, and the Development Center for Biotechnology (DCB) announced the signing of a Memorandum of Understanding (MOU) to collaboratively drive innovation and growth in the biotechnology and pharmaceutical industries. This collaboration aims to establish a next-generation AI computational platform, advancing breakthroughs in drug discovery and accelerating the implementation of precision medicine. The partnership paves the way for groundbreaking advancements in the global biotech industry. More... |
| Senhwa Biosciences' new drug in clinical trials 26 December, 2024 Senhwa Biosciences (TW: 6492) held a recent investor conference emphasizing its recent focus on the clinical validation of two first-in-class new drugs, Pidnarulex (CX-5461) and Silmitasertib (CX-4945). The company is also actively pursuing out-licensing and international collaboration initiatives. Pidnarulex, a monotherapy in clinical trials for advanced solid tumors, is garnering significant attention for its development under the US National Cancer Institute's (NCI) five-year NExT program, which provides support in funding, regulatory guidance, and expertise. More... (in Chinese) |
| AI-Powered Drug Development: How NVIDIA Builds a Balance Between Biotech and TechBio 26 December, 2024 The Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO), Development Center for Biotechnology (DCB), NVIDIA, and Taiwan Industrial Technology Association (TITA) collaborated to organize the "Symposium on Generative AI for Drug Development and Precision Medicine". Held on December 19 at Taipei Bioinnovation Park, the event was co-organized by GeneOnline and attracted over 1,000 registrations, both in-person and online. The symposium brought together more than 300 guests from the biotech, technology, medical, and academic sectors, along with institutional investors, to participate at the venue. More... |
| TAHO Pharmaceuticals' new anti-thrombosis drug aims for drug approval application 26 December, 2024 TAHO Pharmaceuticals (TW: 6467), a company specializing in anti-thrombosis oral dissolving films, buccal dissolving films, and transdermal patch products, plans to list on the Taipei Exchange on December 30th with a reference price of NTD56 per share. The company stated that the anti-thrombosis oral dissolving film drug TAH3311, currently in Phase III clinical trials, is expected to be completed in the first quarter of next year. The drug's regulatory applications for approval in the US and Europe will be submitted in the third quarter, with licensing agreements in Europe and the US likely to be finalized. The goal is to obtain approval by Q4 of 2026 and target a global market worth over US$22 billion. More... (in Chinese) |
| Shine-On Biomedical licenses exosome-based drug technology to Singapore's ESCO Aster Press release 25 December, 2024 Shine-On Biomedical (TW: 6926), a regenerative medicine company, recently announced the signing of a Memorandum of Understanding (MOU) with Singapore's ESCO Aster, a clinical-grade exosome company, for the licensing of Shine-On Biomedical's HLA-G-targeted exosome drug delivery platform and a collaboration for product development. The partnership aims to accelerate the development of exosome-based technologies for loading anti-cancer drugs, creating new cancer treatments that are more effective and have fewer side effects, addressing the challenges of severe chemotherapy side effects. Under the terms of the agreement, Shine-On will receive NT$150 million in upfront and milestone payments, as well as 5 percent royalty revenue on product sales. More... (in Chinese) |
| Oneness Biotech exceeds R&D goals, breaks into international arena 25 December, 2024 With Oneness Biotech (TW: 4743) recently facing a sharp drop in its stock price, founder William Lu personally hosted an investor conference to reveal recent developments for his company. He stated that the company has surpassed its R&D goals for the year, with six products under active development. The drug Fespixon for the treatment of diabetic foot ulcer has already been launched in Singapore, Malaysia, and mainland China, marking its official entry into the international market. More... (in Chinese) |
| PharmaEssentia's blood cancer drug aims for Phase III clinical trials 25 December, 2024 PharmaEssentia (TW: 6446) attended a conference on December 25th to discuss its outlook for 2025. The company stated that its primary goal is the global Phase III clinical trial for its blood cancer drug, Ropeg, used to treat essential thrombocythemia (ET). The company plans to announce key efficacy indicators and data collection early next year. If the results are successful, the drug may be launched in 2026. The market size for ET treatment is expected to surpass that of PharmaEssentia's currently marketed drug for polycythemia vera (PV). More... (in Chinese) |
| EirGenix submits Phase III clinical trial plan to US FDA for biosimilar drug EG1206A 24 December, 2024 EirGenix (TW: 6589) announced that the clinical trial plan for its investigational biosimilar drug EG1206A (pertuzumab biosimilar) has been successfully submitted to the US FDA. EG1206A is used for the treatment of early-stage and metastatic breast cancer. More... (in Chinese) |
| Mycenax will reach a new milestone next year, becoming the manufacturer of two internationally approved drugs 24 December, 2024 Mycenax (TW: 4726) stated that since transforming into a professional biopharmaceutical CDMO (Contract Development and Manufacturing Organization) company in 2019, it has seen the number of collaborative projects grow by more than twofold. With clients' drug registrations and market launch plans, Mycenax is expected to enter the next phase starting in 2025, becoming an international market supplier for two approved biopharmaceuticals, thereby establishing a stable foundation for future revenue growth. More... (in Chinese) |
| GlycoNex's biosimilar SPD8 enters Phase III clinical trials and successfully out-licenses 24 December, 2024 GlycoNex (TW: 4168) announced that it has successfully signed an out-licensing agreement for SPD8, a biosimilar to the antibody drug Denosumab. The authorized partner will have the rights to develop, apply for approval, and commercialize SPD8 in specific markets. GlycoNex will also receive milestone payments based on the progress of product development and commercialization. Denosumab is used for the prevention of osteoporosis and bone metastasis from solid tumors. After successfully completing Phase I clinical trials and confirming its safety and pharmacokinetic equivalence, SPD8 officially entered Phase III clinical trials in December this year, with the first patient enrolled. More... (in Chinese) |
| BIONET forms strategic alliance to accelerate exosome overseas business expansion 23 December, 2024 BIONET (TW: 1784) has combined its subsidiary Genetics Generation Advancement (TW: 4160) and BIONET Therapeutics (TW: 7808) to exclusively apply AI systems for analyzing miRNA expression levels in the research and development of exosome functions. The company is investing in various indications and different skincare needs, using AI-developed exosomes to identify the optimal exosome combinations. In addition to strategic alliances with medical institutions, medical aesthetics, cosmetics development, and medical equipment, BIONET is accelerating its entry into the regenerative medicine field. The company is also promoting its Exosome Foundry (a global exosome R&D center for contract manufacturing) business model, actively expanding into overseas markets such as Malaysia, Thailand, Indonesia, and Japan. More... (in Chinese) |
| Taiwan Bio Therapeutics applies for US clinical trial 23 December, 2024 Taiwan Bio Therapeutics (TW: 6892) announced that its investigational allogeneic cell therapy drug MSC/VEGF for treating critical limb ischemia has been submitted for an Investigational New Drug (IND) application to the US FDA. It is the world's first allogeneic gene-modified cell therapy new drug targeting severe chronic diseases. Taiwan Bio Therapeutics stated that if no notification is received within 30 days of the FDA's acceptance of the application, the review will be deemed approved, and the clinical trial can proceed. More... (in Chinese) |
| OBI Pharma enters collaboration with GlyTech to expand GlycOBI enabling technologies Outreach in Japan and to advance glycan production 23 December, 2024 Press release OBI Pharma, Inc. (TW: 4174), a clinical-stage global oncology company specialized in the development of novel cancer therapies such as antibody-drug conjugates (ADC) and active immunotherapies, and GlyTech, Inc., a Japanese manufacturer that focuses on glycan production and chemical glycosylation technologies, have entered into a Marketing Agreement and a Material Transfer Agreement. More... |
| Handa Pharmaceuticals partners with ScinoPharm Taiwan to expand market for improved new drugs 19 December, 2024 Active pharmaceutical ingredient manufacturer ScinoPharm Taiwan (TW: 1789) announced that it will participate in a private placement by Handa Pharmaceuticals (TW: 6620). The two parties will share resources for the development of improved new drugs, leveraging complementary strengths to jointly advance research, clinical trials, market registration, and sales efforts. ScinoPharm Taiwan plans to acquire 22,000 shares in Handa's private placement, resulting in a 13.5 percent stake and becoming the second-largest shareholder. More... (in Chinese) |
| MegaPro Biomedical's MRI contrast agent new drug enrolls first domestic patient 19 December, 2024 MegaPro Biomedical (TW: 6827) announced that its independently developed MRI contrast agent new drug, MPB-2043, designed for lymph node staging in head and neck squamous cell carcinoma patients, has enrolled its first domestic patient at National Taiwan University Hospital. The drug is currently undergoing an Investigator-Initiated Trial (IIT), with clinical enrollment expected to be completed by the end of next year. More... (in Chinese) |
| ========================================= |
| 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 Email: daisy@taiwanbio.org.tw BIO Asia-Taiwan 2025 (23-27 July, 2025) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |