8/19 Taiwan Life Sciences Biweekly Newsletter
2024-08-19 |
| Taiwan Life Sciences Biweekly |
| Intech Biopharm partners with North American company to capture slice of global inhaler market 13 August, 2024 Intech Biopharm (TW: 6461) announced that it had signed an agreement with an unnamed North American company to co-develop its nasal spray product SYN021. The two companies plan to launch two to three nasal spray products in the future, targeting the massive global inhaler market. According to the announcement, Intech Biopharm is the only company in Taiwan and one of the few globally with the capability to develop and manufacture inhalers. To cater to the rapid growth in the nasal spray market, Intech has completed its nasal spray product line, with an annual production capacity of tens of millions of doses. With the addition of nasal sprays, Intech Biopharm’s product line now covers metered-dose inhalers (MDIs) for the lower respiratory tract, and nasal sprays for the upper respiratory tract. In December, Intech Biopharm entered the Canadian market with its compound lower respiratory inhaler SYN011. With Canada's annual demand at around 10 million inhaler units, market size is estimated to be NT$1.2 billion. More... (in Chinese) |
| HCmed Innovations completes US rare disease R&D project 13 August, 2024 HCmed Innovations (TW: 6934) announced the successful completion of a drug-device combination product development project together with an unnamed US-based company specializing in rare diseases. The project utilized HCmed's second-generation smart nebulizer, AdheRespR, with its new vibrating mesh nebulizer equipped with a breathing detection function. Due to the timely completion of the collaboration, HCmed received 50 percent of the total contract payment. With the receipt of this 50 percent payment, HCmed's revenue for the first seven months of this year reached NT$32 million, an annual growth rate of 1128 percent. More... (in Chinese) |
| Medigen Vaccine Biologics announces major increase in shipment of enterovirus vaccine, will turn profitable in Q2 13 August, 2024 Medigen Vaccine Biologics Corporation (MVC) (TW: 6547) announced that in Q2 the company saw a significant increase in the shipment of its enterovirus vaccine, leading to a 199 percent increase in quarterly revenue and a return to profitability. The company reported earnings per share (EPS) of NT$0.04. With the enterovirus vaccine on the market for only a year, all 220,000 doses produced were sold out, contributing NT$550 million to revenue. As local awareness of the importance of vaccination against enterovirus grows, MVC predicts that the penetration rate in Taiwan will double from the current 10 percent within three years. Additionally, the company is hopeful of securing approval in Vietnam by the end of this year or early next year. More... (in Chinese) |
| TRACT Transfers Its Regulatory T Cell Platform Technology to Taiwan Bio’s Manufacturing Facility 12 August, 2024 Taiwan Bio Therapeutics and TRACT Therapeutics report the successful transfer of Tract Therapeutics’ regulatory T cell (TregCelTM) platform technology to Taiwan Bio’s GMP cell manufacturing facility. Tract Company officials call the move a critical milestone and a significant step forward as the companies prepare for the initiation of a global Phase II clinical trial in living donor kidney transplant patients. They also view it as an exciting development for solid organ transplant patients seeking new therapeutic options to improve their quality of life. More... |
| Foresee Pharmaceuticals announces launch of four new drug delivery systems 12 August, 2024 Foresee Pharmaceuticals (TW: 6576) announced the launch of four novel and proprietary Stabilized Injectable Formulation-Long-Acting Injectable (SIF-LAI) drug delivery systems: SIF-ADAGIOTM, SIF-LEGATOTM, SIF-DUOTM, and SIF-MEZZOTM. The company also summarized its recent advances in SIF technology and its current leadership in this field. More... (in Chinese) |
| Pharmosa Biopharm licensing partner Liquidia plans for global Phase III trial for L606 9 August, 2024 Pharmosa Biopharm (TW: 6875) announced that it received notification from its North American licensing partner, Liquidia Technologies regarding a global Phase III clinical trial planned for its new drug L606, aimed at treating pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia has completed consultations with the European Medicines Agency (EMA) on the design of the Phase III trial. Based on feedback from both the US FDA and the European EMA, Liquidia will finalize the clinical trial design and plans to initiate the global Phase III trial for PH-ILD later this year. Currently, the only available treatment in North America is Tyvaso/Tyvaso DPI, which requires an inhalation regimen every four hours or four times a day. Pharmosa plans to launch L606 globally, aiming not only to provide North American patients with a better treatment option but also to introduce the first available treatment for PH-ILD patients in countries where no such therapies currently exist. Pharmosa intends to use the feedback received from both the European EMA and the FDA to assist it in negotiating licensing deals for the drug in markets outside of North America, including Europe, Japan, and the Middle East. More... (in Chinese) |
| Taiwan stages Asia-Pacific health promotion workshop 9 August, 2024 The 2024 Asia Pacific Health Promotion and Non-Communicable Disease Prevention Workshop was held Aug. 6-7 at the National Health Research Institutes in Miaoli County, northern Taiwan, bringing regional academics, experts and officials together to exchange views on key health issues and explore ways to expand multilateral cooperation. More... |
| TWi Biotechnology's announces financial results, plans clinical trials for AC-203 in various countries 9 August, 2024 TWi Biotechnology, Inc. (TW: 6610) announced that its board of directors has approved the financial report for the first half of the year. Due to its new drugs still being in the development and clinical stages, the company reported a loss of NT$1.1 per share for the period. TWi Biotechnology stated that it will continue to advance the development of its two candidate drugs, AC-203 and AC-1101. The late-stage new drug AC-203, in the form of a topical ointment, is currently undergoing global multi-center Phase II/III clinical trials for the treatment of simplex epidermolysis bullosa (EBS). It has received approval to start recruitment in 12 countries, including the United States, Taiwan, Australia, the Philippines, the United Kingdom, Italy, Austria, Poland, Malaysia, Israel, South Korea, and France. More... (in Chinese) |
| China Medical University Hsinchu Hospital: First in Taiwan to integrate AI in spinal surgery 8 August, 2024 China Medical University Hsinchu Hospital has integrated its departments of neurosurgery, orthopedics, rehabilitation, and traditional Chinese medicine to provide comprehensive pain management for spinal disorders. On the 7th, the hospital established the AI Minimally Invasive Spine Center, utilizing computer navigation equipment developed by a biomedical park vendor combined with AI for precise medical care, the first in the country to use AI navigation devices for spinal surgeries, according to the hospital, significantly reducing time and minimizing the exposure of both doctors and patients to X-ray radiation. More... (in Chinese) |
| OBI Pharma's new drug OBI-992 receives FDA Orphan Drug Designation for gastric cancer 8 August, 2024 OBI Pharma (TW: 4174) announced that its new antibody-drug conjugate (ADC) drug, OBI-992, had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of gastric cancer. OBI-992 targets TROP2, a protein highly expressed in various solid tumors, including gastric cancer and other cancer types such as lung, breast, and ovarian cancer. In June, OBI-992 began Phase I/II clinical trials in the US on patients with advanced solid tumors to evaluate safety, pharmacokinetics, and preliminary efficacy. OBI Pharma acquired the rights to the TROP2 antibody from Biosion in December 2021, and has since been responsible for the ADC's development and construction, with commercial rights outside of China. More... (in Chinese) |
| Formosa Pharma and Eyenovia Announce Initiation of Co-Development of Clobetasol Propionate Ophthalmic Suspension, 0.05%, for the treatment of Acute Dry Eye Disease in United States Press release 7 August, 2024 Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has signed a non-binding terms agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN), whereby the companies will co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% ("clobetasol propionate") for the short-term relief of dry eye disease. Both companies will conduct due diligence and work toward a definitive agreement that will include the sharing of development costs and the division of profit upon commercialization. This agreement will effectively expand Eyenovia and Formosa's existing collaboration agreement signed in February 2023 which included the testing of clobetasol propionate in the Optejet® and a consultation meeting with the FDA to discuss the dry eye indications. More... |
| Taichung Veterans General Hospital and Boehringer Ingelheim sign clinical trial MOU 7 August, 2024 Taichung Veterans General Hospital and Boehringer Ingelheim signed a clinical trial cooperation memorandum of understanding (MOU) yesterday. Taichung Veterans General Hospital's Director, Chen Shih-Ann stated that the hospital focuses on patient-centered care and in addition to introducing advanced medical equipment and technology, it is also committed to developing emerging treatments and research in challenging fields such as acute, severe, rare, and difficult medical conditions, aligning with Boehringer Ingelheim’s development goals. Boehringer Ingelheim Taiwan General Manager James Chiou noted that the clinical trial collaboration with Taichung Veterans General Hospital will cover early-phase clinical trials across various disease areas including pulmonary fibrosis, cancer, and autoimmune diseases. By integrating the strengths and resources of both parties, the collaboration aims to accelerate the international early clinical trial process and enhance Taiwan’s influence in new drug development. Future focus will be on six major specialties: pulmonology—progressive fibrotic interstitial lung disease, diabetes-related kidney disease, oncology, schizophrenia, immunology, and ophthalmology. More... (in Chinese) |
| Bora Pharmaceuticals gains operational momentum with USL generic drug listing in the US 7 August, 2024 Bora Pharmaceuticals (TW: 6472) announced that USL, the US sales platform that joined the group in April this year, has successfully listed its third branded generic drug, TORPENZ (everolimus) tablets, in the US, meeting its projected timeline. This move demonstrates USL's continued strengthening of its product portfolio and showcases Bora's efficiency in post-merger business integration. More... (in Chinese) |
| Oneness Biotech's Fespixon passes registration review with Indonesian food and drug authority 6 August, 2024 Oneness Biotech (TW: 4743) announced that its new drug for diabetic foot ulcers, Fespixon, had passed the registration review by the Indonesian Food and Drug Authority (BPOM). This development opens up a significant market opportunity for treating approximately 2 million diabetic foot ulcer patients in that country. Oneness Biotech noted that Fespixon is the world's only innovative drug specifically targeting the etiology of diabetic foot ulcers. Clinical trials and post-market studies have confirmed its effectiveness in rapidly promoting wound healing for various difficult-to-heal ulcers, with notable pharmacoeconomic advantages. More... (in Chinese) |
| NHRI team unveils possible targeted therapy cancer drug 6 August, 2024 A team at the National Health Research Institutes (NHRI) has discovered a novel orally available small molecule, DBPR728, that can cut off the nutrient supply for cancer cell growth, which can serve as a new targeted therapy drug. The research team consists of scientists from the NHRI’s Institute of Biotechnology and Pharmaceutical Research, including Chi Ya-hui, Yeh Teng-kuang, Chen Chiung-tong and Chang Chun-ping. More... |
| General Biologicals accelerating new product development 6 August, 2024 As noted in this news profile on General Biologicals (TW: 4117) the company has been focused on precision medicine, expanding into biopharmaceuticals and personal healthcare. Collaborating with partners, the company is building a Chemiluminescence Immunoassay (CLIA) platform and developing 15 in vitro diagnostic reagents to support its automated GBC Chemiluminescence Analyzer systems. Seeing growing demand in precision diagnostics, liquid biopsy, and CDMO services, General Biologics is investing in molecular diagnostics and cancer detection technologies. Its CellBioTM circulating tumor cell (CTC) detection system, which aids in early cancer detection and treatment monitoring, has earned a national award and is integrated into services offered in partnership with Fubon Life Insurance, completing around 20,000 cases by 2023. More... (in Chinese) |
| TaiRx's oral anti-cancer drug combination therapy Phase II clinical trial results revealed at ASCO 6 August, 2024 TaiRx (TW: 6580) announced that its oral anticancer drug CVM-1118, in combination with the immune checkpoint inhibitor nivolumab (Opdivo), has completed the first phase enrollment for its Phase II clinical trial for advanced liver cancer. The results have met expected efficacy and demonstrated good safety, and were selected for presentation in poster form at the ASCO Breakthrough summit, organized by the American Society of Clinical Oncology. TaiRx plans to collaborate with major international pharmaceutical companies for larger-scale clinical trials. More... (in Chinese) |
| Formosa Pharmaceuticals Announces Licensing Agreement with Apotex Inc., for Commercialization of Clobetasol Propionate Ophthalmic Suspension for Ocular Surgery Relief and Recovery Press release 5 August, 2024 Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into an exclusive licensing agreement with Apotex Inc. ("Apotex"), for exclusive rights in Canada to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing deal will include certain payments, including an upfront payment and milestone payments upon achievement of certain regulatory and sales milestones. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). APP13007 will enter a ~$C50M market for topical ophthalmic steroids and steroid combinations, growing at around 5% annually, driven by an estimated ~500,000 ocular surgeries annually in Canada. More... |
| NDA Submitted for TaiGen Influenza Antiviral TG-1000 in Mainland China Press release 5 August, 2024 TaiGen Biotechnology Company, Limited (“TaiGen”) announces today that the business partner, Joincare Pharmaceutical, has submitted the New Drug Application (NDA) for the influenza antiviral Pixavir marboxil (TG-1000) to the National Medical Products Administration (NMPA) in mainland China. The NDA submission is supported by a phase III trial comparing Pixavir to placebo in 752 adult and adolescent patients with uncomplicated acute influenza infection. The primary endpoint of the study, the median time to alleviation of all influenza symptoms in the Pixavir group was 60.9 hours, compared to 87.9 hours in the placebo group, demonstrating a statistically significant reduction (P<0.0001). Subgroup analyses by virus subtype and age also showed significantly shorter symptom relief times compared to the placebo group, with an even greater difference in median relief time among adolescents, indicating that the drug is more effective for adolescent flu patients. More... |
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| 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 2024 (24-28 July, 2024) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |