Monday, October 30, 2023 9:09:11 PM
10/30/2023 8:20 PM EST
Strategic partnerships create a promising future in neurological and mental health treatments
ABVC Biopharma Inc (ABVC) has recently gained interest in the investment community. The stock surged by 300% and then retreated on Thursday October 26, 2023 following the company's announcement of a term sheet to license global rights for CNS drugs targeting MDD and ADHD to AiBtl BioPharma for a valuation of $667 million. ABVC is excited about its major depressive disorder (MDD) and adult attention-deficit/hyperactivity disorder (ADHD) trials, which, if successful, will take the company closer to Phase III trials for those products and drive the multi-product biopharma company forward. ABVC has definitive agreements for the same CNS drugs with Xinnovation for ABV-1504, ABV-1505, and ABV-1601. The licensing deal carries a possible aggregate income of $20 million for ABVC. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032. Xinnovation will fund the Phase III trials under the agreement and ABVC gets the global market less the Chinese market.
ABVC's CNS drugs have been developed into a controlled-release tablet formulation or PDC-1421, the primary active ingredient in its neurological programs. This formulation enables the active ingredient to be absorbed slower over time compared to conventional tablet formulations, thereby reducing the dosage frequency and increasing the bioavailability.
The product is ready for an End-of-Phase II meeting with the FDA to finalize the protocol for Phase III trials. At the same time, ABVC commenced the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and another five sites in Taiwan. The trials are heading for the interim report, which ABVC expects to complete by the end of 2023.
Vitargus®: A groundbreaking hydrogel product for retinal detachment surgery
In ophthalmology, ABVC’s Vitargus® (ABV-1701) is a groundbreaking, advanced-staged flagship product that is expected to be the first biodegradable hydrogel product used in retinal detachment surgery. Vitargus® has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods Administration (TGA) to initiate the next phase of the trial in two participating sites. The Science Park Administration in Taiwan approved ABVC’s plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus® and to pursue the process development work for manufacturing optimization. This project is proposed by ABVC’s Taiwan affiliate and co-development partner, BioFirst Corporation. The Phase II trial of Vitargus is expected to release its results in Q4 2023. If the results are positive, it could lead to distribution agreements in Asia and Australia in early 2024. According to iHealthcare Analyst, Inc., the global market for retinal surgery devices is expected to reach $4.3 billion by 2029, driven, in part, by the rising geriatric population worldwide.
FDA approves clinical trial of BLEX 404 for advanced non-small cell lung cancer
The US FDA has approved the Investigational New Drug (IND) application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519. This treatment is being co-developed by BioKey, Inc. and by the Rgene Corporation, Taiwan. The study is under review at the Taiwan FDA for approval. With three previous INDs approved by the US FDA for combination therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer, BLEX 404 is a promising new option in the fight against cancer.
Here's a link for more information: LINK
In conclusion
ABVC Biopharma Inc. is a promising investment with multiple near-term catalysts. The company’s strategic partnerships in neurological and mental health treatments create a promising future. ABVC’s CNS drugs targeting MDD and ADHD have definitive agreements with Xinnovation for ABV-1504, ABV-1505 and ABV-1601, Thedefinitive agreement carries a possible aggregate income of $20 million for ABVC. There is also a licensing deal with AiBtl BioPharma for a valuation of $667 million. As per the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032. ABVC’s CNS has been developed into a controlled-release tablet formulation or PDC-1421, the primary active ingredient in its neurological programs. This formulation enables the active ingredient to be absorbed slower over time compared to conventional tablet formulations, thereby reducing the dosage frequency and increasing the bioavailability.
Investors should keep an eye on ABVC’s major depressive disorder (MDD) and adult attention-deficit/hyperactivity disorder (ADHD) trials, which, if successful, will take the company closer to Phase III trials for those products and drive its multi-product biopharma company forward. The product is ready for an End-of-Phase II meeting with the FDA to finalize the protocol for Phase III trials. At the same time, ABVC has commenced ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and another five sites in Taiwan. With all these developments in place, ABVC Biopharma Inc. is poised to make a significant impact in the biopharmaceutical industry
Recent ABVC News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 12:00:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 09:00:15 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/23/2024 08:30:39 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/22/2024 09:00:20 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/22/2024 06:31:18 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/17/2024 09:00:47 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/17/2024 08:01:51 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 01:00:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 01:27:45 PM
- AiBtl BioPharma Inc. Acquired TT Life Company, Valued at $8.33M, With 1.66M AiBtl Shares at $5 per Share • GlobeNewswire Inc. • 04/18/2024 01:25:00 PM
- ABVC BioPharma Executes a Global Licensing Definitive Agreement for the Treatment of NSCLC, Expecting Aggregate Income of $13.75M and Royalties of up to $12.50M • GlobeNewswire Inc. • 04/17/2024 01:00:00 PM
- ABVC BioPharma Executes a Global Licensing Term Sheet for Oncology/Hematology Products, Expecting Licensing Income of $55M and Royalties of up to $50M • GlobeNewswire Inc. • 04/10/2024 12:30:00 PM
- ABVC BioPharma Entered into a Global Licensing Deal of Vitargus with Licensing Income of $33.5M and Royalties up to $60M • GlobeNewswire Inc. • 03/26/2024 12:30:00 PM
- AiBtl BioPharma Inc. Completes $7.6M Land Deal: Exchanging Stock for Real Estate, Demonstrating the Value of ABVC's 23M AiBtl Share Ownership as Hundred Million Dollars • GlobeNewswire Inc. • 03/21/2024 12:30:00 PM
- ABVC BioPharma, Inc. CEO Selected as 2024 Top 10 CEO in CEO Insights Asia Magazine • GlobeNewswire Inc. • 03/19/2024 12:30:00 PM
- ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update • GlobeNewswire Inc. • 03/14/2024 01:30:31 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 02/29/2024 09:32:35 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 02/29/2024 09:31:06 PM
- ABVC's New Horizon for Oncology and Hematology Aims at Cancer Market of Several Hundred Billion Dollars • GlobeNewswire Inc. • 02/27/2024 01:30:00 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/16/2024 10:04:42 PM
- ABVC BioPharma Executes a Definitive Agreement to Receive License Fees of $3M and Royalties of 2% on Future Revenues • GlobeNewswire Inc. • 02/15/2024 01:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 12:59:14 AM
- ABVC BioPharma Receives Australian Patent, Valid Until 2040, for Its Treatment of Major Depressive Disorder (MDD) • GlobeNewswire Inc. • 02/12/2024 01:30:00 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/09/2024 10:04:50 PM
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