ABVC BioPharma Inc (ABVC)

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ABVC BioPharma: A Promising Investment With Multiple Near-Term Catalysts

10/31/2023 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 its multi-product biopharma company forward. Investors should remember that 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 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.

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, we 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 we expect 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.

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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.