Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/oneness-biotech-co-ltd" target="_blank" data-smartkarma-citation="entities:6357:1" rel="noopener">Oneness Biotech (4743 TT)</a> entered into an exclusive agreement with <a href="https://www.smartkarma.com/entities/china-resources-dubl-crne-phrmctl-co-ltd" target="_blank" data-smartkarma-citation="entities:16578:1" rel="noopener">China Resources Dubl Crne Phrmctl (600062 CH)</a> for commercialization of Fespixon in China, Hong Kong, and Macau.</li>
<li>Fespixon is approved in China as the first new drug for diabetic foot ulcer. Inclusion of the drug in NRDL is the next important milestone.</li>
<li>During 1H24, Oneness Biotech reported revenue of NT$57M, up 36% YoY. With expanding scale of operation, gross profit margin is improving (1Q24: 62.5% vs. 1Q23: 47.9%). Net loss is decreasing.</li>
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Oneness Biotech (4743 TT) entered into an exclusive agreement with China Resources Dubl Crne Phrmctl (600062 CH) for commercialization of Fespixon in China, Hong Kong, and Macau.
Fespixon is approved in China as the first new drug for diabetic foot ulcer. Inclusion of the drug in NRDL is the next important milestone.
During 1H24, Oneness Biotech reported revenue of NT$57M, up 36% YoY. With expanding scale of operation, gross profit margin is improving (1Q24: 62.5% vs. 1Q23: 47.9%). Net loss is decreasing.


Oneness Biotech (4743 TT): Marketing Progress of Fespixon in China Opens a New Revenue Stream

Thematic (Sector/Industry)

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<li>Alteogen has signed an exclusive license agreement with Daiichi Sankyo to develop and commercialize a subcutaneous version of Enhertu. Volpara won $7.3M contract from the U.S. Defense Health Agency.</li>
<li>Santen Pharmaceutical has rolled out Rhopressa ophthalmic solution in South Korea for the treatment of open-angle glaucoma or ocular hypertension.</li>
<li>Sun Pharmaceutical’s launch of alopecia drug Leqselvi in the U.S. will be delayed due to litigation with Incyte. Recently, a U.S. District Court decided to grant a preliminary injunction.</li>
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Alteogen has signed an exclusive license agreement with Daiichi Sankyo to develop and commercialize a subcutaneous version of Enhertu. Volpara won $7.3M contract from the U.S. Defense Health Agency.
Santen Pharmaceutical has rolled out Rhopressa ophthalmic solution in South Korea for the treatment of open-angle glaucoma or ocular hypertension.
Sun Pharmaceutical’s launch of alopecia drug Leqselvi in the U.S. will be delayed due to litigation with Incyte. Recently, a U.S. District Court decided to grant a preliminary injunction.


APAC Healthcare Weekly (Nov 10)- Alteogen, Santen Pharmaceutical, Beigene, Sun Pharmaceutical

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<a href="https://www.smartkarma.com/entities/oneness-biotech-co-ltd" target="_blank" data-smartkarma-citation="entities:6357:1" rel="noopener">Oneness Biotech (4743 TT)</a> recorded 10% revenue growth in Q1. However, operating loss widened. With global expansion of the marketed drug, the company is expected to turn profitable in 2024.</li>
<li>In January 2023, Oneness received marketing approval for Fespixon in Singapore, with launch expected in 2H23. Fespixon is also expected to receive approval in Philippines this year. </li>
<li>Oneness is conducting phase 3 trial for Fespixon in the U.S., with targeting NDA submission in 2026. Fespixon has an estimated addressable market opportunity of $14.8B for diabetic foot ulcer.</li>
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Oneness Biotech (4743 TT) recorded 10% revenue growth in Q1. However, operating loss widened. With global expansion of the marketed drug, the company is expected to turn profitable in 2024.
In January 2023, Oneness received marketing approval for Fespixon in Singapore, with launch expected in 2H23. Fespixon is also expected to receive approval in Philippines this year. 
Oneness is conducting phase 3 trial for Fespixon in the U.S., with targeting NDA submission in 2026. Fespixon has an estimated addressable market opportunity of $14.8B for diabetic foot ulcer.


Oneness Biotech (4743 TT): Global Expansion of Marketed Product & Pipeline Progress

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<a href="https://www.smartkarma.com/entities/oneness-biotech-co-ltd" target="_blank" data-smartkarma-citation="entities:6357:1" rel="noopener">Oneness Biotech (4743 TT)</a> is showing steady progress in its R&amp;D pipeline. The company submitted IND application to FDA for phase 1 trial of SNS812 for the treatment of COVID-19.</li>
<li>SNS812 is a first-in-class broad-spectrum siRNA-based new drug against SARS-CoV-2 variants covering 99.8% of current variants and shown picomolar inhibition of dominant ones, including Alpha, Delta, Gamma, Epsilon, and Omicron.</li>
<li>The health authorities in Singapore, Malaysia, the Philippines, and Vietnam have accepted the NDA application of Fespixon, which has been commercialized in Taiwan last year for diabetes foot ulcer.</li>
</ul>



Oneness Biotech (4743 TT) is showing steady progress in its R&amp;D pipeline. The company submitted IND application to FDA for phase 1 trial of SNS812 for the treatment of COVID-19.
SNS812 is a first-in-class broad-spectrum siRNA-based new drug against SARS-CoV-2 variants covering 99.8% of current variants and shown picomolar inhibition of dominant ones, including Alpha, Delta, Gamma, Epsilon, and Omicron.
The health authorities in Singapore, Malaysia, the Philippines, and Vietnam have accepted the NDA application of Fespixon, which has been commercialized in Taiwan last year for diabetes foot ulcer.


Oneness Biotech (4743 TT): Positive Clinical Trial Progress Is Pushing Stock Prices to Higher Highs

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<a href="https://www.smartkarma.com/entities/oneness-biotech-co-ltd" target="_blank" data-smartkarma-citation="entities:6357:1" rel="noopener">Oneness Biotech (4743 TT)'s</a> approved drug in Taiwan, Fespixon is the world’s first drug to treat diabetic foot ulcers with superiority in complete wound closure to the standard of care.</li>
<li>Fespixon is under review in China, and is under multiple NDA submissions to Asian health authorities. The U.S. phase 3 study is expected to be completed in H1 2023.</li>
<li>Key milestones are expected from two other late-stage pipeline drug candidates, FB825 and FB704A in 2022 and beyond.    </li>
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Oneness Biotech (4743 TT)'s approved drug in Taiwan, Fespixon is the world’s first drug to treat diabetic foot ulcers with superiority in complete wound closure to the standard of care.
Fespixon is under review in China, and is under multiple NDA submissions to Asian health authorities. The U.S. phase 3 study is expected to be completed in H1 2023.
Key milestones are expected from two other late-stage pipeline drug candidates, FB825 and FB704A in 2022 and beyond.    


Oneness Biotech (4743 TT): Worth of Attention Ahead of Upcoming Key Milestones

Taiwan

Oneness Biotech Co Ltd develops botanical new drugs and several biological-active new chemical entities that are purified and molecularly modified from these botanical sources.

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Oneness Biotech (4743 TT)