Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.</li>
<li>Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  </li>
<li>The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.</li>
</ul>


Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.
Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  
The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.


APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

<ul>
<li>Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.</li>
<li>Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.</li>
<li>CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.</li>
</ul>


Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.
Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.
CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.


APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

<ul>
<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>
</ul>


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

Equity Bottom-Up

<ul>
<li>
<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>
</ul>



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

<ul>
<li>
<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>
</ul>



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

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)

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

Tina Banerjee

APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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

Alteogen partners with Daiichi Sankyo for Enhertu, Volpara secures $7.3M contract, Santen launches Rhopressa in South Korea, Sun Pharma's Leqselvi...

Tina Banerjee