Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.</li>
<li>Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.</li>
<li>Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.</li>
</ul>


SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.
Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.
Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.


APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

<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>Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.</li>
<li>Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.</li>
<li>Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.</li>
</ul>


Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.
Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.
Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.


APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

<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>Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.</li>
<li>CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.</li>
<li>LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.</li>
</ul>


Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.
CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.
LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.


APAC Healthcare Weekly (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

Japan

ONO PHARMACEUTICAL CO., LTD. manufactures and sells pharmaceuticals.  The Company mainly researches and develops prescription drugs.

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Ono Pharmaceutical (4528 JP)

APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

SillaJen got FDA nod for clinical trial indication expansion. FDA approves Akeso’s first drug. Innovent’s cancer drug was approved in China....

Tina Banerjee

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 (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

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 (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 (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

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

Tina Banerjee

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