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>Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.</li>
<li>Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.</li>
<li>Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.</li>
</ul>


Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.
Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.
Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.


APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

<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

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

Japan

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

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Nippon Shinyaku (4516 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 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

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

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

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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