Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.</li>
<li>Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.</li>
<li>SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.</li>
</ul>


Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.
Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.
SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.


APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

<ul>
<li>Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.</li>
<li>FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. </li>
<li>Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.</li>
</ul>


Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.
FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. 
Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.


APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

<ul>
<li>Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.</li>
<li>WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.</li>
<li>Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.</li>
</ul>


Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.
WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.
Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.


APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

<ul>
<li>Samsung Biologics launches organoid-based drug screening services to support early-stage drug discovery and development. Daewoong Pharmaceutical signed a five-year KRW74B export agreement for botulinum toxin product with its Thailand partner.</li>
<li>Shionogi’s tender offer for Torii Pharmaceutical has become successful. Simcere stuck outlicensing agreement with NextCure for ADC drug candidate SIM0505 for upfront payment, development, and sales milestones up to $745M.</li>
<li>CSL received FDA approval of Andemry for hereditary angioedema. PharmaEssentia has received marketing approval of Besremi in Argentina. Lotus Pharmaceutical acquires a portfolio of five drugs in Vietnam.</li>
</ul>


Samsung Biologics launches organoid-based drug screening services to support early-stage drug discovery and development. Daewoong Pharmaceutical signed a five-year KRW74B export agreement for botulinum toxin product with its Thailand partner.
Shionogi’s tender offer for Torii Pharmaceutical has become successful. Simcere stuck outlicensing agreement with NextCure for ADC drug candidate SIM0505 for upfront payment, development, and sales milestones up to $745M.
CSL received FDA approval of Andemry for hereditary angioedema. PharmaEssentia has received marketing approval of Besremi in Argentina. Lotus Pharmaceutical acquires a portfolio of five drugs in Vietnam.


APAC Healthcare Weekly (June 22)- Samsung Biologics, Daewoong Pharma, Shionogi, Simcere, CSL

<ul>
<li>Eisai received approval for its insomnia drug, Dayvigo in China. Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.</li>
<li>Samsung Biologics secured two CMO contract worth KRW441B from unnamed pharmaceutical companies in Asia and Europe. SK Bioscience has completed a major expansion of its vaccine production facility in Andong.</li>
<li>CSPC Pharmaceutical is in negotiations regarding three potential outlicensing deals. Jiangsu Hengrui Pharmaceuticals received approvals for three drugs in China. Hansoh’s third BLA for Xinyue has been accepted by NMPA.</li>
</ul>


Eisai received approval for its insomnia drug, Dayvigo in China. Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.
Samsung Biologics secured two CMO contract worth KRW441B from unnamed pharmaceutical companies in Asia and Europe. SK Bioscience has completed a major expansion of its vaccine production facility in Andong.
CSPC Pharmaceutical is in negotiations regarding three potential outlicensing deals. Jiangsu Hengrui Pharmaceuticals received approvals for three drugs in China. Hansoh’s third BLA for Xinyue has been accepted by NMPA.


APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

Japan

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

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Shionogi & Co (4507 JP)

APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

Tina Banerjee

APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

Simcere, CSPC, and Sino Bio got approvals for their new drugs in China. Apollo Hospital announced a demerger. Torrent is acquiring controlling...

Tina Banerjee

APAC Healthcare Weekly (June 22)- Samsung Biologics, Daewoong Pharma, Shionogi, Simcere, CSL

Samsung Bio launches new service for early-stage biotechs. Shionogi’s tender offer for Torii becomes successful. Simcere stuck outlicensing deal....

Tina Banerjee

APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...

Tina Banerjee

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APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

Tina Banerjee

APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

Simcere, CSPC, and Sino Bio got approvals for their new drugs in China. Apollo Hospital announced a demerger. Torrent is acquiring controlling...

Tina Banerjee

APAC Healthcare Weekly (June 22)- Samsung Biologics, Daewoong Pharma, Shionogi, Simcere, CSL

Samsung Bio launches new service for early-stage biotechs. Shionogi’s tender offer for Torii becomes successful. Simcere stuck outlicensing deal....

Tina Banerjee

APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

​Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...

Tina Banerjee

Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...