Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.</li>
<li>Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.</li>
<li>HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.</li>
</ul>


Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.
Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.
HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.


APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

<ul>
<li>Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.</li>
<li>Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. </li>
<li>Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.</li>
</ul>


Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.
Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. 
Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.


APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

<ul>
<li>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

<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

Japan

JCR Pharmaceuticals Co., Ltd. develops, produces, and sells pharmaceutical products and raw materials.  The Company also sells equipment for hospital and laboratory use.  JCR Pharmaceuticals' products include drug for leukemic diseases and hormonal agents including genetically engineered human somatotrophic hormone (growth hormone) and gonadotropic hormone.

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Jcr Pharmaceuticals (4552 JP)

APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

InSilico entered outlicensing deal. Daiichi’s Enhertu got China approval for 6th indication. Shionogi will pick up Pfizer’s stake in ViiV...

Tina Banerjee

APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

Innovent Biologics announced collaboration with Takeda. FDA approves two additional indications for Celltrion's Humira biosimilar. Syngene is...

Tina Banerjee

APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

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

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