Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.</li>
<li>Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.</li>
</ul>


Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.
Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.
Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.


APAC Healthcare Weekly (October 19) – Hansoh, Leads Biolabs, Chugai, SanBio, Celltrion, Samsung Bio

<ul>
<li>Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.</li>
<li>Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.</li>
<li>Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.</li>
</ul>


Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.
Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.
Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.


APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

<ul>
<li>CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.</li>
<li>Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.</li>
<li>Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.</li>
</ul>


CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.
Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.
Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.


APAC Healthcare Weekly (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

<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>Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.</li>
<li>WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.</li>
<li>Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.</li>
</ul>


Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.
WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.
Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.


APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

South Korea

HK inno.N Corp. develops and manufactures pharmaceuticals products. The Company develops and sells immune anticancer drugs, blood disease drugs, kidney disease drugs, and other products. HK inno.N conducts businesses across worldwide.

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HK inno.N (195940 KS)

APAC Healthcare Weekly (October 19) – Hansoh, Leads Biolabs, Chugai, SanBio, Celltrion, Samsung Bio

Hansoh and Leads Biolabs bag global outlicensing deals. Chugai’s partner Lilly announced positive P3 result for orforglipron. Celltrion launched...

Tina Banerjee

APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

Fosun Pharma and Astellas got new drug approvals. Chugai and SK Biopharma announced positive Phase 3 trial result. Alteogen’s technology powered...

Tina Banerjee

APAC Healthcare Weekly (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

CSPC Pharma’s NDA for Anbenitamab injection has been accepted in China. TransThera got trial approval for lead candidate. Samsung Bio signed $1.3B...

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 (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

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