Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.</li>
<li>Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.</li>
<li>Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  </li>
</ul>


Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.
Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.
Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  


APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

<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>WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.</li>
<li>Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.</li>
<li>Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.</li>
</ul>


WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.
Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.
Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.


APAC Healthcare Weekly (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

<ul>
<li>Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.</li>
<li>Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.</li>
<li>Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.</li>
</ul>


Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.
Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.
Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.


APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

China

ImmuneOnco Biopharmaceuticals (Shanghai) (IOB HK)

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ImmuneOnco Biopharmaceuticals (Shanghai) (IOB HK)

APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

Kelun Bio announces Phase 3 trial success for ADC-Keytruda combo in first-line lung cancer. Otsuka got FDA approval for IgAN drug. Alteogen secures...

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 (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

Wuxi Bio got EMA nod for Ireland manufacturing facility. Daiichi Sankyo got breakthrough therapy designation for its drug candidate in US. CSL...

Tina Banerjee

APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Celltrion is acquiring a biopharmaceutical production plant in US. Wuxi Bio starts construction of new facility. CSPC and Jiangsu Hengrui stuck...

Tina Banerjee

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