Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.</li>
<li>Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.</li>
<li>Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.</li>
</ul>


CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.
Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.
Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.


APAC Healthcare Weekly (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

<ul>
<li>Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.</li>
<li>EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.</li>
<li>ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.</li>
</ul>


Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.
EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.
ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.


APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

<ul>
<li>ImmuneOnco received clinical trial approval of timdarpacept for the treatment of atherosclerosis in China. Wuxi Biologics’ two facilities received GMP certifications from UK MHRA for commercial manufacturing of ophthalmic biologic. </li>
<li>Eisai signed an exclusive license and collaboration agreement with Nuvation Bio for NSCLC drug taletrectinib. Daiichi Sankyo initiates phase 3 trial evaluating Datroway in NSCLC.</li>
<li>SK Biopharmaceutical secured FDA nod to conduct Phase 1 clinical trial of its radiopharmaceutical therapy candidate SKL35501. HK inno.N submitted NDA for its GERD drug K-Cab to the FDA.</li>
</ul>


ImmuneOnco received clinical trial approval of timdarpacept for the treatment of atherosclerosis in China. Wuxi Biologics’ two facilities received GMP certifications from UK MHRA for commercial manufacturing of ophthalmic biologic. 
Eisai signed an exclusive license and collaboration agreement with Nuvation Bio for NSCLC drug taletrectinib. Daiichi Sankyo initiates phase 3 trial evaluating Datroway in NSCLC.
SK Biopharmaceutical secured FDA nod to conduct Phase 1 clinical trial of its radiopharmaceutical therapy candidate SKL35501. HK inno.N submitted NDA for its GERD drug K-Cab to the FDA.


APAC Healthcare Weekly (January 18) – ImmuneOnco, Wuxi Bio, Eisai, Daiichi, SK Biopharm, HK Inno.N

<ul>
<li>Jiangsu Hengrui received approval for its innovative drug Retlirafusp alfa Injection in China. Hansoh’s innovative drug Ameile got fifth indication expansion approval in China for NSCLC.</li>
<li>InSilico Medicine entered multi-year R&amp;D collaboration valued at $888M with Servier. Takeda Pharmaceutical filed NDA to the FDA seeking approval of rusfertide for the treatment of polycythemia vera.</li>
<li>Hanmi Pharmaceutical will distribute and sell Teva’s migraine preventive treatment Ajovy in Korea. Dr. Reddy’s Laboratories has launched Hevaxin vaccine for the prevention of Hepatitis E virus infection in India.</li>
</ul>


Jiangsu Hengrui received approval for its innovative drug Retlirafusp alfa Injection in China. Hansoh’s innovative drug Ameile got fifth indication expansion approval in China for NSCLC.
InSilico Medicine entered multi-year R&amp;D collaboration valued at $888M with Servier. Takeda Pharmaceutical filed NDA to the FDA seeking approval of rusfertide for the treatment of polycythemia vera.
Hanmi Pharmaceutical will distribute and sell Teva’s migraine preventive treatment Ajovy in Korea. Dr. Reddy’s Laboratories has launched Hevaxin vaccine for the prevention of Hepatitis E virus infection in India.


APAC Healthcare Weekly (January 11) – Hengrui, Hansoh, InSilico Medicine, Takeda, Hanmi Pharm

<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

India

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company that researches, develops, manufactures, and markets a wide array of pharmaceutical products and services. The company produces over 190 medications, 60 active pharmaceutical ingredients, diagnostic kits, critical care, and biotechnology products. It operates globally across multiple regions, offering generic drugs, active pharmaceutical ingredients (APIs), differentiated formulations, biosimilars, and proprietary products. The company was founded in 1984 and is headquartered in Hyderabad, Telangana, India.

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Dr. Reddy's Laboratories (DRRD IN)

APAC Healthcare Weekly (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

CStone’s sugemalimab got label expansion in UK. HBM Holdings entered exclusive license agreement with Solstice Oncology. Astellas Pharma and Vir...

Tina Banerjee

APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

Hansoh Pharma got EU approval for Ameile. EMA validated Daiichi Sankyo’s Enhertu in breast cancer. FDA accepted Ono Pharmaceutical’s tirabrutinib....

Tina Banerjee

APAC Healthcare Weekly (January 18) – ImmuneOnco, Wuxi Bio, Eisai, Daiichi, SK Biopharm, HK Inno.N

ImmuneOnco got trial approval for atherosclerosis drug candidate, timdarpacept in China. Eisai secures rights to NSCLC drug taletrectinib. HK inno...

Tina Banerjee

APAC Healthcare Weekly (January 11) – Hengrui, Hansoh, InSilico Medicine, Takeda, Hanmi Pharm

Hegrui got nod for new drug and Hansoh’s Ameile secured additional indication in China. InSilico entered $888M R&D collaboration. Takeda filed for...

Tina Banerjee

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

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