Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Fosun Pharmaceutical’s marketing application of acute lymphoblastic leukemia drug was accepted by the NMPA. CSPC Pharma obtained approval to conduct clinical trial for Leqembi biosimilar in China.</li>
<li>Celltrion is acquiring Eli Lilly’s New Jersey biopharmaceutical production plant for KRW460B. Lotus Pharmaceutical is acquiring Alvogen US, a privately held, fully integrated pharmaceutical company.</li>
<li>Glenmark Pharmaceutical entered into an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan, a next-generation HER2-targeting antibody drug conjugate (ADC) for an upfront payment of $18M.</li>
</ul>


Fosun Pharmaceutical’s marketing application of acute lymphoblastic leukemia drug was accepted by the NMPA. CSPC Pharma obtained approval to conduct clinical trial for Leqembi biosimilar in China.
Celltrion is acquiring Eli Lilly’s New Jersey biopharmaceutical production plant for KRW460B. Lotus Pharmaceutical is acquiring Alvogen US, a privately held, fully integrated pharmaceutical company.
Glenmark Pharmaceutical entered into an exclusive license and collaboration agreement with Hengrui Pharma for Trastuzumab Rezetecan, a next-generation HER2-targeting antibody drug conjugate (ADC) for an upfront payment of $18M.


APAC Healthcare Weekly (September 28) – Fosun Pharma, CSPC Pharma, Celltrion, Lotus Pharma, Glenmark

<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>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>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>Fosun Pharma outlicensed XH-S004 to Expedition Therapeutics for $120M upfront and milestone payment. Remegen’s drug candidate met primary endpoint in Phase 3 trial for Sjögren's syndrome in China.</li>
<li>Astellas Pharma announced positive topline results from the Phase 3 trial evaluating Padcev in bladder cancer. Daewoong Pharmaceutical announced positive result for their self-developed semaglutide microneedle patch.</li>
<li>Zydus Lifesciences received FDA approval for chest pain drug Diltiazem Hydrochloride tablets. Lupin has partnered with Sandoz to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.</li>
</ul>


Fosun Pharma outlicensed XH-S004 to Expedition Therapeutics for $120M upfront and milestone payment. Remegen’s drug candidate met primary endpoint in Phase 3 trial for Sjögren's syndrome in China.
Astellas Pharma announced positive topline results from the Phase 3 trial evaluating Padcev in bladder cancer. Daewoong Pharmaceutical announced positive result for their self-developed semaglutide microneedle patch.
Zydus Lifesciences received FDA approval for chest pain drug Diltiazem Hydrochloride tablets. Lupin has partnered with Sandoz to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.


APAC Healthcare Weekly (Aug 17) – Fosun Pharma, Remegen, Astellas, Daewoong Pharma, Zydus, Lupin

India

Lupin is an Indian multinational pharmaceutical company that develops, manufactures, and markets a diverse range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs). The company specializes in therapeutic areas such as cardiovascular, anti-diabetic, respiratory, anti-infective, and women's health. Lupin Limited was founded in 1968 and is headquartered in Mumbai, India.

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Lupin (LPC IN)

APAC Healthcare Weekly (September 28) – Fosun Pharma, CSPC Pharma, Celltrion, Lotus Pharma, Glenmark

CSPC Pharma got trial approval for Leqembi biosimilar. Celltrion is acquiring Lilly’s plant. Lotus Pharmaceutical is acquiring Alvogen US. Hengrui...

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 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 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 17) – Fosun Pharma, Remegen, Astellas, Daewoong Pharma, Zydus, Lupin

Astellas, Remegen, and Daewoong Pharma announced positive trial results for their respective drug candidates. Fosun Pharma stuck outlicensing deal....

Tina Banerjee

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