Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.</li>
<li>Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.</li>
</ul>


Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.
Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.
Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.


APAC Healthcare Weekly (Aug 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

<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

<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

<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

South Korea

Daewoong Pharmaceutical Co., Ltd. develops various kinds of medical drugs and vitamin supplements.  The Company's medical drugs are used in areas, such as cardiology, dermatology, anti-biotic, and many other medical areas.  Dae Woong's over-the-counter products include smoking deterrents, vitamins, and minerals.

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Daewoong Pharmaceutical Co (069620 KS)

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (Aug 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

Terumo announced new acquisition. Eisai got FDA approval for Leqembi subcutaneous maintenance dosing. Chugai’s oral GLP-1 drug showed positive P3...

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

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

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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