Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.</li>
<li>Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.</li>
<li>Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.</li>
</ul>


Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.
Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.
Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.


APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

<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

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 (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 (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

Simcere stuck license pact with Vigonvita. Kelun Bio inked partnership with Crescent Biopharma. Samsung Biologics is acquiring land for third...

Tina Banerjee

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

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