Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Last week, the U.S. DoD designated Wuxi AppTec as a “Chinese military company.” In response, Wuxi AppTec has filed a complaint at the U.S. District Court.</li>
<li>CSPC Pharmaceutical received trial approval for semaglutide long-acting injection in U.S. Takeda’s TYK2 inhibitor zasocitinib tops BMS’ Sotyktu in head-to-head trial for clearing skin in patients with moderate-to-severe plaque psoriasis.</li>
<li>SK Bioscience initiated process development for injectable rotavirus vaccine candidate after entering license agreement with the U.S. CDC. Alteogen’s ALT-B4 received an Intention to Grant decision from European Patent Office.</li>
</ul>


Last week, the U.S. DoD designated Wuxi AppTec as a “Chinese military company.” In response, Wuxi AppTec has filed a complaint at the U.S. District Court.
CSPC Pharmaceutical received trial approval for semaglutide long-acting injection in U.S. Takeda’s TYK2 inhibitor zasocitinib tops BMS’ Sotyktu in head-to-head trial for clearing skin in patients with moderate-to-severe plaque psoriasis.
SK Bioscience initiated process development for injectable rotavirus vaccine candidate after entering license agreement with the U.S. CDC. Alteogen’s ALT-B4 received an Intention to Grant decision from European Patent Office.


APAC Healthcare Weekly (June 14) – Wuxi AppTec, Remegen, CSPC Pharma, Takeda, SK Bioscience Alteogen

<ul>
<li>Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.</li>
<li>FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.</li>
<li>Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.</li>
</ul>


Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.
FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.
Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.


APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

<ul>
<li>Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.</li>
<li>Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.</li>
<li>HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.</li>
</ul>


Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.
Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.
HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.


APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, 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>Fosun Pharma is acquiring 53% stake in Green Valley Pharmaceuticals for ~$200M, to bolster CNS portfolio. Hansoh Pharmaceutical entered an exclusive license agreement with Glenmark Pharma for NSCLC drug Ameile.</li>
<li>Daiichi Sankyo received FDA approval for Enhertu as first-line treatment for HER2+ breast cancer. Takeda Pharmaceutical announced positive topline results for two P3 studies of zasocitinib in moderate-to-severe plaque psoriasis.</li>
<li>Hanmi Pharmaceutical filed domestic marketing application for efpeglenatide autoinjector, the first domestically developed GLP-1-based obesity drug. Max Healthcare announced INR10B+ investment for a ~450 bedded hospital in Pune.</li>
</ul>


Fosun Pharma is acquiring 53% stake in Green Valley Pharmaceuticals for ~$200M, to bolster CNS portfolio. Hansoh Pharmaceutical entered an exclusive license agreement with Glenmark Pharma for NSCLC drug Ameile.
Daiichi Sankyo received FDA approval for Enhertu as first-line treatment for HER2+ breast cancer. Takeda Pharmaceutical announced positive topline results for two P3 studies of zasocitinib in moderate-to-severe plaque psoriasis.
Hanmi Pharmaceutical filed domestic marketing application for efpeglenatide autoinjector, the first domestically developed GLP-1-based obesity drug. Max Healthcare announced INR10B+ investment for a ~450 bedded hospital in Pune.


APAC Healthcare Weekly (December 21)–Fosun Pharma, Hansoh, Daiichi Sankyo, Takeda, Hanmi, Max Health

China

Laekna is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative therapies for cancer, metabolic diseases, and liver fibrosis. Its pipeline includes drug candidates such as LAE002 for breast and prostate cancer, LAE001 for prostate cancer, and LAE102 for obesity. The company was founded in 2016 and is headquartered in Yuyao, China.

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Laekna (2105 HK)

APAC Healthcare Weekly (June 14) – Wuxi AppTec, Remegen, CSPC Pharma, Takeda, SK Bioscience Alteogen

US DoD designated Wuxi AppTec as a “Chinese military company.” Takeda’s zasocitinib tops BMS’ Sotyktu in head-to-head trial. Alteogen secured...

Tina Banerjee

APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

FDA granted Priority Review to Daiichi Sankyo’s I-DXd. Astellas Pharma initiates Phase 3 study for setidegrasib. Telix and Regeneron...

Tina Banerjee

APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

Couple of Chinese companies got clinical trials approvals for their respective drug candidates. Astellas’ Phase 3 trial failed to meet primary...

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 (December 21)–Fosun Pharma, Hansoh, Daiichi Sankyo, Takeda, Hanmi, Max Health

Fosun Pharma is acquiring 53% stake in Green Valley. Hansoh inked exclusive license agreement with Glenmark Pharma. Daiichi Sankyo’s Enhertu got...

Tina Banerjee

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