Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical received approval for Benmelstobart plus Anlotinib for alveolar soft part sarcoma in China. Wuxi Biologics announced that three of its manufacturing facilities received GMP certification from South Korea.</li>
<li>Astellas Pharma has been granted Priority Review status by the FDA for indication expansion application for Padcev. Eisai’s Phase 3 trial evaluating Lenvima in RCC did not meet primary endpoints.</li>
<li>Celltrion started patient dosing for three of its novel ADC-based anticancer drug candidates. Cochlear has reduced FY26 underlying net profit guidance to A$290–330M from A$435–460M.</li>
</ul>


Sino Biopharmaceutical received approval for Benmelstobart plus Anlotinib for alveolar soft part sarcoma in China. Wuxi Biologics announced that three of its manufacturing facilities received GMP certification from South Korea.
Astellas Pharma has been granted Priority Review status by the FDA for indication expansion application for Padcev. Eisai’s Phase 3 trial evaluating Lenvima in RCC did not meet primary endpoints.
Celltrion started patient dosing for three of its novel ADC-based anticancer drug candidates. Cochlear has reduced FY26 underlying net profit guidance to A$290–330M from A$435–460M.


APAC Healthcare Weekly (April 26) – Sino Bio, Wuxi Bio, Astellas Pharma, Eisai, Celltrion, Cochlear

<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>Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.</li>
<li>Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.</li>
<li>Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.</li>
</ul>


Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.
Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.
Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.


APAC Healthcare Weekly (March 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

<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>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

Japan

Astellas Pharma Inc. is a pharmaceutical company committed to the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, euroscience and DM complications and metabolic diseases. The Company researches, develops, manufactures, and promotes its prescription drugs through subsidiaries in the US, Europe, and Asia.

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Astellas Pharma (4503 JT)

APAC Healthcare Weekly (April 26) – Sino Bio, Wuxi Bio, Astellas Pharma, Eisai, Celltrion, Cochlear

Sino Bio got fourth indication approval for Benmelstobart plus Anlotinib. Wuxi Biologics’ three facilities got Korean GMP certification. FDA...

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 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

Hansoh got trial approval, while CSPC obtained new drug approval. Chugai’s partner is discontinuing development of emugrobart. Otsuka is acquiring...

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 (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

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