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>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

<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

China

Engages in research and development of therapeutics in the fields of immuno-oncology and immunology diseases

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HBM Holdings Limited (2142 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 (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

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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