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>CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.</li>
<li>Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.</li>
<li>SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.</li>
</ul>


CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.
Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.
SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.


APAC Healthcare Weekly (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

<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>NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.</li>
<li>FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.</li>
<li>Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.</li>
</ul>


NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.
FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.
Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.


APAC Healthcare Weekly (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

<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

China

Simcere Pharmaceutical Group is an innovation and R&D-driven pharmaceutical company engaged in the research, development, manufacturing, and sale of pharmaceutical products. It focuses on therapeutic areas such as oncology, central nervous system diseases, autoimmune diseases, and anti-infection, with key products including Sanbexin, Endostar, and Bicun. The company was founded in 1995 and is headquartered in Nanjing, China.

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Simcere Pharmaceutical (2096 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 (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

Innovent submitted NDA for oncology drug. Shionogi got FDA approval for Xocova. Hanmi Pharm signed $1.2B outlicensing deal with Lilly. SK...

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 (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

NMPA accepted Simcere’s resubmitted NDA for Rademikibart. Beigene got FDA’s priority review for label expansion of Tevimra. Sun Pharma is acquiring...

Tina Banerjee

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

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