Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

<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>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>Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.</li>
<li>Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.</li>
<li>FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.</li>
</ul>


Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.
Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.
FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.


APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

<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

Hong Kong

United Laboratories is a leading integrated pharmaceutical company engaged in the research, development, production, and sales of pharmaceutical products. Its diverse portfolio includes intermediate products, bulk medicines, finished products such as antibiotics and insulin, biopharmaceuticals, and animal healthcare products. The company was founded in 1990 and is headquartered in Hong Kong, with extensive manufacturing operations across China.

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United Laboratories (3933 HK)

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

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 (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 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

Celltrion signed KRW375B biologics CMO deal with a global pharma company. Samsung Bioepis expands biosimilar collaboration with Sandoz. 40+ Indian...

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

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