Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/mesoblast-ltd" target="_blank" data-smartkarma-citation="entities:769:1" rel="noopener">Mesoblast Ltd (MSB AU)</a> has reported Q1FY26 product revenue of $20.6M, up from $12.9M in the previous quarter, with Ryoncil gross sales increasing 66% QoQ.</li>
<li>With mandatory state CMS coverage becoming effective as of July 1 in all U.S. states and Mesoblast completing onboarding of the remaining major U.S. transplant centers, Ryoncil revenue is accelerating.</li>
<li>Mesoblast ended September quarter with $145M in cash. Considering current pace of cash outgo, the company estimates that the current cash should provide runway of approximately 10 more quarters.</li>
</ul>



Mesoblast Ltd (MSB AU) has reported Q1FY26 product revenue of $20.6M, up from $12.9M in the previous quarter, with Ryoncil gross sales increasing 66% QoQ.
With mandatory state CMS coverage becoming effective as of July 1 in all U.S. states and Mesoblast completing onboarding of the remaining major U.S. transplant centers, Ryoncil revenue is accelerating.
Mesoblast ended September quarter with $145M in cash. Considering current pace of cash outgo, the company estimates that the current cash should provide runway of approximately 10 more quarters.


Mesoblast (MSB AU): Strong Q1 Result; Ryoncil Commercialization and Pipeline Progress Hold Key

<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>
<a href="https://www.smartkarma.com/entities/mesoblast-ltd" target="_blank" data-smartkarma-citation="entities:769:1" rel="noopener">Mesoblast Ltd (MSB AU)</a>  entered into convertible note subscription agreements with SurgCenter principals and existing shareholders, Gregory George and William Gueck, to issue up to $50M of unsecured convertible notes.</li>
<li>The maturity date of the convertible notes will be five years after the first issuance of notes. The convertible notes have a coupon of 5% p.a. on the face value.</li>
<li>Mesoblast recorded maiden revenue of $13.2M from Ryoncil in FY25. Current revenue stream is anticipated to expand based on Ryoncil performance for existing as well as upcoming indications.</li>
</ul>



Mesoblast Ltd (MSB AU)  entered into convertible note subscription agreements with SurgCenter principals and existing shareholders, Gregory George and William Gueck, to issue up to $50M of unsecured convertible notes.
The maturity date of the convertible notes will be five years after the first issuance of notes. The convertible notes have a coupon of 5% p.a. on the face value.
Mesoblast recorded maiden revenue of $13.2M from Ryoncil in FY25. Current revenue stream is anticipated to expand based on Ryoncil performance for existing as well as upcoming indications.


Mesoblast (MSB AU): Secures New Fund Amid Ongoing Commercialization of Ryoncil and Pipeline Progress

<ul>
<li>Wuxi XDC partnered with Akari Therapeutics to accelerate IND filing for Akari’s ADC program. Xuanzhu Biopharmaceutical entered licensing agreement with Boston Oncology for upfront and milestone payments of $100M+.</li>
<li>Shionogi secured $119M BARDA contract for manufacturing, procurement, and expanded development of Fetroja for biothreat-related infections. ABL Bio’s partner has received Orphan Drug Designation from the FDA for tovecimig.</li>
<li>PharmaEssentia signed an investment agreement for a new manufacturing facility in Puerto Rico. Max Healthcare Institute is acquiring 58.4% stake in 250-bedded Kalinga Hospital for INR3B.</li>
</ul>


Wuxi XDC partnered with Akari Therapeutics to accelerate IND filing for Akari’s ADC program. Xuanzhu Biopharmaceutical entered licensing agreement with Boston Oncology for upfront and milestone payments of $100M+.
Shionogi secured $119M BARDA contract for manufacturing, procurement, and expanded development of Fetroja for biothreat-related infections. ABL Bio’s partner has received Orphan Drug Designation from the FDA for tovecimig.
PharmaEssentia signed an investment agreement for a new manufacturing facility in Puerto Rico. Max Healthcare Institute is acquiring 58.4% stake in 250-bedded Kalinga Hospital for INR3B.


APAC Healthcare Weekly (April 12) – Wuxi XDC, Xuanzhu Biopharma, Shionogi, ABL Bio, PharmaEssentia

Australia

Mesoblast Limited provides biomedical services. The Company develops drugs for cardiovascular diseases, oncology, hematology, and spine orthopedic disorders treatment. Mesoblast conducts its business worldwide.

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Mesoblast Ltd (MSB AU)

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

Mesoblast (MSB AU): Strong Q1 Result; Ryoncil Commercialization and Pipeline Progress Hold Key

For the quarter ending December 31, 2025, Mesoblast expects gross revenue of $30M+ from sales of Ryoncil, up 37% QoQ. With mandatory state CMS...

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

Mesoblast (MSB AU): Secures New Fund Amid Ongoing Commercialization of Ryoncil and Pipeline Progress

Mesoblast touched another milestone for commercialization as Ryoncil got permanent J-code from CMS effective October 1, 2025, facilitiating...

Tina Banerjee

APAC Healthcare Weekly (April 12) – Wuxi XDC, Xuanzhu Biopharma, Shionogi, ABL Bio, PharmaEssentia

Wuxi XDC inked deal with Akari Therapeutics. Xuanzhu Bio entered licensing deal with Boston Oncology. Shionogi secured $119M BARDA contract for...

Tina Banerjee

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