Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Xuanzhu Biopharmaceutical / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/xuanzhu-biopharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:44117:1" rel="noopener">Xuanzhu Biopharmaceutical (XUANZHU HK)</a> entered into a licensing and supply agreement with Boston Oncology giving them rights to develop, register and commercialize Bireociclib and Dirozalkib within the licensed territory.</li>
<li>Xuanzhu’s revenue in 2025 stood at RMB 51.8M (up 72% YoY). R&amp;D expenses witnessed a decrease of 33%, while losses narrowed by 56% YoY to RMB 245.5M in 2025.</li>
<li>2026 will be an inflection point for the company with all three core products fully commercialized, but will not be enough for the company to establish a sustainable market play.</li>
</ul>



Xuanzhu Biopharmaceutical (XUANZHU HK) entered into a licensing and supply agreement with Boston Oncology giving them rights to develop, register and commercialize Bireociclib and Dirozalkib within the licensed territory.
Xuanzhu’s revenue in 2025 stood at RMB 51.8M (up 72% YoY). R&amp;D expenses witnessed a decrease of 33%, while losses narrowed by 56% YoY to RMB 245.5M in 2025.
2026 will be an inflection point for the company with all three core products fully commercialized, but will not be enough for the company to establish a sustainable market play.


Xuanzhu Biopharmaceutical: Out Licensing Agreement A Positive, But Not Enough for a Sustainable Play

Thematic (Sector/Industry)

<ul>
<li>Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.</li>
<li>Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.</li>
<li>Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.</li>
</ul>


Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.
Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.
Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.


APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

<ul>
<li>InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.</li>
<li>Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.</li>
<li>Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.</li>
</ul>


InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.
Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.
Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.


APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

<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>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

China

Xuanzhu Biopharmaceutical is an innovation-driven biopharmaceutical company in China, specializing in the development, industrialization, and commercialization of small-molecule and macromolecular drugs. The company focuses on major therapeutic areas including digestive diseases, oncology, and non-alcoholic steatohepatitis (NASH), with key products like KBP-3571, XZP-3287, and XZP-3621. It is headquartered in Beijing, China, and was founded in 2002.

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Xuanzhu Biopharmaceutical (2575 HK)

Xuanzhu Biopharmaceutical: Out Licensing Agreement A Positive, But Not Enough for a Sustainable Play

Xuanzhu Biopharmaceutical signs licensing deal with Boston Oncology for Bireociclib and Dirozalkib. Revenue up 72% in 2025, but challenges ahead...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

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 (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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Xuanzhu Biopharmaceutical: Out Licensing Agreement A Positive, But Not Enough for a Sustainable Play

​Xuanzhu Biopharmaceutical signs licensing deal with Boston Oncology for Bireociclib and Dirozalkib. Revenue up 72% in 2025, but challenges ahead...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

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 (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

Xuanzhu Biopharmaceutical signs licensing deal with Boston Oncology for Bireociclib and Dirozalkib. Revenue up 72% in 2025, but challenges ahead...