Developer of Tumor Immune Cell Therapy Technologies and Products
Image Source: Fosun Pharmaceutical
After announcing the privatization of Henlius, Fosun Pharmaceutical, a leading pharmaceutical company in China, has made another significant transaction.After the transaction, a cell therapy subsidiary of Fosun PharmaceuticalFosun Kite is about to enter a brand-new stage of development.
As the announcement shows, this transaction will bring Fosun Kite into a brand-new stage of development.Specifically,Fosun Pharmaceutical's subsidiary, Fosun Pharmaceutical Industry, plans to acquire a 50% stake in Fosun Kite held by Kite Pharma through a cash investment. After the transfer is completed, Fosun Pharmaceutical will hold 100% of Fosun Kite’s equity and intends to make an additional cash investment of 10 million US dollars or an equivalent amount in RMB as the sole shareholder of Fosun Kite.
In addition to the 50% equity transfer portion of this transaction, Fosun Kite has also comprehensively revised and restated the original license agreement with Kite Pharma, reaching an "Amended and Restated License Agreement." According to the license agreement, Fosun Kite shall pay Kite Pharma up to US$35 million in milestone payments. Additionally, Fosun Kite will pay Kite Pharma royalties ranging from 7% to 13% based on the annual net sales of all licensed products within the licensed territory.
At the same time, after this transaction, Fosun Kite plans to be renamed "Fosun Kite Biotechnology Co., Ltd.", which will serve as Fosun Pharmaceutical's core platform for cell therapy technology, continuing to focus on the field of tumor immunotherapy. Fosun Pharmaceutical will also maintain a long-term strategic partnership with Kite Pharma through a licensing cooperation model.
It should be said that this transaction of Fosun Pharmaceutical is not surprising. In fact, over the past few years, Fosun Pharmaceutical has been carrying out asset integration and disposal with the aim of focusing on highly innovative core assets. AndFosun KiteIn China,CAR-TThe pioneer in cell therapy evidently aligns with this demand from Fosun Pharmaceutical.
Zhang Wenjie, Executive President of Fosun Pharmaceutical and Chairman of Fosun Kite, stated that Fosun Pharmaceutical has been implementing a strategy of asset reallocation and business focus, increasing its stake in core assets, continuously focusing on pharmaceuticals (such as Henlius, Fosun Kite, etc.), and continuously focusing on innovation (such as monoclonal antibodies, bispecific antibodies, ADC, peptides, cell therapy, etc.). Therefore, this time Fosun Pharmaceutical's full acquisition of Fosun Kite is both the implementation and practice of asset integration and resource integration, and it also aligns with Fosun Pharmaceutical's overall long-term strategy.
Zhang Wenjie also stated,This equity transfer has brought greater autonomous development space for Fosun Pharmaceutical and Fosun Kite,CompanyIn the future, it will be able to independently develop Fosun Kite's products. The company will not only continue to gain exclusive rights to develop, manufacture, and commercialize Yikaida® and Brexu-Cel (Fosun Kite's R&D project FKC889) in the field of cancer treatment within China, including Hong Kong and Macao, but also independently plan and build a strong CAR-T product pipeline through restructuring.。
It is not difficult to see,Fosun PharmaceuticalFutureWillToFosun Kite Biotechnology Co., Ltd. asBy oneself inCGTFieldCore PlatformTo carry out operations. This transaction, apart from retaining the original technical products of Fosun Kite, more importantly, means that the joint venture has become a wholly-owned subsidiary, which also indicates that Fosun Pharmaceutical places significant importance on Fosun Kite.RuiThe future development direction has absolute decision-making power, which also means that whether it is research and development, external cooperation, or within ChinaCAR-TThe most critical commercialization field in cell therapy, Fosun KiteRuiWill have a larger decision-making space than before.
It should be said that the biggest uniqueness of this transaction, which brings such a large room for imagination, lies inCAR-TThis product. On the one hand,CAR-T ProductsIt is a tumor product that can achieve "curability," differing from previous ones inExtend the median survival time of patientsCompared with traditional treatment methods for the main purpose, it can be said to be a classParadigm RevolutionProduct. And, currentlyCAR-TThe technology is still in the phase of rapid development and iteration. Apart from the currently more mature field of hematological tumors,CAR-TThe technology has demonstrated excellent therapeutic potential in fields such as solid tumors and autoimmune diseases, and its market prospects are immeasurable. This is also the reason why Fosun Pharmaceutical will inevitably invest in and operate Fosun Kite as a core asset. After Fosun Pharmaceutical achieves full ownership, these prospects will open up more quickly.
From the R&D perspective, Fosun Kite Biotechnology Co., Ltd. hasChina's First CAR-T Cell Therapy Product —— Yikaida® (Axicabtagene Ciloleucel Injection), and is one of the six products in ChinaCAR-T Cell Therapy ProductsThe only product approved for second-line lymphoma indications in China. To date, Yikaida® has established 170 high-standard treatment centers across 28 provinces, municipalities, and autonomous regions in China, successfully treating over 700 patients with relapsed or refractory lymphoma.
In addition,Fosun KiteThe two indications for Fosun Kite's second CD19-targeted CAR-T product (code name FKC889) were approved for clinical trials in China in February and December 2022, respectively. These include the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have received two or more prior lines of therapy, and relapsed or refractory adult precursor B-cell acute lymphoblastic leukemia (adult r/r ALL).
InIn the autoimmune pipeline, Fosun KiteSpecial AlreadyMultiple autologous CAR-T self-developed pipelines targeting BCMA/CD19 are in the preclinical stage, with IITs research being conducted on several autoimmune indications of exploratory value.
After Fosun Pharmaceutical achieved full ownership, Fosun KiteRuiAlsoWill fully leverage the autonomy and flexibility of innovative R&D, accelerate the pace of innovation in core pipelines, and continuously unleash innovative capabilities.Fosun Pharmaceutical, in addition to being able toContinue cooperation with Kite Pharma at a higher levelIn addition, this also lifts the restrictions on Fosun Kite's external cooperation. Considering Fosun Kite's mature product experience and Fosun Pharmaceutical's comprehensive commercialization capabilities, it is entirely reasonable to expect Fosun Pharmaceutical to initiate more diversified external product collaborations for Fosun Kite in the CGT field.
On the other hand, it is undeniable that,CAR-T ProductsAs an innovative product with an average price in the millions of RMB, it still faces many obstacles on the commercialization front in China that need to be resolved. The most significant one is that, as the largest payer for pharmaceuticals in China, several currently marketed products...CAR-TThe product has been delayed in being included in the national medical insurance reimbursement directory, which has significantly affected its accessibility.
After the transaction, Fosun Pharmaceutical will be able to have a say in commercialization matters such as pricing.Yikaida®With full decision-making power, there will be more room for discussion and feasibility regarding potential price adjustments, innovative payment methods, and especially the medical insurance payment model.
Zhang Wenjie introduced that, despiteYikaida®The number of patients being treated increases every year, but in fact, it is estimated that currently only 2% to 3% of patients in China are using such products, and the company alsoActively communicating with the medical insurance department and other government departments, hoping to use some innovative methods., inReduce CostsAt the same timeBe able to adopt some innovative payment models as early as possibleMakeMorePatients can benefit.
And this trend has actually become quite apparent.Previously, Fosun Kite Biotechnology Co., Ltd. actively promoted accessibility and recovery,At the beginning of this year, Fosun KiteA first in ChinaYikaida®Pay-for-Performance Plan，Explore a new development path for the payment model of high-value innovative drugs in China.Patients who voluntarily join the program and undergo PET-CT efficacy evaluation 3 months after receiving Yikaida infusion, if not reaching complete remission (CR), will be refunded half of their out-of-pocket expenses (up to 600,000 yuan).According to Zhang Wenjie's introduction,Since the launch of the project on January 1, 2024,Currently, nearly 200 patients have been enrolled in the program, with a complete response (CR) rate exceeding 58% among those who have completed efficacy evaluations. This further strengthens Fosun Pharmaceutical's confidence in the Yikaida product and its determination to advance innovative payment solutions.
For Fosun Pharmaceutical, after this transaction,Yikaida®This will also bring greater product synergy to Fosun Pharmaceutical's oncology pipeline.
In terms of product pipelines, Fosun Pharmaceutical has long possessed a mature small-molecule R&D platform, while in the area of large-molecule biologics, operations were historically conducted through Henlius. Now, with the privatization of Henlius and the completion of full ownership of Fosun Kite, Fosun Pharmaceutical has essentially achieved comprehensive coverage and platform-based operations in small molecules, large molecules, and CGT. Additionally, the company has made numerous strategic deployments in ADCs, peptides, and vaccines.
Overall,Fosun PharmaceuticalIn recent yearsHas been implementing the strategy of asset reallocation and business focus, increasing the holding of core assets. This transaction is also a landing of this strategic direction. FosunKiteAs an important innovative asset within the company's system, its commercial product Yikaida boasts strong innovative attributes, and its commercialization process is proceeding steadily. Bringing it under full ownership aligns with the company's long-term strategy of focusing on innovative drugs.
Fosun Pharmaceutical's interim report shows,In the first half of 2024, Fosun Pharmaceutical's innovative drug revenue exceeded 3.7 billion yuan, maintaining steady growth. Through this transaction, Fosun Pharmaceutical continues to strengthen its layout in hematological oncology, constantly enriching its innovative drug portfolio and increasing the revenue share of high-margin and high-profit products. In addition, Fosun Pharmaceutical can further integrate resources for the R&D, production, registration, and commercialization of innovative drugs, accelerating the clinical development and regulatory approval process, and continuously promoting the market launch of innovative products.
After announcing the privatization of Henlius, Fosun Pharmaceutical, a leading pharmaceutical company in China, has made another significant transaction.After the transaction, a cellular therapy subsidiary of Fosun PharmaceuticalFosun Kite is about to enter a brand-new stage of development.
As the announcement shows, this transaction will bring Fosun Kite into a brand-new stage of development.Specifically,Fosun Pharmaceutical's subsidiary, Fosun Pharmaceutical Industry, plans to acquire a 50% stake in Fosun Kite held by Kite Pharma through a cash investment. After the transfer is completed, Fosun Pharmaceutical will hold 100% of Fosun Kite’s shares and intends to make an additional capital contribution of 10 million US dollars or an equivalent amount in RMB as the sole shareholder.
In addition to the 50% equity transfer portion of this transaction, Fosun Kite has also comprehensively revised and restated the original licensing agreement with Kite Pharma, reaching an "Amended and Restated Licensing Agreement." According to the licensing agreement, Fosun Kite shall pay Kite Pharma up to US$35 million in milestones. Furthermore, Fosun Kite will pay royalties to Kite Pharma at varying rates of 7%-13% based on the annual net sales of all licensed products within the licensed territory.
At the same time, after this transaction, Fosun Kite plans to be renamed "Fosun Kite Biotechnology Co., Ltd.," which will serve as Fosun Pharmaceutical's core platform for cell therapy technology, continuing to focus on the field of tumor immunotherapy. Fosun Pharmaceutical will also maintain a long-term strategic partnership with Kite Pharma through a licensing cooperation model.
It should be said that this transaction of Fosun Pharmaceutical is not surprising. In fact, over the past few years, Fosun Pharmaceutical has been carrying out asset integration and disposal with the aim of focusing on highly innovative core assets. AndFosun KiteIn China,CAR-TThe pioneer in cell therapy evidently aligns with this demand from Fosun Pharmaceutical.
Zhang Wenjie, Executive President of Fosun Pharmaceutical and Chairman of Fosun Kite, stated that Fosun Pharmaceutical has been implementing a strategy of asset reallocation and business focus, increasing its stake in core assets, continuously focusing on pharmaceuticals (such as Henlius, Fosun Kite, etc.), and continuously focusing on innovation (such as monoclonal antibodies, bispecific antibodies, ADCs, peptides, cell therapy, etc.). Therefore, this full acquisition of Fosun Kite by Fosun Pharmaceutical is both the implementation and practice of asset integration and resource integration, and also aligns with Fosun Pharmaceutical's overall long-term strategy.
Zhang Wenjie also stated,This equity transfer has brought greater autonomous development space for Fosun Pharmaceutical and Fosun Kite Biotechnology Co., Ltd., enablingCompanyIn the future, it will be able to independently develop Fosun Kite's products. The company will not only continue to gain exclusive rights to develop, manufacture, and commercialize Yikaida® and Brexu-Cel (Fosun Kite's research project FKC889) in the cancer treatment field within China and the Hong Kong and Macao regions, but also, through restructuring, independently plan and build a robust CAR-T product pipeline.。
It is not difficult to see,Fosun PharmaceuticalFutureWillToFosun Kite Biotechnology Co., Ltd. asOn one's own inCGTFieldCore PlatformTo carry out operations. This transaction, apart from retaining the original technical products of Fosun Kite, more importantly, means that Fosun Pharmaceutical has transformed the joint venture into a wholly-owned subsidiary, which also indicates Fosun Pharmaceutical's strengthened position regarding Fosun Kite.RuiThe future development direction has absolute decision-making power, which also means that whether it is research and development, external cooperation, or within ChinaCAR-TThe most critical commercialization field in cell therapy, Fosun KiteRuiWill have a larger decision-making space than before.
It should be said that the biggest uniqueness of this deal, which brings such a large room for imagination, lies inCAR-TThis product. On the one hand,CAR-T ProductsIt is a tumor product that can achieve "curability," unlike previous products thatProlong the median survival time of patientsCompared with traditional treatment methods for the main purpose, it can be said to be a classParadigm RevolutionProduct. And, currentlyCAR-TThe technology is still in the phase of rapid development and iteration. Apart from the currently more mature field of hematological tumors,CAR-TThe technology has demonstrated excellent therapeutic potential in fields such as solid tumors and autoimmune diseases, and its market prospects are immeasurable. This is also the reason why Fosun Pharmaceutical will inevitably invest in and operate Fosun Kite as a core asset. After Fosun Pharmaceutical achieves full ownership, these prospects will open up more quickly.
From the R&D perspective, Fosun Kite Biotechnology Co., Ltd. possessesChina's First CAR-T Cell Therapy Product —— Yikaida® (Axicabtagene Ciloleucel Injection), and is one of the six products in ChinaCAR-T Cell Therapy ProductsThe only product approved for second-line lymphoma indications in China. Currently, Yikaida® has established 170 high-standard treatment centers across 28 provinces, municipalities, and autonomous regions in China, successfully treating over 700 patients with relapsed or refractory lymphoma.
In addition,Fosun KiteThe two indications for FKC889, Fosun Kite's second CD19-targeted CAR-T product, were approved for clinical trials in China in February and December 2022, respectively. These include the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have received two or more prior lines of therapy, and adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (adult r/r ALL).
InIn the self-immune pipeline, Fosun KiteSpecial AlreadyMultiple autologous CAR-T self-developed pipelines targeting BCMA/CD19 are in the preclinical stage, and IITs research is being conducted for several autoimmune indications with exploratory value.
After Fosun Pharmaceutical achieved full ownership, Fosun KiteRuiAlsoWill fully leverage the autonomy and flexibility of innovative R&D, accelerate the pace of innovative R&D in core pipelines, and continuously unleash innovation capabilities.Fosun Pharmaceutical, in addition to being able toContinue cooperation with Kite Pharma at a higher levelIn addition, this also lifts the restrictions on external cooperation for Fosun Kite. Considering Fosun Kite's mature product experience and Fosun Pharmaceutical's comprehensive commercialization capabilities, it is entirely reasonable to expect that Fosun Pharmaceutical will engage in more diversified external product collaborations for Fosun Kite in the CGT field.
On the other hand, it is undeniable that,CAR-T ProductsAs an innovative product with an average price in the millions of RMB, it currently still faces many obstacles on the commercialization front in China that need to be addressed. The most significant issue is that, as the largest payer for pharmaceuticals in China, several products already on the market...CAR-TThe product has been delayed in being included in the national medical insurance reimbursement directory, which has significantly affected its accessibility.
After the transaction, Fosun Pharmaceutical will be able to have a say in commercialization matters such as pricing.Yikaida®With full decision-making power, there will be more room for discussion and feasibility regarding potential price adjustments, innovative payment methods, and especially the medical insurance payment model.
Zhang Wenjie introduced that, despiteYikaida®The number of patients being treated increases every year, but in fact, it is estimated that currently only 2% to 3% of patients in China use such products, and the company alsoActively communicating with the medical insurance and other government departments, hoping to use some innovative methods, inReduce CostsAt the same timeTo be able to adopt some innovative payment models as early as possibleMakeMorePatients can benefit.
And this trend has actually become quite apparent.Previously, Fosun Kite Biotechnology Co., Ltd. actively promoted accessibility and recovery,At the beginning of this year, Fosun KitePioneered in ChinaYikaida®Pay-for-Performance Plan，Explore a new development path for the payment model of high-value innovative drugs in China.Patients who voluntarily join the program and undergo PET-CT efficacy evaluation 3 months after receiving Yikaida infusion, if they do not reach the complete remission (CR) status, will be refunded half of their out-of-pocket expenses (up to 600,000 yuan).According to Zhang Wenjie's introduction,Since the launch of this project on January 1, 2024,Nearly 200 patients have been enrolled in the program so far, with a complete response (CR) rate exceeding 58% among those who have completed efficacy evaluations. This further strengthens Fosun Pharmaceutical's confidence in the Yikaida product and its determination to advance innovative payment solutions.
For Fosun Pharmaceutical, after this transaction,Yikaida®This will also bring greater product synergy to Fosun Pharmaceutical's oncology pipeline.
In terms of the product pipeline, Fosun Pharmaceutical has long possessed a mature small-molecule R&D platform, while in the area of large-molecule biologics, operations were historically conducted through Henlius. Now, with the privatization of Henlius and the full acquisition of Fosun Kite, Fosun Pharmaceutical has essentially completed comprehensive coverage and platform-based operations in small molecules, large molecules, and CGT. Additionally, the company has made numerous strategic deployments in ADCs, peptides, and vaccines.
Overall,Fosun PharmaceuticalIn recent yearsHas been implementing the strategy of asset reallocation and business focus, increasing the holding of core assets. This transaction is also a landing of this strategic direction. FosunKiteAs an important innovative asset within the company's system, its commercial product Yikaida boasts strong innovative attributes, and its commercialization process is proceeding steadily. Bringing it under full ownership aligns with the company's long-term strategy of focusing on innovative drugs.
Fosun Pharmaceutical's interim report shows,In the first half of 2024, Fosun Pharmaceutical's innovative drug revenue exceeded 3.7 billion yuan, maintaining steady growth. Through this transaction, Fosun Pharmaceutical continues to strengthen its hematology oncology portfolio, enriching its innovative drug pipeline and increasing the revenue share of high-margin and high-profit products. Additionally, Fosun Pharmaceutical can further integrate resources for the R&D, production, registration, and commercialization of innovative drugs, accelerating the clinical development and regulatory approval process, while continuously driving the market launch of innovative products.
Image Source: Fosun Pharmaceutical
After announcing the privatization of Fosun Henlius, Fosun Pharmaceutical, a leading pharmaceutical company in China, has made another major deal.After the transaction, Fosun Pharmaceutical's cell therapy subsidiaryFosun Kite is about to enter a brand-new stage of development.
As the announcement shows, this transaction will lead to a new stage of development for Fosun Kite.Specifically,Fosun Pharmaceutical's subsidiary, Fosun Pharmaceutical Industry, plans to acquire a 50% stake in Fosun Kite held by Kite Pharma through a cash investment. After the completion of the transfer, Fosun Pharmaceutical will hold 100% of Fosun Kite’s shares and intends to make an additional capital injection of US$10 million or its equivalent in RMB as the sole shareholder.
In addition to the 50% equity transfer portion of this transaction, Fosun Kite has also comprehensively revised and restated the original license agreement with Kite Pharma, reaching an "Amended and Restated License Agreement." According to the license agreement, Fosun Kite should pay Kite Pharma up to 35 million U.S. dollars in milestones. Meanwhile, for the annual net sales of all licensed products within the licensed territory, Fosun Kite will pay Kite Pharma royalties at varying rates of 7%-13%.
At the same time, after this transaction, Fosun Kite plans to be renamed "Fosun Kyrive" and will serve as Fosun Pharmaceutical's core platform for cell therapy technology, continuing to focus on the field of tumor immunotherapy. Fosun Pharmaceutical will also maintain a long-term strategic partnership with Kite Pharma through a licensing cooperation model.
It should be said that this transaction of Fosun Pharmaceutical is not surprising. In fact, over the past few years, Fosun Pharmaceutical has been continuously carrying out asset integration and disposal with the aim of focusing on highly innovative core assets. AndFosun KiteIn China,CAR-TThe pioneer in cell therapy evidently aligns with this demand from Fosun Pharmaceutical.
Zhang Wenjie, Executive President of Fosun Pharmaceutical and Chairman of Fosun Kite, stated that Fosun Pharmaceutical has been implementing a strategy of asset reallocation and business focus, increasing its stake in core assets, continuously focusing on pharmaceuticals (such as Henlius, Fosun Kite, etc.), and continuously focusing on innovation (such as monoclonal antibodies, bispecific antibodies, ADC, peptides, cell therapy, etc.). Therefore, this time Fosun Pharmaceutical's full acquisition of Fosun Kite is both the implementation and practice of asset integration and resource integration, and it also aligns with Fosun Pharmaceutical's overall long-term strategy.
Zhang Wenjie also stated,This equity transfer has brought greater autonomous development space for Fosun Pharmaceutical and Fosun Kite, enablingCompanyIn the future, it will be able to independently develop Fosun Kite's products. The company will not only continue to gain exclusive rights to develop, produce, and commercialize Yikaida® and Brexu-Cel (Fosun Kite's research project FKC889) in the field of cancer treatment within China and the Hong Kong and Macao regions, but also, through restructuring, independently plan and build a strong CAR-T product pipeline.。
It is not difficult to see,Fosun PharmaceuticalFutureWillPutFosun Kite Biotechnology Co., Ltd. asOn one's own inCGTFieldCore PlatformTo carry out operations. This transaction, in addition to retaining Fosun Kite's original technical products, more importantly, the change from a joint venture to a wholly-owned subsidiary also means that Fosun Pharmaceutical has...RuiThe future development direction has absolute decision-making power, which also means that whether it is research and development, external cooperation, or within ChinaCAR-TThe most critical commercialization area in cell therapy, Fosun KiteRuiWill have a larger decision-making space than before.
It should be said that the biggest uniqueness of this transaction, which brings such a large room for imagination, lies inCAR-TThis product. On the one hand,CAR-T ProductsIt is a tumor product that can achieve "curability," unlike previous products thatProlong the median survival time of patientsCompared with traditional treatment methods for the main purpose, it can be said to be a classParadigm RevolutionProduct. And, currentlyCAR-TThe technology is still in the phase of rapid development and iteration. Apart from the currently more mature field of hematological tumors,CAR-TThe technology has demonstrated excellent therapeutic potential in fields such as solid tumors and autoimmune diseases, and its market prospects are immeasurable. This is also the reason why Fosun Pharmaceutical will inevitably invest in and operate Fosun Kite as a core asset. After Fosun Pharmaceutical achieves full ownership, these prospects will open up more quickly.
From the R&D perspective, Fosun Kite Biotechnology Co., Ltd. possessesChina's First CAR-T Cell Therapy Product —— Yikaida® (Axicabtagene Ciloleucel Injection), and is one of the six products in ChinaCAR-T Cell Therapy ProductsThe only product approved for second-line lymphoma indications in China. Currently, Yikaida® has established 170 high-standard treatment centers across 28 provinces, municipalities, and autonomous regions in China, successfully treating over 700 patients with relapsed or refractory lymphoma.
In addition,Fosun KiteThe two indications for FKC889, Fosun Kite's second CAR-T product targeting CD19 (code name FKC889), were approved to conduct clinical trials in China in February and December 2022, respectively. These include the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have previously received second-line or above treatment; and relapsed or refractory adult precursor B-cell acute lymphoblastic leukemia (adult r/r ALL).
InIn the autoimmune pipeline, Fosun KiteSpecial AlreadyMultiple autologous CAR-T self-developed pipelines targeting BCMA/CD19 are in the preclinical stage, with IITs research being conducted on several autoimmune indications of exploratory value.
After Fosun Pharmaceutical achieved full ownership, Fosun KiteRuiAlsoWill fully leverage the autonomy and flexibility of innovative R&D, accelerate the pace of innovation in core pipelines, and continuously unleash innovative capabilities.Fosun Pharmaceutical, in addition to being able toContinue cooperation with Kite Pharma at a higher levelIn addition, this also essentially removes the constraints on Fosun Kite's external collaborations. Considering Fosun Kite's mature product experience and Fosun Pharmaceutical's comprehensive commercialization capabilities, it is entirely reasonable to expect that Fosun Pharmaceutical will initiate more diversified external product collaborations for Fosun Kite in the CGT field.
On the other hand, it is undeniable that,CAR-T ProductsAs an innovative product with an average price in the millions of RMB, it still faces many obstacles on the commercialization front in China that need to be addressed. The most significant one is that, as the largest payer for pharmaceuticals in China, several products already on the market...CAR-TThe product's delayed inclusion in the national medical insurance reimbursement directory has also significantly impacted its accessibility.
Following the transaction, Fosun Pharmaceutical will be able to participate in commercialization matters such as pricing.Yikaida®With full decision-making power, there will be greater room for discussion and feasibility regarding potential price adjustments, innovative payment methods, and especially the medical insurance payment model.
Zhang Wenjie introduced that, despiteYikaida®The number of patients being treated is increasing every year, but in fact, it is estimated that currently only 2% to 3% of patients in China are using such products, and the company alsoActively communicating with the medical insurance and other government departments, hoping to use some innovative methods., inReduce CostsAt the same timeTo be able to adopt some innovative payment models as early as possibleMakeMorePatients can benefit.
And this trend has actually become quite apparent.Previously, Fosun Kite Biotechnology Co., Ltd. actively promoted accessibility and recovery,At the beginning of this year, Fosun KitePioneered in ChinaYikaida®Pay-for-Performance Plan，Explore a new development path for the payment model of high-value innovative drugs in China.Patients who voluntarily join the program and undergo PET-CT efficacy evaluation 3 months after receiving Yikaida infusion will be refunded half of their out-of-pocket expenses (up to 600,000 yuan) if complete remission (CR) is not achieved.According to Zhang Wenjie's introduction,Since the launch of the project on January 1, 2024,Currently, nearly 200 patients have been enrolled in the program, with a complete response (CR) rate exceeding 58% among patients who have completed efficacy evaluations. This further strengthens Fosun Pharmaceutical's confidence in the Yikaida product and its determination to advance innovative payment solutions.
For Fosun Pharmaceutical, after this transaction,Yikaida®This will also bring greater product synergy to Fosun Pharmaceutical's oncology pipeline.
In terms of the product pipeline, Fosun Pharmaceutical has long possessed a mature small-molecule R&D platform, while in the area of large-molecule biologics, operations were historically conducted through Henlius. Now, with the privatization of Henlius and the full acquisition of Fosun Kite, Fosun Pharmaceutical has essentially completed comprehensive coverage and platform-based operations in small molecules, large molecules, and CGT (cell and gene therapy). Additionally, the company has made numerous strategic deployments in ADCs (antibody-drug conjugates), peptides, and vaccines.
Overall,Fosun PharmaceuticalIn recent yearsHas been implementing the strategy of asset reallocation and business focus, increasing the holding of core assets. This transaction is also a落地 of this strategic direction. FosunKiteAs an important innovative asset within the company's system, its commercial product Yikaida boasts strong innovative attributes, and its commercialization process is proceeding steadily. Bringing it under full ownership aligns with the company's long-term strategy of focusing on innovative drugs.
Fosun Pharmaceutical's interim report shows,In the first half of 2024, Fosun Pharmaceutical's innovative drug revenue exceeded 3.7 billion yuan, maintaining steady growth. Through this transaction, Fosun Pharmaceutical continues to strengthen its layout in hematological oncology, constantly enriching its innovative drug portfolio and increasing the revenue share of high-margin and high-profit products. In addition, Fosun Pharmaceutical can further integrate resources for the R&D, production, registration, and commercialization of innovative drugs, accelerating the clinical development and regulatory approval process of projects, and continuously promoting the market launch of innovative products.
After announcing the privatization of Fosun Henlius, China's leading pharmaceutical company Fosun Pharmaceutical has made another major deal.After the transaction, a cellular therapy subsidiary of Fosun PharmaceuticalFosun Kite is about to enter a brand-new stage of development.
As announced, this transaction will mark a new phase of development for Fosun Kite.Specifically,Fosun Pharmaceutical's subsidiary, Fosun Pharma Industry, plans to acquire a 50% stake in Fosun Kite held by Kite Pharma through a cash investment. After the transfer is completed, Fosun Pharmaceutical will hold 100% of Fosun Kite’s equity and intends to inject an additional capital contribution of US$10 million or an equivalent amount in RMB as the sole shareholder.
In addition to the 50% equity transfer portion of this transaction, Fosun Kite has also comprehensively revised and restated the original license agreement with Kite Pharma, reaching an "Amended and Restated License Agreement." According to the license agreement, Fosun Kite should pay Kite Pharma up to 35 million U.S. dollars in milestones. Meanwhile, for the annual net sales of all licensed products within the licensed territory, Fosun Kite will pay Kite Pharma royalties at varying rates of 7%-13%.
At the same time, after this transaction, Fosun Kite plans to be renamed "Fosun Kery," which will serve as Fosun Pharmaceutical's core platform for cell therapy technology, continuing to focus on the field of tumor immunotherapy. Fosun Pharmaceutical will also maintain a long-term strategic partnership with Kite Pharma through a licensing cooperation model.
It should be said that this transaction of Fosun Pharmaceutical is not surprising. In fact, over the past few years, Fosun Pharmaceutical has been continuously carrying out asset integration and disposal with the aim of focusing on highly innovative core assets. AndFosun KiteIn China,CAR-TThe pioneer in cell therapy evidently aligns with this demand from Fosun Pharmaceutical.
Zhang Wenjie, Executive President of Fosun Pharmaceutical and Chairman of Fosun Kite, stated that Fosun Pharmaceutical has been implementing a strategy of asset reallocation and business focus, increasing its stake in core assets, continuously focusing on pharmaceuticals (such as Henlius, Fosun Kite, etc.), and continuously focusing on innovation (such as monoclonal antibodies, bispecific antibodies, ADCs, peptides, cell therapy, etc.). Therefore, this time Fosun Pharmaceutical's full acquisition of Fosun Kite is not only the implementation and practice of asset integration and resource integration but also aligns with Fosun Pharmaceutical's overall long-term strategy.
Zhang Wenjie also stated,This equity transfer has brought greater autonomous development space for Fosun Pharmaceutical and Fosun Kite, enablingCompanyIn the future, it will be able to independently develop Fosun Kite's products. The company will not only continue to gain exclusive rights to develop, manufacture, and commercialize Yikaida® and Brexu-Cel (Fosun Kite's R&D project FKC889) in the field of cancer treatment within China and the Hong Kong and Macao regions, but will also, through restructuring, independently plan and build a robust CAR-T product pipeline.。
It is not difficult to see,Fosun PharmaceuticalFutureWillPutFosun Kite Biotechnology Co., Ltd. asBy oneself inCGTFieldCore PlatformOperations will be carried out. This transaction, apart from retaining the original technical products of Fosun Kite, more importantly, the change from a joint venture to a wholly-owned subsidiary also means that Fosun Pharmaceutical places significant importance on Fosun Kite.RuiThe absolute decision-making power for future development directions also means that, whether it's research and development, external cooperation, or within China,CAR-TThe most critical commercialization area in cell therapy, Fosun KiteRuiWill have a larger decision-making space than before.
It should be said that the biggest uniqueness of this deal, which brings such a large room for imagination, lies inCAR-TThis product. On the one hand,CAR-T ProductsIt is a tumor product that can achieve "curability," unlike previous products thatExtend the median survival time of patientsCompared with traditional treatment methods for the main purpose, it can be said to be a classParadigm RevolutionProduct. And, currentlyCAR-TThe technology is still in the phase of rapid development and iteration. Apart from the currently more mature field of hematological tumors,CAR-TThe technology has demonstrated excellent therapeutic potential in fields such as solid tumors and autoimmune diseases, and its market prospects are immeasurable. This is also the reason why Fosun Pharmaceutical will inevitably invest in and operate Fosun Kite as a core asset. After Fosun Pharmaceutical achieves full ownership, these prospects will open up more quickly.
From the R&D perspective, Fosun Kite Biotechnology Co., Ltd. possessesChina's First CAR-T Cell Therapy Product —— Yikaida® (Axicabtagene Ciloleucel Injection)`, and is one of the six products in China`CAR-T Cell Therapy ProductsThe only product approved for second-line lymphoma indications in China. Currently, Yikaida® has established 170 high-standard treatment centers across 28 provinces, municipalities, and autonomous regions in China, successfully treating over 700 patients with relapsed or refractory lymphoma.
In addition,Fosun KiteThe two indications for FKC889, Fosun Kite's second CAR-T product targeting CD19 (code name FKC889), were approved for clinical trials in China in February and December 2022, respectively. These include the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have received two or more prior lines of therapy, and adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (adult r/r ALL).
InIn the self-immune pipeline, Fosun KiteSpecial AlreadyMultiple autologous CAR-T self-developed pipelines targeting BCMA/CD19 are in the preclinical stage, and IITs research is being conducted for several autoimmune indications with exploratory value.
After Fosun Pharmaceutical took full control, Fosun KiteRuiAlsoWill fully leverage the autonomy and flexibility of innovative R&D, accelerate the pace of innovation in core pipelines, and continuously unleash innovative capabilities.Fosun Pharmaceutical, in addition to being able toContinue cooperation with Kite Pharma at a higher levelIn addition, this also equals to lifting the restrictions on Fosun Kite's external cooperation. Considering Fosun Kite's mature product experience and Fosun Pharmaceutical's comprehensive commercialization capabilities, it is entirely reasonable to expect that Fosun Pharmaceutical will initiate more diversified external product collaborations for Fosun Kite in the CGT field.
On the other hand, it is undeniable that,CAR-T ProductsAs an innovative product with an average price in the millions of RMB, it currently still faces many obstacles to commercialization in China that need to be addressed. The most significant issue is that, as the largest payer for pharmaceuticals in China, several products already on the market...CAR-TThe product has been unable to be included in the national medical insurance reimbursement directory for a long time, which has significantly affected its accessibility.
After the transaction, Fosun Pharmaceutical will be able to have a say in commercialization matters such as pricing.Yikaida®With full decision-making power, there will be more room for discussion and feasibility regarding potential price adjustments, innovative payment methods, and especially the medical insurance payment model.
Zhang Wenjie introduced that, despiteYikaida®The number of patients receiving treatment increases every year, but in fact, it is estimated that currently only 2% to 3% of patients in China use such products, and the company alsoActively communicating with the medical insurance and other government departments, hoping to use some innovative methods., inReduce CostsAt the same timeTo be able to adopt some innovative payment models as early as possibleMakeMorePatients can benefit.
And this trend has actually become quite apparent.Previously, Fosun Kite Biotechnology Co., Ltd. actively promoted accessibility and cure.At the beginning of this year, Fosun KitePioneered in ChinaYikaida®Pay-for-Performance Plan，Explore a new development path for the payment model of high-value innovative drugs in China.Patients who voluntarily join the program and undergo PET-CT efficacy evaluation 3 months after receiving Yikaida infusion will be refunded half of their out-of-pocket expenses (up to 600,000 yuan) if complete remission (CR) is not achieved.According to Zhang Wenjie's introduction,Since the launch of the project on January 1, 2024,Nearly 200 patients have been enrolled in the program so far, with a complete response (CR) rate exceeding 58% among those who have completed efficacy evaluations. This further strengthens Fosun Pharmaceutical's confidence in the Yikaida product and its determination to advance innovative payment solutions.
As for Fosun Pharmaceutical, after this transaction,Yikaida®This will also bring greater product synergy to Fosun Pharmaceutical's oncology pipeline.
From the product pipeline perspective, Fosun Pharmaceutical has long maintained a mature small-molecule R&D platform, while operations in large-molecule biologics were historically conducted through Henlius. Now, with the privatization of Henlius and the full acquisition of Fosun Kite, Fosun Pharmaceutical has essentially achieved comprehensive coverage and platform-based operations across small molecules, large molecules, and CGT. Additionally, the company has made numerous strategic investments in areas such as ADCs, peptides, and vaccines.
Overall,Fosun PharmaceuticalIn recent yearsHas been implementing the strategy of asset reallocation and business focus, increasing the holding of core assets. This transaction is also a落地 of this strategic direction. FosunKiteAs an important innovative asset within the company's system, its commercial product Yikaida boasts strong innovative attributes, and its commercialization process is proceeding steadily. Bringing it under full ownership aligns with the company's long-term strategy of focusing on innovative drugs.
Fosun Pharmaceutical's interim report shows,In the first half of 2024, Fosun Pharmaceutical's innovative drug revenue exceeded 3.7 billion yuan, maintaining steady growth. Through this transaction, Fosun Pharmaceutical continues to strengthen its layout in hematological oncology, enriching its innovative drug portfolio and increasing the revenue share of high-margin and high-profit products. Additionally, Fosun Pharmaceutical can further integrate resources for the R&D, production, registration, and commercialization of innovative drugs, accelerating the clinical development and regulatory approval process, and continuously promoting the market launch of innovative products.
