Fosun Kite Biotechnology Co., Ltd.

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Gilead’s Kite Pharma is separating from its cell therapy joint venture with Fosun Pharma in China, handing Fosun the reins for its CAR-T therapy Yescarta in the region. Other foreign drugmakers have made recent China divestitures, including UCB and CSL Behring. Kite’s decision in particular reflects the challenges of securing reimbursement for more complex medicines in the country. Fosun is spending $27 million on Kite’s 50% share in the venture, known as Fosun Kite Biotechnology, according to a Sept. 13 securities filing in Chinese. Fosun will get the China rights to Yescarta and a related treatment called Tecartus. Kite will still be responsible for providing the viral vectors needed to continue making the two cell therapies. The Gilead subsidiary will also get tiered royalties on product sales ranging from 7% to 13%. The two drugmakers first inked their partnership in 2017, with Fosun paying Kite $40 million upfront and offering $35 million more in milestones for the China rights to Yescarta. The B cell lymphoma treatment was the first CAR-T to secure China approval in 2021. But since then, access and reimbursement for the CAR-T therapy have seen serious hurdles. Last year, Yescarta made sales of just 242 million Chinese yuan ($34 million), according to the filing. In the US, Yescarta made $186 million in the second quarter of this year. The treatment’s 1.2 million yuan ($170,000) price tag in China means it’s not affordable for many Chinese patients and likely ineligible for coverage under China’s state insurance program. In the US, Gilead initially set its list price at $373,000, but it has since increased to around $424,000. Fosun said it has tried to tap into various commercial coverage opportunities, including a scheme in Shanghai. Under that policy , insured patients can get a 100% claim payment for CAR-T therapy with a maximum coverage of 500,000 yuan. Several other companies besides Kite have also left China’s commercial activities to local drugmakers. Last month, CSL Behring sold a China subsidiary to Beijing Tiantan Biological Products for $185 million, according to a securities filing in Chinese. Just a few days before that, Belgium-based UCB sold a portfolio of its “mature products” to CBC Group and Abu Dhabi sovereign wealth fund Mubadala Investment Company for $680 million. Editor’s note: This article was updated to add further context.

Fosun Pharma plans to pay $27 million to buy Gilead Sciences' Kite Pharma out of its 50% stake in their Chinese joint venture. Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma.Fosun plans to pay $27 million to buy Kite out of its 50% share in Fosun Kite, the Chinese company said in a securities filing (PDF) to the Shanghai Stock Exchange on Sept. 13.The transaction will give Fosun full control in China over Yescarta, the star CD19-directed blood cancer therapy that was the first CAR-T therapy approved in China, plus its sister med Tecartus, which is undergoing bridging studies in the country.Kite’s exit from the Fosun JV comes as CAR-T meds continue to navigate patient access and reimbursement dynamics in China. In 2023, Fosun Kite recorded 242 million Chinese yuan ($34 million) in revenue, according to the filing. Relma-cel, a rival CD19 CAR-T drug, brought in 174 million yuan ($25 million) in sales last year.The list price for Yescarta in China is 1.2 million yuan (about $170,000). Although much cheaper than in the U.S., the cost is still astronomical for most Chinese families; China’s annual per capita disposable income last year was about one-thirtieth of that price. Since its approval in June 2021, Yescarta has treated more than 700 large B-cell lymphoma patients in China, according to Fosun Kite’s Website.CAR-T therapies’ high prices make them unlikely to qualify for national coverage under China's state-run insurance scheme.To help with access, Fosun Kite has over the years explored commercial insurance coverage, including a government-devised supplemental insurance program in Shanghai. Such policies have been able to cover up to 42% of the drug's cost, according to the company.And, in January, Fosun Kite worked with (Chinese) a subsidiary of state-run Sinopharm Group to roll out an outcomes-based payment program, offering half of a patient’s out-of-pocket cost back if Yescarta doesn’t induce a complete response by three months. To form the Chinese JV in early 2017, Fosun offered Kite $40 million in an upfront payment and committed $35 million in milestones for Yescarta’s rights in China, plus committed $20 million in initial funding for the new firm. The JV at the time had the option to license additional Kite candidates, including TCR therapies KITE-439 and KITE-718, both of which have since been discontinued at Kite.Now, Fosun said it will invest an additional $10 million in the cell therapy company.After the separation, Kite still grants Fosun rights to Yescarta and Tecartus in China and will supply the viral vectors used to manufacture the products. Kite will also get tiered royalties ranging from 7% to 13% of the drugs’ sales. For Fosun Kite’s pipeline assets, Kite is entitled to 2% to 4% of sales-based royalties if any ever reach the market. Kite’s decision to back out of the JV also follows a recent trend in which foreign pharmas are increasingly leaving management of their products—mostly established medicines—to local companies. Just last month, UCB said it will divest its mature neurology and allergy business in mainland China to local healthcare asset manager CBC Group and Abu Dhabi-based investment firm Mubadala. Days later, Sinopharm’s blood products subsidiary Beijing Tiantan Biological Products disclosed (PDF) that it’s buying a CSL Behring subsidiary in China for $185 million to obtain several albumin and human globulin products.