Kite Pharma, Inc.

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

The Ministry of Health and Welfare (MHW) recently announced an implementation plan to improve the compensation price system for innovative new drugs, which aims to revise the current regulations on drug compensation and price setting. The proposal is currently under public consultation until Dec 16, 2024. Overall, the new reforms covered by the latest proposal could provide manufacturers with greater flexibility to handle drug reimbursement and pricing negotiations with South Korean authorities. Under the proposal, the Ministry of Health and Welfare plans to introduce two new risk-sharing agreements, namely fixed-cost initial treatment refunds and performance-based refunds, on top of four existing mechanisms. Under the fixed-cost initial treatment refund RSA, drug manufacturers would be required to return a certain amount of money for their products upon each patient receiving their first dose. As for the performance-based refund RSA, if the patient fails to achieve a certain clinical benefit after receiving the product, the manufacturer will need to repay the government. In addition to the two newly introduced RSA types, the existing RSA types in Korea are mandatory economic evaluation/spending caps, rebates, patient-level usage limits/usage caps, and a conditional continuing treatment type plus a money-back guarantee. Risk sharing agreements (RSAs) are a commonly used pricing and reimbursement strategy for insurance payers to control the future financial impact resulting from treatments with a high degree of uncertainty about clinical benefits or economic effects. Overall, the implementation of RSAs has had a positive impact on the pharmaceutical industry, implying that high-cost new therapies with highly uncertain cost-benefit outcomes can gain reimbursement status at an earlier stage under more flexible price negotiation strategies. GlobalData has identified at least 25 markets worldwide that use RSA mechanisms, both developed and emerging. South Korea introduced the RSA system in 2013. A total of 68 drugs have been introduced into South Korea's RSAs reimbursement list as of August 2023, according to an official at the National Health Insurance Service (NHIS), the pricing agency. In the Asia-Pacific region, several markets with comprehensive healthcare systems and established reimbursement systems for drugs already use RSAs under their national health insurance schemes. Australia, New Zealand, and Taiwan Province of China (along with South Korea) are prominent examples of widespread use of RSA in drug reimbursement decision-making processes. All four markets have formal RSA systems that can support access to national health insurance benefits for a drug at an early stage. There are seven RSA mechanisms in New Zealand, with rebates being the most commonly used RSA.NHIA also has the flexibility to accept other types of RSA. However, the two largest markets in Asia Pacific, China and Japan, have yet to implement official RSAs in their drug reimbursement decision-making process. Japan reimburses almost all prescription drugs under its national health insurance program and thus uses its strict repricing rules to control pharmaceutical spending. In the case of China, the coverage of the National Reimbursement Drug List (NRDL) is highly dependent on confidential price negotiations, in which case RSAs are less likely to be used. However, Chinese commercial firms use the RSA mechanism to reimburse for new high-cost treatments. Recently, Chinese drug developer Fosun Cate Biotech (China; A joint venture between Fosun Pharmaceutical and Kite Pharma) launched RSA of Yescarta (axicabtagene ciloleucel), a performance-based chimeric antigen receptor T-cell (CAR-T) therapy, This scheme was not included in the NRDL. As the RSA system in Korea is expected to be expanded under this reform, manufacturers with high-cost therapeutic products will have greater flexibility in reaching price agreements with NHIS. This will open up more opportunities for the pharmaceutical industry, while also providing patients with more treatment options.

Enriches Board's expertise in corporate strategy and business development, with vast experience leading biopharmaceutical companies through rapid growth and creating value across innovative therapeutic platforms, including cell therapy EMERYVILLE, Calif., Oct. 21, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the appointment of biotechnology executive and cell therapy veteran Mert Aktar as an independent director to its Board of Directors. Mr. Aktar has over two decades of biopharmaceutical experience, melding more than a decade of technical leadership in cell and gene therapy with a proven track record in corporate development. "We are delighted to welcome Mert to Kyverna's Board of Directors as we continue to advance KYV-101 into later stages of development and build on Kyverna's CAR T leadership in autoimmune diseases," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "Mert brings an impressive track record of building businesses and creating value through visionary operational leadership, strategic transactions and his understanding of drug development and manufacturing. Mert's strategic experience and deep technical expertise in cell therapy will be invaluable as we chart a course to bring the transformative power of CAR T treatments to as many patients as possible." Mr. Aktar currently serves as Chief Executive Officer of Receptive Bio, a privately held biotech company, and holds Board positions with UCLA Technology Development Group and ReAlta Life Sciences. Prior to joining Receptive Bio, Mr. Aktar was the Senior Vice President and Global Head of Corporate Development & Strategy at Kite Pharma. In this position, Mr. Aktar played a key role in establishing Kite's global leadership in cell therapy, architecting strategy and executing numerous deals, which strengthened Kite's R&D portfolio and drove its global expansion. Previously, Mr. Aktar held senior leadership positions at various biotech and large pharma organizations, across diverse modalities and therapeutic areas. Most notably, he helped shape Shire's transformation into a global rare disease leader, facilitating numerous multi-billion-dollar transactions as Global Head of Hematology and Immunology Business Development and earlier leading large-scale manufacturing operations as Global Head of Engineering. Mr. Aktar holds an M.B.A. from MIT Sloan School of Management, a B.S. in Chemical Engineering from Worcester Polytechnic Institute and an M.S. in Engineering Management from Tufts University. "I am thrilled to join the Board of Directors at this critical time in Kyverna's maturation and growth. CAR T is a powerful modality with the potential to revolutionize patient care. Kyverna stands at the forefront in bringing this innovation to patients with autoimmune disease, having already demonstrated encouraging efficacy and safety across initial datasets with KYV-101," said Mr. Aktar. "I look forward to working with the Kyverna Board and leadership to successfully advance the KYV-101 development program forward and scale the organization for future growth." About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the proposed contributions of Mr. Aktar on Kyverna's Board of Directors; Kyverna's prospects and ongoing clinical trials, KYV-101's safety, efficacy and commercial prospects; Kyverna's pipeline and the potential for Kyverna's CAR T-cell therapies to be well suited for use in B cell-driven autoimmune diseases. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, please visit . Contact: Precision AQ on behalf of Kyverna Therapeutics Investors: [email protected] Media: [email protected] SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED