Fosun Pharma Announces 2024Q3 Financial Results

On October 29, 2024 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), reported its operating performance for the first three quarters of 2024 (Press release, Fosun Pharma, OCT 29, 2024, View Source [SID1234647502]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (Free ESMO Whitepaper) 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.

Biond Biologics Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany to Evaluate BND-35 in Combination with Cetuximab in a Phase 1 Clinical Study in Patients with Solid Tumors

On October 29, 2024 Biond Biologics Ltd. ("Biond" or the "Company"), a private clinical-stage biopharmaceutical company focusing on novel immunotherapies for cancer and innovative platforms for the intracellular delivery of biologics, reported a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, to evaluate its immunotherapy agent BND-35 in combination with Merck KGaA, Darmstadt, Germany’s anti-EGFR monoclonal antibody cetuximab (Erbitux) in a Phase 1 clinical trial (BND-35-001, NCT06274437) for the treatment of patients with unresectable or metastatic solid tumors (Press release, Biond Biologics, OCT 29, 2024, View Source [SID1234647499]). Under the terms of this agreement, Merck KGaA, Darmstadt, Germany will supply Biond Biologics with cetuximab to support Biond’s Phase 1 clinical trial, aimed at evaluating the safety and efficacy of BND-35 in combination with cetuximab. Enrollment to the BND-35 dose-escalation monotherapy arm has already begun and several patients have already been dosed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BND-35 is a novel anti-ILT3 (LILRB4) antibody that inhibits the interaction between ILT3 and various extracellular matrix ligands, including fibronectin, a major component of many tumor microenvironments (TME). ILT3 is expressed on myeloid suppressive cells and contributes to a pro-tumorigenic TME. Additionally, ILT3 reduces the effectiveness of targeted antibody therapies that leverage antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), immunological mechanisms known to eliminate tumor cells. BND-35 reprograms the suppressive TME to a more pro-inflammatory one and reverses the inhibitory effects of ILT3 on ADCC and ADCP mechanisms.

"We are thrilled to partner with Merck KGaA, Darmstadt, Germany to secure the supply of cetuximab for our clinical trial and thank Merck KGaA, Darmstadt, Germany for their interest in BND-35" said Tal Sines, VP of Business Development at Biond Biologics. "Our preclinical data show that BND-35 can synergize with therapies such as cetuximab, that promote ADCC and ADCP activities. It could provide a potential new treatment option for patients with solid tumors.

About BND-35

BND-35, an innovative anti-ILT3/LILRB4 antibody designed to remodel the tumor microenvironment. BND-35 is currently under evaluation as a monotherapy in a Phase 1 clinical trial, which is exploring the safety, tolerability, and potential anti-tumor activity of BND-35 (NCT06274437). BND-35 is being assessed as monotherapy in the BND-35-001 trial, and in combination with established anti-EGFR (cetuximab) and PD-L1 therapies across various indications.

Hoth Therapeutics Announces Update on Cancer Therapeutic HT-KIT Results Suggesting the Treatment Effectively Inhibited Tumor Growth in Preclinical Treatment Study

On October 29, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company dedicated to developing new generation therapies for unmet medical needs, reported highly promising early data from a preclinical study of its latest cancer treatment (Press release, Hoth Therapeutics, OCT 29, 2024, View Source [SID1234647497]). The preliminary results demonstrate that the treatment successfully stabilizes tumor growth with remarkable consistency across subjects, showing potential as an effective therapeutic option in oncology. This study was performed and took place under a sponsored scientific research agreement with NC State University.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study measured tumor volumes in treated and untreated subjects over the course of the experiment. Tumor volume measurements in the treated group exhibited minimal changes, suggesting that the treatment effectively inhibited tumor growth. Additionally, all tumors in the treated animals displayed remarkable consistency in volume, with standard deviation error bars barely visible—a strong indication of the treatment’s uniformity and reproducibility in suppressing tumor growth.

"These early findings are incredibly encouraging and demonstrate that our treatment has the potential to halt tumor progression consistently across subjects," said Robb Knie, CEO of Hoth Therapeutics. "The stability and low variability observed in tumor volumes among treated animals are indicative of a promising therapeutic effect, and we’re excited to move forward with further testing as we process additional tissue data."

Key observations from the initial data include:

Stabilized Tumor Growth: Tumor volumes in treated subjects remained remarkably stable over the course of the study, suggesting that the treatment may significantly inhibit tumor growth.

Consistency Across Subjects: Tumor sizes were highly consistent across all treated animals, as demonstrated by the minimal error bars on the graph. This uniform response highlights the treatment’s potential reproducibility and reliability.

Comparison with Untreated Controls: In contrast, untreated subjects showed greater variability and an increase in tumor volume, underscoring the potential efficacy of the treatment in slowing or halting tumor growth.
As Hoth Therapeutics advances this research, the company will continue analyzing additional tissue data to further validate these results. The company is committed to moving forward with the development of this promising treatment and exploring its full potential for patients in need of effective cancer therapies.

Shorla Oncology Announces U.S. Food and Drug Administration (FDA) Expanded Approval of JYLAMVO™ (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications

On October 29, 2024 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has expanded the approval of JYLAMVO (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) (Press release, Shorla Oncology, OCT 29, 2024, View Source [SID1234647498]). With this approval, JYLAMVO is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills"

"This approval follows JYLAMVO’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases," said Sharon Cunningham, chief executive officer of Shorla Oncology. "We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S. as we continue to develop innovative solutions for those with limited treatment options."

JYLAMVO was first approved by the FDA as the only oral liquid methotrexate to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.

JYLAMVO has an orange flavor and comes with a dedicated dosing syringe.

"For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills," said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology. "At Shorla, we are committed to continuity of supply of age-appropriate formulations for patients in need."

Rayna Herman, chief commercial officer of Shorla Oncology added, "In addition to its palatable formulation, JYLAMVO offers key differences over similar drugs, such as room temperature stability for three months after opening, which eliminates the need for refrigeration before dispensing and adds convenience for patients. We are excited to expand our portfolio of innovative therapies for underserved patient populations."

About JYLAMVO

JYLAMVO is an anti-inflammatory and cancer oral methotrexate solution approved by the U.S. Food and Drug Administration for use in adult and pediatric patients with rheumatological, dermatological and oncological diseases. JYLAMVO is an easy-to-administer, orange flavored solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation. JYLAMVO offers advantages because it remains stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage pre-dispense.

Sensei Biotherapeutics to Present at Two Upcoming Scientific Conferences

On October 29, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that the Company will present at two upcoming scientific conferences (Press release, Sensei Biotherapeutics, OCT 29, 2024, View Source [SID1234647496]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference and Presentation Details:

PEGS Europe: Protein and Antibody Engineering Summit, November 5-7, 2024, Barcelona, Spain

Title: Selectively Targeting VISTA in the Tumor-Microenvironment with SNS-101, a Conditionally Active Monoclonal Antibody
Presenter: Edward van der Horst, Ph.D., Chief Scientific Officer
Session: Antibody-Based Cancer Therapies
Date and time: Tuesday, November 5, 2024, 9:00 a.m. CET (Central European Time)

Society for Immunotherapy Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, November 6-10, Houston Texas

Title: Spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications
Presenter: F. Donelson Smith, Ph.D., Senior Director, Biologics Discovery & Early Development
Presentation Type: Poster
Abstract Number: 70
Date and Time: Saturday, November 9, 2024, 12:15–1:45 p.m. & 7:00-8:30 p.m. CST.
Location: Level 1-Exhibit Halls AB (George R. Brown Convention Center)