SAN FRANCISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) ...

Core Viewpoint - Innovent Biologics reported strong commercial performance and significant pipeline milestones in the first half of 2024, indicating sustained growth and innovation in its operations [2][3]. Financial Performance - Total revenue reached RMB3,952.3 million, reflecting a year-over-year growth of 46.3% [3]. - EBITDA loss was reduced to RMB160.8 million, a notable year-over-year decrease of 39.9% [3]. - Gross profit margin improved to 84.1%, up by 1.8 percentage points year-over-year [3]. - Selling and marketing expenses decreased to 48.6%, down by 5.9 percentage points year-over-year [3]. - R&D expenses totaled RMB1,293.9 million, with cash and short-term financial assets amounting to RMB10,112.3 million (over USD1.4 billion) [3]. Product Revenue Growth - Product sales revenue was RMB3,811.4 million, showing a strong year-over-year growth of 55.1% [4]. - The company has eleven approved products, including TYVYT® and BYVASDA®, with new approvals in the Macau market [4]. - TYVYT® and BYVASDA® were included in the National Reimbursement Drug List (NRDL) for treating EGFR-mutated NSCLC [4][12]. Pipeline and Innovation - Seven new assets are in NDA review or pivotal registrational clinical trials, with 18 assets in early-phase clinical studies [6]. - Significant progress in late-stage assets, including new indications for TYVYT® and IBI310 [6]. - The company is actively preparing for commercialization in the cardiovascular and metabolic (CVM) field, with three new drug applications submitted [5]. Manufacturing and R&D Capacity - A new R&D center in Shanghai became operational in August 2024, enhancing research capabilities [7]. - The first manufacturing site has a production capacity of 60,000L for antibodies and ADCs, with a second site under construction [7]. ESG Commitment - Innovent is committed to sustainable development and ethical business practices, recently launching an ESG website to highlight its initiatives [7]. - The company received an 'A' level in MSCI ESG rating, positioning it at the forefront of the biotechnology industry [7].

Financial Performance - For the six months ended June 30, 2024, total revenue was RMB 3,952.3 million, an increase of 46.3% compared to RMB 2,701.5 million for the same period in 2023[3]. - Product revenue for the same period was RMB 3,811.4 million, representing a growth of 55.1% from RMB 2,457.5 million in the prior year[3]. - Gross profit for the six months ended June 30, 2024, was RMB 3,274.7 million, compared to RMB 2,196.9 million in the same period of 2023, representing a growth of 49%[40]. - The company reported a pre-tax loss of RMB 392.6 million for the six months ended June 30, 2024, compared to a loss of RMB 256.1 million in the same period of 2023[40]. - The net loss for the period was RMB 392.6 million, an increase of RMB 253.5 million from RMB 139.1 million in the prior year[3]. - The company’s basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.24, compared to RMB 0.09 in the same period of 2023[72]. - Other income increased to RMB 300.6 million for the six months ended June 30, 2024, from RMB 232.4 million in the same period of 2023, marking a rise of 29.3%[44]. Research and Development - Research and development expenses increased to RMB 1,399.4 million, compared to RMB 922.8 million in the same period last year[3]. - The company delivered six molecules into clinical research for new drug applications (IND) during the reporting period, enhancing global innovation and sustainable growth[9]. - IBI362 has five ongoing Phase 3 clinical trials, with GLORY-1 and DREAMS-1 achieving study endpoints to support its NDAs[7]. - The company is focused on developing innovative therapies for chronic diseases, with IBI3016 (AGT siRNA) entering Phase 1 clinical trials for hypertension[19]. - The company is actively expanding its pipeline with next-generation innovations, including bispecific antibodies and ADCs, targeting unmet needs in oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology[36]. Product Development and Approvals - The company expanded its commercial product portfolio to 11 products, including the approval of the KRAS G12C inhibitor Daberet® for treating advanced NSCLC patients with KRAS G12C mutations[6]. - The NDA for IBI311 (anti-IGF-1R monoclonal antibody) was submitted and accepted by NMPA in May 2024, addressing a significant unmet need in the TED field in China[17]. - The NDA for IBI344 (Tazemetostat) was accepted by NMPA for patients with locally advanced or metastatic ROS1-positive NSCLC, with approval expected in 2024[29]. - IBI343, a novel CLDN18.2 antibody-drug conjugate, showed positive Phase 1 clinical results for gastric cancer treatment and received breakthrough therapy designation from NMPA[8]. - The company aims to expand its product portfolio to 12 by the end of 2024, including two targeted therapies for NSCLC expected to be approved in the second half of the year[12]. Marketing and Sales - Sales and marketing expenses were RMB 1,879.4 million, accounting for 47.6% of total revenue, down from 49.9% in the previous year[3]. - The company is enhancing its marketing output and operational efficiency through resource allocation and effective management methods[13]. - The company is committed to creating sustainable shareholder value through its strong commercialization and R&D capabilities, as well as a promising late-stage pipeline[20]. Corporate Governance and Compliance - The company has complied with all applicable provisions of the Corporate Governance Code, except for the separation of the roles of Chairman and CEO, which are currently held by the same individual[63]. - The company established a strategic clinical trial collaboration with ImmVirX Pty Limited to evaluate the combination therapy of its drug with ImmVirX's experimental oncolytic virus[39]. - The company will continue to review and monitor its corporate governance practices to ensure compliance and maintain high standards[63]. Financial Position and Assets - As of June 30, 2024, the company had cash and cash equivalents, structured products, and other financial assets totaling approximately RMB 10.112 billion[14]. - Total current assets as of June 30, 2024, were RMB 13,427.9 million, an increase from RMB 11,048.7 million as of December 31, 2023[54]. - Total liabilities as of June 30, 2024, were RMB 8,099.8 million, compared to RMB 7,869.3 million as of December 31, 2023[54]. - The company had unused long-term bank loan facilities of approximately RMB 2,080.5 million as of June 30, 2024[55]. Employee and Operational Metrics - As of June 30, 2024, the company had a total of 5,263 employees, an increase from 4,872 employees as of December 31, 2023, with over 1,000 in R&D and over 3,000 in sales and marketing[61]. - The total salary cost for the six months ended June 30, 2024, was RMB 1,391.6 million, compared to RMB 1,358.8 million for the same period in 2023, reflecting an increase of approximately 2.4%[61]. - There were no significant labor disputes or recruitment difficulties encountered by the company during the reporting period[61].

Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for Dupert® (fulzerasib), the first KRAS G12C inhibitor in China, aimed at treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have undergone at least one systemic therapy [1][2] - The approval is based on a Phase 2 clinical study showing a confirmed objective response rate (ORR) of 49.1% and a disease control rate (DCR) of 90.5% among 116 evaluable NSCLC subjects [1][2] - Innovent has launched a total of 11 products and continues to expand its oncology portfolio, with Dupert® marking a significant advancement in targeted therapy for KRAS mutations [1][3] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, cardiovascular, metabolic, autoimmune, and ophthalmic conditions [3] - The company has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials, and 18 molecules in early clinical stages [3] - Innovent collaborates with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [3] Product Details - Fulzerasib is designed to target the KRAS G12C mutation, which is prevalent in various cancers, including 15-20% of lung cancer cases [2] - The drug has shown promising preclinical results, demonstrating high selectivity towards the G12C mutation and effectively inhibiting downstream signaling pathways to induce tumor cell apoptosis [2] - The approval process for fulzerasib included Breakthrough Therapy Designation (BTD) from the NMPA for both advanced NSCLC and colorectal cancer patients with KRAS G12C mutations [2]

Investment Rating - The investment rating for the company is "Buy (Maintain)" [6] Core Insights - The company is a rare platform-type innovative drug enterprise in China, possessing top-tier capabilities in early drug discovery, clinical development, manufacturing, and commercialization. The rich pipeline of innovative drugs and the stable cash flow from 10 already marketed products provide a solid foundation for growth. Upcoming products like Masitide and Pikanqi monoclonal antibody have submitted applications for market approval, offering a second growth curve. Early pipelines such as PD-1/IL-2 bispecific antibodies show best-in-class potential and are expected to lead to significant overseas licensing deals [9][13][51]. Summary by Sections Company Overview - The company has transformed from an innovative biotech firm to a leading biopharmaceutical company in China, focusing on developing, manufacturing, and selling innovative drugs for major diseases such as cancer, metabolic disorders, autoimmune diseases, and ophthalmology. As of December 31, 2023, the company has approximately 6,000 employees and 26 clinical pipelines, with 10 innovative drug products already commercialized [20]. Market Potential - The market for anti-tumor drugs is rapidly growing, driven by an increasing number of cancer patients and unmet clinical needs. In 2022, there were 4.8247 million new cancer cases in China, and the anti-tumor drug market is projected to reach 586.6 billion yuan by 2030, with a CAGR of 12.4%. The obesity market is also expanding, with the obesity rate expected to rise from 50.7% in 2020 to 65.3% by 2035, leading to significant medical expenditures [10][37][40]. Product Pipeline and Commercialization - The company achieved product sales revenue of 5.728 billion yuan in 2023, a year-on-year increase of 38.4%. It has four new indications approved and four new drug applications submitted, with ten products entering Phase III or critical clinical stages. The company aims to commercialize about 20 innovative drug products by 2027, targeting annual domestic sales of 20 billion yuan [10][11][16]. Financial Forecast and Valuation - Revenue forecasts for 2024-2026 are 7.8444 billion yuan, 10.1333 billion yuan, and 13.2353 billion yuan, with year-on-year growth rates of 26.4%, 29.2%, and 30.6%, respectively. The net profit attributable to the parent company is expected to be -533.16 million yuan, 251.58 million yuan, and 1.33381 billion yuan, with growth rates of 48.13%, 147.19%, and 430.17% [11][15]. Competitive Advantages - The company has established a comprehensive and integrated technology platform for drug development, with a strong focus on R&D investment. The R&D expenses increased from 1.222 billion yuan in 2018 to 2.228 billion yuan in 2023, and the R&D team expanded from 492 to nearly 1,500 members [24][25]. The company has also formed strategic partnerships with major international pharmaceutical companies, enhancing its development capabilities [30]. Conclusion - The company is well-positioned for sustained growth due to its innovative drug pipeline, strong market potential in oncology and obesity, and robust financial forecasts. The ongoing commercialization of new products and the potential for significant licensing deals further enhance its investment appeal [9][10][11][51].

Investment Rating - Buy rating, first coverage [5] Core Views - The company is a leading domestic Biopharma player with validated commercialization capabilities, transitioning from Biotech to Biopharma [2] - The company is expanding its innovative drug business from oncology to non-oncology fields, including autoimmune, metabolic, and ophthalmic diseases [2] - In oncology, the company is enriching its late-stage pipeline through self-development and BD collaborations, building an "I/O+ADC" product cluster [2] - Multiple oncology pipeline products are expected to release early PoC data in 2024, further validating the company's R&D capabilities [2] - The company has several non-oncology products in late-stage clinical trials or NDA review, which are expected to provide new growth drivers in the long term [2] Company Overview - Founded in 2011, the company focuses on the R&D, production, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmic diseases [3] - The company has over 30 innovative drug candidates, with 10 products already commercialized, 4 under NDA review, and 4 in Phase III or key clinical trials [3] - In 2023, the company achieved total revenue of RMB 6.206 billion (+36.2% YoY), with product revenue of RMB 5.728 billion (+38.4% YoY) [3] - The core product, Sintilimab (PD-1 monoclonal antibody), generated sales of USD 393 million in 2023 [3] Oncology Pipeline - The company's oncology strategy revolves around "I/O+ADC," with Sintilimab as the anchor product, approved for seven indications across five major cancer types [3] - The company is enriching its late-stage oncology pipeline through BD collaborations, such as the KRAS G12C inhibitor fulzerasib and the ROS1 inhibitor taletrectinib, both of which have submitted NDAs [3] - The company is actively building ADC and bispecific antibody/fusion protein technology platforms, with several PoC products entering clinical trials [3] - Early clinical data for self-developed products such as IBI343 (Claudin18.2 ADC), IBI389 (Claudin18.2/CD3 bispecific antibody), and IBI363 (PD-1/IL-2) were presented at ASCO and ESMO 2024, showing promising potential [3] Non-Oncology Pipeline - The company is strategically expanding into non-oncology fields, including metabolic, autoimmune, and ophthalmic diseases, which are expected to become new growth drivers [4] - IBI362, a next-generation GLP-1/GCGR dual-target drug, is the fastest progressing domestic weight-loss drug, with an NDA submitted in February 2024 for the treatment of adult overweight or obesity [4] - Tafolecimab, the first domestically developed PCSK9 monoclonal antibody, has shown stronger affinity and longer dosing intervals compared to competitors [4] - IBI112, targeting psoriasis, is expected to become the first domestic IL-23p19 monoclonal antibody, with global sales of its counterparts exceeding USD 10 billion in 2023 [4] - IBI311, targeting thyroid eye disease, has submitted the first domestic NDA for the IGF-1R target, with Tepezza generating USD 1.966 billion in global sales in 2022 [4] Financial Projections - The company is expected to achieve revenues of RMB 7.929 billion, RMB 10.567 billion, and RMB 13.167 billion in 2024, 2025, and 2026, respectively [6] - Net profit is projected to be -RMB 573 million, RMB 364 million, and RMB 1.368 billion in 2024, 2025, and 2026, respectively [6] - EPS is expected to be -RMB 0.35, RMB 0.22, and RMB 0.84 in 2024, 2025, and 2026, respectively [6] Leadership and Shareholding - The company's leadership team has deep industry and academic backgrounds, with founder Dr. Yu Dechao holding 5.42% of the shares [12] - Temasek is the largest shareholder with a 5.52% stake, followed by The Capital Group with 6.06% [12] Commercialization and R&D - The company has 10 commercialized products, with Sintilimab sales rebounding to USD 393 million in 2023 after a decline in 2022 due to price reductions after inclusion in the national reimbursement list [15] - The company's R&D expenses have increased from RMB 1.295 billion in 2019 to RMB 2.871 billion in 2022, with over 1,500 R&D personnel [21] - The company's R&D focus includes FIC and BIC drugs in oncology, autoimmune diseases, and ophthalmology [21]

SAN FRANCISCO and SUZHOU, China, July 25, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced a strategic partnership with WeComput to jointly advance the construction and improvement of Innovent Biologics' Artificial Intelligence for Drug Discovery pla ...

Core Insights - Innovent Biologics announced that the Phase 3 clinical trial (DREAMS-1) of mazdutide for type 2 diabetes (T2D) met its primary and key secondary endpoints, demonstrating significant efficacy in glycemic control and weight loss [1][3][6] - The company plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) soon, following the acceptance of its first NDA for chronic weight management in February 2024 [1][10] Clinical Trial Results - DREAMS-1 was a randomized, double-blind, placebo-controlled trial involving 320 participants, showing a reduction in HbA1c of 1.57% for the 4 mg group and 2.15% for the 6 mg group compared to 0.14% for placebo at week 24 [2][3] - Key secondary endpoints indicated that mazdutide led to a higher proportion of patients achieving HbA1c < 7.0% and weight reduction ≥ 5% compared to placebo [3][4] Safety and Tolerability - The safety profile of mazdutide was favorable, with gastrointestinal adverse events being the most common, mostly mild to moderate, and no new safety signals identified [5][6] - The incidence of hypoglycemia was low, with no severe cases reported [5] Broader Implications - The results of the DREAMS-1 study provide significant medical evidence supporting the use of next-generation multi-target GLP-1R/GCGR drugs for T2D treatment, addressing the urgent need for innovative medications in China, where over 140 million people live with diabetes [7][8] - Mazdutide is positioned as a dual agonist that not only lowers blood glucose but also offers multiple cardiometabolic benefits, including weight loss and improved metabolic indicators [4][9] Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, with 10 products currently on the market and several new drug applications under review [11]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 51.05 [5][14]. Core Insights - The company has shown significant clinical data for its drug Mazdutide, which is expected to be approved in the first half of 2025, slightly ahead of previous expectations [2]. - The company has adjusted its revenue and profit forecasts for 2025 and 2026 upwards due to the anticipated earlier launch of Mazdutide and improved clinical results [3]. - The company reported a substantial increase in product sales revenue, with a year-on-year growth of 60% in the first quarter [3]. Financial Summary - Total revenue is projected to grow from RMB 6,206 million in 2023 to RMB 11,845 million by 2026, reflecting a compound annual growth rate (CAGR) of 18.5% [11]. - Shareholder net profit is expected to turn positive by 2025, with a forecasted profit of RMB 182 million in 2025 and RMB 367 million in 2026 [11]. - The company’s earnings per share (EPS) is projected to improve from a loss of RMB 0.66 in 2023 to a profit of RMB 0.24 by 2026 [11]. Adjustments to Forecasts - Revenue forecasts for 2025 and 2026 have been increased by 1.0% and 4.9%, respectively, due to the positive outlook for Mazdutide [3][6]. - The sales expense ratio for 2026 has been revised down from 38.7% to 37.9%, reflecting the company's confidence in managing costs amid high demand for GLP-1 drugs [3]. Clinical Data Highlights - In clinical trials, Mazdutide demonstrated a weight reduction of 13.38% and 14.84% after 32 and 48 weeks, respectively, and an 80.2% reduction in liver fat content after 48 weeks [2][6]. - The drug also showed significant improvements in waist circumference, blood pressure, and lipid levels, indicating a reduced risk of cardiovascular diseases [2][9].

Investment Rating - The report assigns an "Accumulate" rating to the company, indicating a positive outlook for its stock performance relative to the local market index [4][21]. Core Views - The report highlights the promising clinical data from the company's pipeline, particularly in the oncology sector, and anticipates significant market potential for the drug Masitide [4][5]. - The company is expected to receive approval for Masitide in the first half of 2025, which is projected to enhance its market presence and sales [5]. - The report emphasizes the company's strong positioning in the IO+ADC (Immuno-Oncology and Antibody-Drug Conjugates) space, with encouraging clinical results that suggest a robust commercial value for its oncology pipeline [5]. Financial Summary - Revenue projections show a steady increase from 4,270 million RMB in 2021 to an estimated 13,284 million RMB by 2026, reflecting a compound annual growth rate (CAGR) of approximately 35% [4]. - The net loss is expected to narrow significantly, from -3,138 million RMB in 2021 to a profit of 1,646 million RMB by 2026, indicating a turnaround in profitability [4]. - The price-to-earnings (PE) ratio is projected to improve from -20.55 in 2021 to 35.54 by 2026, suggesting a more favorable valuation as the company moves towards profitability [4].