CG Invites Co., Ltd.

DUBLIN--( BUSINESS WIRE )--The "Biopharmaceutical Excipients Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering. The Biopharmaceutical Excipients Market was valued at USD 2.43 billion in 2023, and is expected to reach USD 3.79 billion by 2029, rising at a CAGR of 7.69% The global biopharmaceutical excipients market report contains exclusive data on 36 vendors. The market is characterized by diverse vendors, from emerging mid-sized companies to well-established players, contributing to its revenue. Leading companies are employing various strategies to increase their market share and presence. These include launching new products, securing approvals, engaging in marketing and promotional activities, investing heavily in R&D, and strengthening their distribution networks. Major players such as Merck KGaA, BASF SE, Avantor, Evonik Industries, Roquette Freres, Associated British Foods, and others are also focusing on strategic licensing, acquisitions, and collaboration agreements with emerging companies to quickly enter the biopharmaceutical excipients market and access commercially available products. Expanding into existing and new markets to meet the needs of a growing customer base, broadening product portfolios, and enhancing production capabilities are key strategies to attract end-users. Additionally, companies are introducing advanced and novel excipient solutions to support pharmaceutical drug development, ensuring robust distribution chains to meet market demand. APAC shows significant growth, with the fastest-growing region in the global biopharmaceutical excipients market. The APAC region is poised for significant growth, driven by several key factors. The region's expanding pharmaceutical industry, advancements in functional excipients, and the rising use of orphan drugs underscore robust growth prospects. The emergence of multifunctional excipients and the shift of pharmaceutical manufacturing to emerging markets further enhance these prospects. Additionally, the burgeoning biosimilar industry in APAC presents new opportunities for excipients used in biopharmaceutical formulations. The region is witnessing an increasing target patient population, particularly those affected by cancer, which remains the second-highest cause of death globally. MARKET TRENDS & DRIVERS Demand for Novel Excipients in Advancing Biopharmaceutical Development Developing new and improved biopharmaceutical drugs relies on novel excipients essential for advanced product formulations. Unlike conventional excipients, these novel substances have not been used in FDA-approved drug products and lack established food use. Advocates highlight their public health benefits, including enhanced drug delivery and their utility in abuse-deterrent opioid formulations. Recognition by the FDA as novel excipients would assure drug developers of their safety, reducing concerns during application review. While many approved drug excipients are listed in the FDA's Inactive Ingredient Database (IID) and have been used for decades, novel excipients are typically not included in the IID. They may be intended for new administration routes, higher dosages, or modifications like particle engineering. In a significant step towards modernizing drug formulation, the FDA has initiated a program to test the safety and suitability of novel inactive ingredients for new drugs and biologics. This initiative encourages using novel excipients in clinical trials, providing excipient suppliers with a faster route to market and promoting innovative therapies. Increasing Demand for Excipients in Vaccine and Regenerative Medicine Formulations Excipients play a critical role in stabilizing vaccines and developing regenerative medicines, ensuring safety, stability, and efficacy. Vaccines, inherently unstable and prone to degradation, require various excipients like diluents, preservatives, stabilizers, adjuvants, and buffering agents. For instance, preservatives such as formaldehyde prevent contamination, while stabilizers like sucrose and gelatin maintain potency during storage and transport. Aluminum salts are used as adjuvants, enhancing immune response, and buffering agents like sodium chloride maintain pH balance. In regenerative medicine, the demand for novel excipients is rising, driven by the growth in cell and gene therapies to treat rare diseases. These therapies utilize excipients such as buffers, salts, polymers, and proteins to stabilize formulations and ensure physiological osmolality. The investment in cell and gene therapy has surged, necessitating innovative excipients to support the development of advanced therapeutic solutions. Strategic Outsourcing in Biopharmaceutical Excipient Manufacturing Pharmaceutical companies are increasingly outsourcing the manufacturing of biopharmaceutical excipients due to several key factors. Rapid advancements in biopharmaceutical R&D have created a need for specialized excipients that enhance drug efficacy, stability, and delivery, requiring complex and costly manufacturing processes. Outsourcing allows pharmaceutical firms to focus on core activities like drug discovery, clinical trials, and regulatory affairs, leveraging the expertise of specialized manufacturers to streamline operations and accelerate market entry for new therapies. Outsourcing also provides flexibility and scalability, enabling companies to adjust capacity and maintain compliance with evolving regulatory standards, ensuring a reliable supply chain. Additionally, it offers cost-effectiveness by reducing the capital expenditures for in-house manufacturing facilities and allowing more efficient resource allocation while maintaining high-quality standards. The need for innovation, operational efficiency, regulatory compliance, and cost savings drives the trend toward outsourcing. INDUSTRY RESTRAINTS Supply Chain and Integrity Issues with Biopharmaceutical Excipients The integrity and reliability of the biopharmaceutical excipient supply chain are crucial for the quality and efficacy of biopharmaceutical products. This complex global supply chain, involving multiple suppliers and distributors, poses significant challenges. Though pharmacologically inert, excipients require strict management to prevent adulteration and ensure patient safety. The rise of novel excipients and delivery systems amplifies the need for robust quality control, certification, and supply chain management. The extended supply chains and increased importation introduce risks of counterfeit or substandard excipients, potentially causing production delays and adverse effects. Ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards is essential. Historical incidents, such as the 2012 contamination with industrial-grade gelatin, highlight the importance of strict controls. Regulatory bodies like the FDA and China's SFDA have enforced stricter regulations on high-risk excipients. To maintain market growth, pharmaceutical manufacturers must prioritize high-quality excipients, adhering to stringent regulatory requirements despite the complexities of the supply chain. KEY QUESTIONS ANSWERED: How big is the global biopharmaceutical excipients market? What is the growth rate of the global biopharmaceutical excipients market? What are the key trends in the global biopharmaceutical excipients market? Which region shows the highest growth in the global biopharmaceutical excipients market? Who are the major players in the global biopharmaceutical excipients market? Key Attributes: Report Attribute Details No. of Pages 163 Forecast Period 2023 - 2029 Estimated Market Value (USD) in 2023 $2.43 Billion Forecasted Market Value (USD) by 2029 $3.79 Billion Compound Annual Growth Rate 7.6% Regions Covered Global Key Vendors Merck KGaA BASF SE Avantor Evonik Industries AG Roquette Freres Associated British Foods plc Other Prominent Vendors Actylis Advancion Apothecon Pharmaceuticals Ashland BioSpectra BOC Sciences CG Group Clariant Colorcon DFE Pharma Dow Eastman Chemical Company IMCD Innophos InVitria ABITEC CordenPharma Croda International plc JRS Pharma Kirsch Pharma MEGGLE Novo Nordisk Pfanstiehl Shin-Etsu Chemical Sigachi Industries Spectrum Chemical Stepan Company Tereos The Lubrizol Corporation WACKER CHEMI By Excipient Bulking Agents Solubilizers & Surfactants Buffering & Tonicity Agents Others By Biologics Monoclonal Antibodies Vaccines Others By Scale of Operation Commercial Research By Origin Organic Excipients Inorganic Excipients By End-User Pharma & Biotech Companies CMOs & CDMOs Academic & Research Institutes By Geography North America The U.S. Canada Europe Germany The U.K. France Italy Spain APAC Japan China India Australia South Korea Latin America Brazil Mexico Argentina Middle East & Africa Turkey South Africa Saudi Arabia For more information about this report visit https://www.researchandmarkets.com/r/7oy3j7 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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HERZLIYA, Israel and CALGARY, Alberta , July 2, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that it has engaged Past-President of the Eastern Pain Association, Dr. William K. Schmidt, to support its LPT-CBD submission process to the FDA for chronic pain. "We are thrilled to have Dr. Schmidt as part of our LPT-CBD submission expert team," said Iris Bincovich, CEO of Innocan. "His extensive expertise in pain-related clinical development and regulatory affairs will strongly contribute to our LPT-CBD submission process with the FDA. His expertise significantly strengthens our team as we work towards FDA approval." Dr. Schmidt brings over 25 years of pharmaceutical industry clinical trial experience, specializing in analgesic and narcotic antagonist drug development. He has held key positions at several pharmaceutical companies, including CrystalGenomics, Limerick BioPharma, Renovis, Inc., Adolor Corporation, and DuPont Merck. At Adolor, Dr. Schmidt played a crucial role in the development and FDA approval of Entereg® (alvimopan), a peripherally acting opioid antagonist. At CrystalGenomics, Dr. Schmidt led the clinical team that lead to the approval of Acelex® (polmacoxib) in South Korea. At DuPont / DuPont Merck, Dr. Schmidt played key roles in the development of nalbuphine (Nubain®), naltrexone (Trexan®, ReVia®) and the oxycodone-ibuprofen formulation used in Combunox™. Currently, as head of NorthStar Consulting, he advises pharmaceutical and biotech companies globally on pain medicine development. Dr. Schmidt received a BA from the University of California Berkeley, and received his PhD from the University of California San Francisco. About Innocan Pharma: Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Caution Regarding Forward-Looking Information Certain information set forth in this news release, including, without limitation, the Company's plans for human trials of its LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of production and distribution arrangements. Forward-looking information is subject to various risks and uncertainties that could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import/export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner). The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks that impact Innocan can be found in Innocan's public reports and filings which are available under Innocan's profile at . Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law. Logo: Contact Information: For Innocan Pharma Corporation: Iris Bincovich, CEO +1 5162104025 +972-54-3012842 +442037699377 [email protected] SOURCE Innocan Pharma Corporation

ORINDA, Calif., May 29, 2024 /PRNewswire/ -- CG Pharmaceuticals, a company dedicated to advancing innovative therapies to improve the lives of patients with cancer, prepares to showcase its advancements in metastatic PDAC therapy. The study design of a randomized multi-center Phase 2 US clinical trial, which is actively enrolling patients, is scheduled to be presented on June 1st, 1:30 – 4:30 PM CDT at the ASCO Annual Meeting (ClinicalTrials.gov NCT05249101). "Metastatic PDAC continues to be an aggressive cancer with limited treatment options. We are pleased that CG Pharmaceuticals is investing in pancreatic cancer research and look forward to the results of their trial," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at the Pancreatic Cancer Action Network (PanCAN). "Clinical trials are an important aspect of accelerating new developments that improve outcomes for pancreatic cancer patients. PanCAN recommends that patients with PDAC consider participating in clinical trials." In the Phase 1b study, 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at three dose levels (60, 125, and 250 mg/m²) in combination with capecitabine. The study demonstrated a favorable safety profile, with no treatment-related serious adverse events. At the time of data cutoff (5/6/2024), 16 patients were alive with 3 patients continuing treatment, and 7 patients were treated for longer than 6 months with the longest duration of treatment of 16 months. The Phase 2 study compares the efficacy of ivaltinostat/capecitabine combination therapy versus capecitabine monotherapy in metastatic PDAC patients who have shown no evidence of disease progression after first-line chemotherapy. Efficacy endpoints include progression-free survival, objective response rate, disease control rate, and overall survival. About Ivaltinostat: Ivaltinostat is a potential first-in-class novel therapeutic candidate for PDAC that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies. CG Pharmaceuticals continues to make strides in its mission to provide innovative treatment options for metastatic PDAC patients. Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them. No forward-looking statements can be guaranteed, and actual results may differ. CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. CG Pharmaceuticals Contact: Douglas An Head of Finance and IR Representative [email protected] SOURCE CG Pharmaceuticals, Inc.