Bushu Pharmaceuticals Ltd.

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Cytotoxic Drugs and HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies, Europe, Asia-Pacific and Rest of the World: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering. "Cytotoxic Drugs and HPAPI Manufacturing Market 2022-2035" report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth. Frequently Asked Questions What are the current opportunities within the HPAPI and cytotoxic drug market? The cytotoxic drugs and HPAPI manufacturing market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain? The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain? Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment. What are the key challenges faced by HPAPI and cytotoxic drug CMOs? The primary challenge faced during the manufacturing of highly potent APIs and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds. What are the key value drivers in the HPAPIs and cytotoxic drugs contract manufacturing market? The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players. How is the revenue generation potential associated with cytotoxic drugs and HPAPI manufacturing market likely to evolve in the coming years? The cytotoxic drugs and HPAPI manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term. The report features detailed transcripts of interviews held with the following individuals: Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals) Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent) Roberto Margarita (Business Development Director, CordenPharma) Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics) Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research) Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare) Allison Vavala (Ex-Senior Manager, Business Development, Helsinn) Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) Javier E. Aznarez Araiz (Ex-Business Development, Idifarma) COMPANY COMPETITIVENESS ANALYSIS HPAPI Contract Manufacturers: Company Competitiveness Analysis Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA AbbVie Cambrex Catalent Pfizer CentreOne Piramal Pharma Solutions COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE Abzena Aenova CARBOGEN AMCIS Hovione Lonza COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF THE WORLD Intas Pharmaceuticals Scinopharm STA Pharmaceutical (a WuXi AppTec company) Syngene Teva API LIST OF COMPANIES AND ORGANIZATIONS AbbVie Abzena ACES Pharma Adare Pharma Solutions ADC Biotechnology ADC Therapeutics ADIENNE Pharma and Biotech Aenova AGC Pharma Chemicals (A subsidiary of AGC Group) Agno Pharma AIMEDBIO Ajinomoto Bio-Pharma Services ALB Technology Alcami Alkermes Almac Alphora Research Altasciences Alvogen Amneal Pharmaceuticals AMPAC Fine Chemicals (A SK pharmteco company) Angelini Fine Chemicals (A subsidiary of Angelini Pharma) ANI Pharmaceuticals Antengene ANVI Pharma Aptuit (An Evotec company) Ardena Arevipharma (Acquired by Yonsung Group) Aspen API Astellas Pharma Astorg AstraZeneca Asymchem Laboratories Aurigene Pharmaceutical Services Avra Laboratories (Acquired by Advent International) Baxter BioPharma Solutions Bio-Synthesis BioTechnique BioVectra BiVictriX Therapeutics BOC Sciences Boehringer Ingelheim Bolt Biotherapeutics Boryung Pharmaceutical Bright Peak Therapeutics Bristol Myers Squibb BrYet Health Bryllan BSP Pharmaceuticals Bushu Pharmaceuticals Byondis Cambrex Capsugel (A Lonza company) CARBOGEN AMCIS (A Dishman Carbogen Amcis Group company) Catalent CellMosaic Celon Laboratories Cerbios-Pharma ChemCon ChemPartner CordenPharma CoreRx Creative Biolabs CritiTech Curia Custom Pharmaceutical Services (A part of Dr. Reddy's Laboratories) Cytopharma Daiichi Sankyo Dalton Pharma Services Dipharma Divi's Laboratories DOTTIKON EXCLUSIVE SYNTHESIS EirGen Pharma (Acquired by OPKO Health) Eisai Eli Lilly Enteris BioPharma (A subsidiary of SWK Holdings) Esteve Eurofins Scientific EVER Pharma Excella (Acquired by Fareva) Exelixis Fabbrica Italiana Sintetici Fareva Farmabios (A PharmaZell Group company) Farmhispania Femtogenix Fermion (A subsidiary of Orion) Flamma Formex (A subsidiary of Biotech Investment Group (BIG)) Formosa Laboratories Fresenius Kabi Frontida BioPharm (Acquired by Adare Pharma Solutions) Fujimoto Chemicals GeneQuantum Healthcare Genmab GENTEC PHARMACEUTICAL GROUP Gilead Sciences Glycotope Goodwin Biotechnology GP Pharm GTP Bioways Gustave Roussy Helsinn Advanced Synthesis Heraeus Hovione ICROM Idifarma (Acquired by Ardena) IDT Australia Iksuda Therapeutics ImmunoGen Indena Ind-Swift Laboratories Intas Pharmaceuticals Janssen Biotech Kodiak Sciences Kohlberg Kyongbo Pharmaceutical (A subsidiary of Chong Kun Dang Pharmaceutical) LakePharma Laurus Synthesis LegoChem Biosciences Levena Biopharma (A subsidiary of Sorrento Therapeutics) Lonza Lotus Pharmaceuticals Lubrizol Life Science MabPlex Mac-Chem (A NMS Group Company) Magle Chemoswed Malladi Drugs & Pharmaceuticals Mayne Pharma McSAF MEDICHEM Merck Mersana Therapeutics Metrics Contract Services MilliporeSigma Minafin Minakem (A subsidiary of Minafin) Mitsubishi Tanabe Pharma Mubadala MuseChem Natco Pharma Navrogen NBE-Therapeutics NerPharMa NJ Bio Normon Novartis Novasep Oasmia Pharmaceutical OEP Pharma Olon Oncotec Pharma Produktion Oxford BioTherapeutics Parabolic Drugs Patheon (Acquired by Thermo Fischer Scientific) PCI Pharma Services Pensatech Pharma Pfanstiehl Pfizer Pfizer CentreOne Pharmacare Premium Pharmaceutics International Pharmascience PharmaZell PILA PHARMA Piramal Pharma Solutions PrasFarma Procos (A subsidiary of CBC) ProJect Pharmaceutics Pyxis Oncology Quadira Biosciences Quotient Sciences Recipharm Recro Pharma Regis Technologies RemeGen Richman Chemical SafeBridge Consultants (Acquired by Trinity Consultants) Sai Life Sciences Sanofi Sartorius ScinoPharm Taiwan Seagen Seattle Genetics SEQENS (Acquired by SK Capital Partners) Shionogi Pharma Siegfried Sigma-Aldrich Fine Chemicals (SAFC) (a Sigma-Aldrich company) SK biotek SK Capital Societal CDMO Sofpromed Somatek SOTIO Biotech STA Pharmaceutical (A WuXi AppTec company) Stason Pharmaceuticals Sterling Pharma Solutions Sutro Biopharma Swedish Orphan Biovitrum (SOBI) SWK Holdings Symbiosis Pharmaceutical Services Synaffix Synbias Pharma Syngene Synthon TBD-Biodiscovery Tergus Pharma Teva API TRIO Pharmaceuticals Tubulis University of Goettingen UPM Pharmaceuticals Vectura Veranova VERAXA Biotech VUAB Pharma (A SAFICHEM company) VxP Pharma Wavelength Pharmaceuticals (A subsidiary of SEQENS) WuXi Biologics ZNZ Pharma For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

PictureDesignSwiss / Shutterstock Full data presented Tuesday afternoon from the Phase III Clarity AD trial show Eisai and Biogen's lecanemab has a favorable safety pro patients with Alzheimer's disease. The presentation at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference comes amid mounting concerns about lecanemab's safety. In October, an unnamed Clarity AD investigator linked a patient's death to lecanemab. Now, a second death reported Monday is also being attributed to the investigational drug by an external expert. Both deaths were due to bleeding in the brain. During the CTAD session, Marwan Sabbagh, M.D., a behavioral neurologist at the Barrow Neurological Institute, said that in the randomized, placebo-controlled analysis, "there were no ARIA-related deaths." ARIA, or amyloid-related imaging abnormalities, are physiological anomalies in the brain detected by magnetic resonance imaging, often attributed to amyloid-modifying therapies. Causes of death in the lecanemab arm included cerebrovascular accident, myocardial infarction, respiratory failure, metastases to meninges and COVID-19. Nevertheless, Sabbagh conceded that two deaths were associated with cerebral microhemorrhages in the open-label extension phase of the study. One of these deaths occurred in the context of a tissue plasminogen activator, which Sabbagh said is thrombolytic with a known potential complication risk of hemorrhage. The second patient who died was on medication for atrial fibrillation, had had pneumonia and previously experienced many falls. "These cases show that the causality with lecanemab is a little difficult" to establish, Sabbagh said. Whether treatment with the investigational antibody and deaths are indeed causally related remains under investigation. ARIA suggestive of edema (ARIA-E) occurred in 12.6% of lecanemab-treated patients, as opposed to only 1.7% of the placebo arm. Nevertheless, most ARIA-E events were mild-to-moderate in severity, with 78% of such episodes being asymptomatic. Twenty-five lecanemab recipients had symptomatic ARIA-E, which typically manifested as confusion, headache and visual disturbances. Most ARIA-E episodes occurred within six months of treatment and generally resolved within four months of detection. "We know when the ARIA-E events are likely to occur and when they are likely to resolve," Sabbagh said. Questions About Clinical Meaningfulness Remain Tuesday's presentation follows an earlier efficacy readout in September, which showed lecanemab was indeed effective at slowing cognitive decline in Alzheimer's disease patients. These data, confirmed at CTAD, indicate that lecanemab slowed clinical decline by 27% as compared with placebo, as measured by the Clinical Dementia Rating scale Sum of Boxes (CDR-SB). Lecanemab also outperformed placebo on all key secondary endpoints. For instance, at 18 months, the drug candidate slowed cognitive decline by 26%, as measured by the ADAS-Cog14 scale, and disease progression by 24%, as assessed by the ADCOMS tool. Biomarker analysis also revealed that lecanemab treatment reduced amyloid levels in the patients' plasma and cerebrospinal fluid. Positron emission tomography likewise showed that at 18 months, amyloid levels had dropped below the positivity threshold. As its primary metric for lecanemab efficacy, Clarity AD used CDR-SB, a validated scale used in many Alzheimer's trials. The CDR-SB score is obtained through interviews with patients and their care partners and evaluates cognition across six domains: memory, orientation, personal care, home and hobbies, community affairs and judgment and problem-solving. While these domains have been established as important and relevant for the patients and caregivers, a New England Journal of Medicine article published Tuesday, along with the CTAD presentation, reported that "a definition of clinically meaningful effects in the primary endpoint of the CDR-SB score has not been established." Despite meeting its predefined treatment target, Clarity AD needs to be followed up with longer trials "to determine the efficacy and safety of lecanemab in early Alzheimer's," the authors of the NEJM article recommended.

The Gateway to Asia initiative ensures quality and timely delivery through shorter lead times, temperature and humidity control, and streamlined urgent order processing SAN ANTONIO, July 27, 2022 /PRNewswire/ -- Based on its recent analysis of the pharmaceutical supply chain contract services industry, Frost & Sullivan recognizes Bushu Pharma with the 2022 Japan Customer Value Leadership Award. Bushu Pharma, the premier CDMO in Japan, offers pharmaceutical manufacturing and supply chain management (SCM) solutions, delivering pharmaceutical drug products, specializing in oral solid dosage and parenteral contract manufacturing, supporting clinical trial drug products, and commercial goods, along with packaging according to current Good Manufacturing Practice (GMP) standards. It has established a flexible operational structure capable of handling all SCM functions from import/export to manufacturing on a 24-hour basis. The company mainly caters to pharmaceutical organizations focusing on emerging rare diseases in Asia, especially those without a Japanese subsidiary or limited resources in Japan. Bushu Pharma works closely with its partners to help organizations successfully launch their products, even with minimal resources. It recently partnered with Suzuken, a Japan-grown specialty pharmaceutical distribution firm, to maximize support for new product launches by specialty pharmaceutical manufacturers seeking to enter Japan's market. The partnership establishes a one-stop center for manufacturing operations and general logistics in Soka City, Saitama Prefecture, and uses Suzuken's drug traceability system named Cubixx, to deliver efficient and high-quality products to patients. Cubixx strictly monitors and controls the temperature of specialty drugs, providing an environment for medical professionals to offer medicines safely and securely without compromising quality and risking the patient. "Bushu Pharma has made its mark in the Japan pharmaceutical supply chain contract services market with its expertise spanning well over two decades. With a track record of exporting drugs to more than 43 countries, the company holds global GMP certifications," said Azza Fazar, Best Practices Research Analyst for Frost & Sullivan. Through setting up and utilizing the Kazo Pharmaceutical Joint Logistics Center's cold storage area of more than a thousand square meters, Bushu Pharma offers contract manufacturing focused on secondary packaging services, such as inspection and labeling. The company has gained substantial industry and operation know-how through its offerings and track record, making it highly sought-after by potential clients and recognized as a business's essential differentiator resulting in considerable growth. It develops its account management strategy and proposes improvement initiatives based on client feedback and evaluations to ensure high-standard customer service, which is the core to their business mission and delivery. The company listens to clients through personalized project teams and subject matter experts, establishing trust and long-lasting relationships. Bushu Pharma also enables flexible operations and responds to demands with short lead times through a systemic pharmaceutical supply chain in Asia-Pacific that does not rely on direct imports from Europe, thereby reducing the complexity of supply chain throughout Asia. "Bushu Pharma launched Gateway to Asia in 2021 as an initiative and a value-added offering for international pharmaceutical companies to import bulk products, into Japan for quality inspection, labeling, packaging, and distribution throughout Japan and Asia-Pacific. It eliminates delivery delays, compromised drug environments, and long lead times," as noted by Surbhi Gupta, Senior Industry Analyst for Frost & Sullivan. Customer-centric approaches, revolutionary contract services offerings, and exceptional supply chain strategies underpin Bushu Pharma's impressive growth momentum and trajectory, earning clients' trust and loyalty and more market share. The company's high client satisfaction rate, unsurpassed quality maintenance, and continuous improvement enable customer acquisition through word of mouth and offer immense value to existing and new customers, solidifying its reputation in the market. With its strong overall performance, Bushu Pharma earns Frost & Sullivan's 2022 Japan Customer Value Leadership Award in the pharmaceutical supply chain contract services industry. Each year, Frost & Sullivan presents this award to the company that demonstrates excellence in implementing strategies that proactively create value for its customers with a focus on improving the return on the investment that customers make in its services or products. The award recognizes the company's unique focus on augmenting the value that its customers receive, beyond simply good customer service, leading to improved customer retention and customer base expansion. Frost & Sullivan Best Practices award recognizes companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact: Kala Mani. S. P: +603.2023.2037 E: [email protected] About Bushu Pharma Bushu Pharma was established in August 1998 as an independent pharmaceutical contract manufacturer. Bushu Pharma, capitalized at 1 billion yen, carries out pharmaceutical drug product contract manufacturing and packaging of clinical trials and commercial products in accordance with the latest cGMP standards. Through the utilization of know-how and the latest industry information, Bushu Pharma prides itself in being able to offer added-value solutions to customers. For more information, visit . Contact: Hideyuki Tanaka, Deputy General Manager, Marketing Division P: +81 49 273 6386 E: [email protected] SOURCE Frost & Sullivan