List of Contract Manufacturing Companies with Phase 3 Active Clinical Trial - 18

Agenus Inc., a clinical-stage immuno-oncology company, discovers, manufactures, and develops immuno-oncology products in the United States and internationally. The company offers Retrocyte Display, an antibody discovery platform for the identification of fully-human and humanized monoclonal antibodies; and display technologies. It develops vaccine programs, including Prophage vaccine candidate; AutoSynVax, a synthetic neo-antigen; PhosPhoSynVax, a vaccine candidate designed to induce immunity against a class of tumor specific neo-epitopes; and QS-21 Stimulon adjuvant, a saponin-based vaccine adjuvant. The company also develops CTLA-4 and PD-1 antagonists which is in clinical trial phase I for the dose escalation study; AGEN2373, an anti-CD137 monospecific antibody which is in Phase 1 clinical trial; AGEN1223, a novel bispecific antibody designed to deplete regulatory T cells which is in a Phase 1 clinical trial; GS-1423, a tumor microenvironment conditioning anti-CD73/TGFS TRAP bi-functional antibody which is in Phase 1 clinical trial; and TIGIT antibodies. In addition, it engages in the development of INCAGN1876, an anti-GITR monospecific antibody; INCAGN1949, an anti-OX40 monospecific antibody; INCAGN2390, an anti-TIM-3 monospecific antibody; INCAGN2385, an anti-LAG-3 monospecific antibody; and MK-4830, a monospecific antibody targeting ILT4. Agenus Inc. has collaboration agreements with Incyte Corporation, Merck Sharpe & Dohme, and Recepta Biopharma SA.; and collaboration with Gilead Sciences, Inc. to develop immuno-oncology therapies. The company was formerly known as Antigenics Inc. and changed its name to Agenus Inc. in January 2011. Agenus Inc. was founded in 1994 and is headquartered in Lexington, Massachusetts.

CinnaGen is an Iranian biotechnology company founded in 1994 and headquartered in Tehran. It is recognized as a leading biopharmaceutical manufacturer and exporter in the Middle East and North Africa (MENA) region. The company adheres to modern quality standards and complies with Good Manufacturing Practice (GMP) regulations for food and pharmaceutical products. CinnaGen offers contract development and manufacturing services, supporting the development of biopharmaceutical products. The company specializes in biosimilars, particularly for immunological diseases, infertility, hormone disorders, and oncology. Notable products include Cinnovex, a biosimilar for multiple sclerosis, as well as therapeutic recombinant proteins, molecular diagnostic kits, and synthetic peptides. CinnaGen's products are exported to various countries, aiming to enhance patient outcomes in the healthcare sector. The company has achieved significant milestones, including being the first in the MENA region to manufacture Taq DNA polymerase and monoclonal antibodies, and it has received GMP certification from the European Medicines Agency for its biologic plant.

At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.

Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, we conduct clinical development and then select large pharmaceutical commercialization partners for out-licensing to maximize patient access across the globe. Through this specialized business model, Debiopharm can focus on the development of prescription drugs that target unmet medical needs in oncology and bacterial infections. Debiopharm completed the development and has licensed out 2 compounds: - Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®/Triptodur® 1, 3 and 6-month formulation and Moapar®/Salcacyl® -Oxaliplatin, the active substance of the branded Eloxatin®/Elplat®/Dacotin®/Dacplat® If your university or biotech start-up has interesting molecules in early-stage research and you’re seeking a competent and committed partner to develop them further, please contact us!

Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy. Dendreon’s flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient’s own immune cells. More than 40,000 men with advanced prostate cancer have been prescribed PROVENGE in the U.S. since 2010. Dendreon also is evaluating the use of PROVENGE in early-stage prostate cancer, with the hope of curing more men of the disease. Dendreon is headquartered in Seal Beach, Calif.

As a family-owned and operated business, Erbe develops, manufactures,and markets systems for professional use in various medical disciplines all over the world. Since the company's foundation, Erbe has continuously reshaped and adapted its business to an ever-changing reality in several key disciplines such as gastroenterology, general surgery, gynecology, pulmonology and urology. The portfolio comprises devices and instruments for electrosurgery, vessel sealing, plasma surgery, cryosurgery, hydrosurgery, and imaging. Over the last ten years, sales have increased by 75% with an 85% increase in employees to over 1.800 colleagues worldwide. Today, the international group of companies is represented in 110 countries around the world with sales and service units, sales and production units and an international distributor network. A dedicated team of around 260 employees works intensively in research and development. Close cooperation with renowned physicians from medical faculties and hospitals is a key success factor that helps Erbe to successfully drive medical development forward Imprint: https://de.erbe-med.com/de-en/meta-navigation/imprint/ Disclaimer: https://erbe-med.com/fileadmin/pdf/company/Terms_of_use_EN.pdf

Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients. Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing. We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI. We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.

GC Biopharma (formerly known as Green Cross Corporation, KRX: 006280) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century.

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world. It has been growing at 19% CAGR and crossed the $2.5 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in the EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 70% of its revenue coming from global business. Currently ranked 6th in the Indian pharmaceutical market, it’s the largest privately owned Indian generic pharma company. Intas has established leadership in key therapeutic segments like CNS, Cardio, Diabeto, Gastro, Urology, Oncology & Animal Health in India. We are among the top 10 generic players in the highly regulated markets of EU, US & UK. Intas operates 17 advanced formulations, R&D, and distribution facilities, of which 10 are in India and the rest in the UK, Mexico & Greece with the help of our 23,000+ Human Capital. Between them, the facilities are accredited by global regulators such as USFDA, EMA, MHRA, TGA, and others. The company invests ~6-7% of its revenues in R&D and has over 10,000 product registrations worldwide with a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars, and NDDS products. Intas' highly advanced EU-GMP Certified Biopharma division is fueled by a mission to provide affordable “Biosimilars for Billions” across niche segments such as oncology, auto-immune, ophthalmology, nephrology, rheumatology, and hormone-based therapies. The Plasma Fractionation Unit of Intas Pharmaceuticals is a pioneer in manufacturing plasma-derived therapeutics. It houses a full-fledged R&D lab and a state-of-the-art WHO-GMP-certified manufacturing facility complemented with a GLP-compliant QC lab. Our values of Innovation, Customer Delight, Ownership & Collaboration, Performance Focus & Care for Society are the driving forces toward excellence.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Meril's core objective is to design, manufacture and distribute clinically relevant, state-of-the-art and best-in-class medical devices to alleviate human suffering and improve quality of life. We thus have a strong commitment towards R & D and adherence to best quality standards in Manufacturing, Scientific Communication and Distribution known today. Origin Established in 2006, Meril was launched in line with the health-care diversification plan by a large format Indian multi-national company. Disclaimer: Information on Meril Digital / Social Media platform is not intended to be a substitute for professional medical advice, diagnosis or treatment. Meril does not recommend self-management of health issues. For more information, visit: https://www.merillife.com/disclaimer

Polaris Pharmaceuticals, is a biopharmaceutical development and manufacturing organization (CDMO) specializing in biologics derived from microbial systems. We have manufactured clinical material for trials in the United States, Europe, China, Taiwan, Australia, and Korea. Polaris Pharma offers a comprehensive range of process and analytical development and high-quality cGMP pre-clinical and clinical manufacturing services. We offer services for the following: • Process Development • Master and Working Cell Bank Propagation • Pre-Clinical/Clinical Manufacturing • QC Method Development • In Process Testing • Release Testing • Stability Storage and Testing • Availability to provide high purity WFI and PW • Custom Buffer and Media Manufacturing • Contract Filling, Labeling, Inspection • Microbial Based Fermentation Products

RECKITT BENCKISER GROUP PLC is a Consumer Goods company that offers a wide range of household, healthcare, and hygiene products.

Reprieve Cardiovascular, Inc. is developing innovative and groundbreaking therapies that aim to improve the lives of more than 25 million heart failure patients around the world. Reprieve is bringing intelligence to decongestion management to safely accelerate fluid removal for heart failure patients. In 2022, Reprieve initiated the FASTR Trial (pilot study) to compare decongestive therapy administered by the Reprieve Decongestion Management System to Optimal Diuretic Therapy in the treatment of patients diagnosed with acute decompensated heart failure. Reprieve is a privately held medical device company, headquartered in Milford, Massachusetts, USA.

ADVANCING HEALTHCARE WITH HEART CREATE YOUR FUTURE, AND OURS Here you grow your own way, you create to innovate, and learn as you go, alongside like minds who share the same commitment to the future of healthcare. We are proud to have launched global development programs to help our associates shape their careers alongside the future of healthcare. ENJOY A REWARDING AND MEANINGFUL CAREER As a team, we make a real difference to the health and wellbeing of our patients today, and leave a lasting legacy for tomorrow. Your time is dedicated to innovation, problem solving, teamwork and lifelong learning, as an integral part of our ever-curious, always committed, continually collaborative environment. We foster a growth mindset culture, embracing mistakes as an opportunity to learn, and celebrating the small wins along the way, so we can all grow together. FOR TERUMO, FOR EVERYONE, EVERYWHERE Whatever you do – marketing, engineering, sales or manufacturing – our teams look out for one another, respect and support each other in achieving our goals, and we value diversity and inclusion, empowering everyone to bring their authentic self to work. If you’re ready to advance healthcare with heart, we look forward to hearing from you.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Wockhardt is a global pharmaceutical and biotechnology organization, providing affordable, high-quality medicines for a healthier world. It is India’s leading research-based global healthcare enterprise with relevance in the fields of Pharmaceuticals, Biotechnology and a chain of advanced Super Specialty Hospitals. Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 3000 Wockhardt Associates from 21 different nationalities globally. It has 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines. Headquartered in Mumbai, India, Wockhardt has full-fledged operations in the USA, UK, Ireland and France. It also has its marketing presence in emerging markets of Russia, Brazil, Mexico, Vietnam, Philippines, Nigeria, Kenya, Ghana, Tanzania, Uganda, Nepal, Myanmar, Sri Lanka, Mauritius, Lebanon and Kuwait. Wockhardt’s core business is innovation. It uses science and technology to develop medicines and other products that improve the quality of millions people’s lives through better health. Wockhardt aspires to create a healthier world. Its strategic vision of ‘More & More with Less & Less’ has transformed into new ways of thinking, a new journey for growth, medical breakthroughs for patients and continuing value for all stakeholders.