List of Biologics Companies in Italy - 31

Alia Therapeutics is a pioneering gene editing company with a vision to revolutionize medicine by curing genetic diseases at their roots. Alia’s versatile portfolio of novel CRISPR systems expands the range of targetable genomic sites and increases the precision of genetic modifications, bringing gene editing to the next level of specificity and safety, which are required for therapeutic applications.

Altheia Science is a pioneering start-up founded by two world renowned Italian scientists, Prof. Alessandra Biffi, MD and Prof. Paolo Fiorina, MD, PhD, together with AurorA-TT. Altheia Science’s pipeline exploits pioneering therapeutic tools for autoimmune diseases and cancer. The modulation of PD-L1 expression at the molecular and protein level is key to devise advanced treatments. This can be achieved by first-in-class molecules controlling the PD-L1 pathway and/or by lentiviral vector-based engineering of patients’ hematopoietic stem cells. Altheia Science’s approach intends to drastically modify the natural history of diseases with high clinical impact in autoimmunity and cancer by modulating PD-L1 expression, achieving tangible and durable benefit for each patient.

Anemocyte is an Italian Biotech Manufacturing Organization with a strong focus on the development, manufacturing, and analytical services to address needs in the field of: • pDNA – Plasmids manufacturing (R&D, Hiqh-Quality, and GMP) for Viral Vector and mRNA; • mRNA – mRNA manufacturing (R&D) for vaccines and therapeutic treatments. Our experience: • More than 20 years of development and manufacturing experience (from R&D to GMP) in the field of Cell and Gene Therapies and Nucleic Acids. • Over the years, Anemocyte has been involved in multiple projects with a wide range of complexity.

BetaGlue Therapeutics is a clinical stage oncology company that has developed an advanced radiotherapy platform enabling localised targeted treatment of both unresectable solid tumours and also treatment of surgical resection margins called YntraDose.

BIOGENERA SpA is a company operating in the biotechnology pharmaceutical sector, specialising in the research and development of new DNA-based patient-specific biotechnological medicines for the treatment of serious pathologies. Founded in 2008, with its headquarters in Bologna, BIOGENERA SpA has a multidisciplinary team of researchers and is supported by numerous University partnerships ( in particular, the University of Bologna) and other companies of the pharmaceutical sector.

Borea Therapeutics develops next-generation gene therapy vectors using a knowledge-based capsid design platform

Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making.  As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

Contraria Biotech (formerly AchilleS Vaccines) is a biopharmaceutical development company that aims to create sustainable therapeutic and prophylactic drugs against infectious diseases. We are committed to designing innovative, cost-effective therapeutic and prophylactic products to address some of today's major global health problems, including antibiotic resistance, emerging diseases and pandemics.

Founded in 2002 in Cartoceto (PU), Italy, Diatheva is a biotechnology company established as a spin-off from the University of Urbino. 70% of all employees holds at least a PhD and oversees all phases of activity, from research and development to production and finishing. For 20 years, Diatheva has been engaged in the research, development, and production of: - biotechnological products: including monoclonal and polyclonal antibodies, antibody fragments, recombinant proteins, recombinant enzymes, and antigens - molecular and immunoenzymatic assays: such as in vitro diagnostics (IVD), veterinary kits, food analysis kits, and environmental kits. To achieve this, Diatheva collaborates with companies, public and private entities, mainly operating in the fields of oncology, microbial infections, and pharmacogenetics. Diatheva operates a cutting-edge GMP production facility authorized by AIFA since 2006 for biomolecules (APIs) and since 2023 for medicinal products.

Dompé farmaceutici is an international biopharmaceutical company involved in all activities of the pharmaceutical value chain, from research to development, production and marketing. As a long-established family company, we blend the stability that comes from our 130-year heritage with the agility and dynamism of a start-up. We can turn transformative breakthroughs into treatments because we have the right qualities and capabilities to deliver new drugs. Our 160,000 square meter R&D and production site in L’Aquila, Italy, is the heart of Dompé. Here, we conduct vital research, and produce and distribute our primary care and biotech products. Primary Care includes a broad spectrum of over-the-counter treatment solutions, prescription medications, supplements and medical devices. Our Biotech focuses on the development of treatments for rare diseases. The main therapeutic areas include pain relief, inflammation, ophthalmology, diabetes care, nutrition and oncology. In the pursuit of improving human health, our R&D strives to break through in unconventional places. This is what led us to Nerve Growth Factor (NGF), a Nobel Prize-winning discovery made in 1986. We leveraged 50 years of research to transform this discovery into a breakthrough treatment. Our human recombinant NGF, cenegermin, is the first treatment for a rare degenerative eye disease, neurotrophic keratitis. That deep appreciation of science keeps us committed to investigating neurotrophins. Our relentless pursuit in identifying new treatments for diseases allowed us to harness the potential of bioinformatics to accelerate the drug discovery process. The result is Exscalate, a structure-based virtual screening platform developed in-house and currently one of the most powerful supercomputing and artificial intelligence platforms for drug testing. We are focused on the road ahead. Our hunger to deliver what patients need from science keeps us focused on what matters. We embrace the challenge in science.

We develop first-in-class biologics for several underserved autoimmune conditions. Our therapeutic approach aims to preserve and re-establish organ cell function, transforming the treatment paradigm for intractable autoimmune diseases

Etna Biotech srl - Zydus Cadila Research Center is a company based out of Italy.

Galileo Research origins lie in 1972 as the Research Centre of Istituto Gentili, an Italian pharmaceutical company founded in 1917. At the beginning of the ‘80s, scientists at the Gentili Research Centre discovered and developed new molecules in the class of bisphosphonates and in the field of bone diseases, in particular clodronate and alendronate. The Research Centre continued to work in the field of bone and joint metabolism and also expanded its knowledge and activities to the areas of oncology and CNS. Galileo Research was established in July 2011.

Genenta (Nasdaq: GNTA) is a clinical stage immuno-oncology company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors. Our platform is not tumor type nor target antigen restricted and provides sustained targeted expression of therapeutic payload(s) inside the tumor micro environment. Genenta’s lead product candidate, Temferon™, precisely targets the delivery of interferon-alpha to the tumor micro-environment, minimizing systemic toxicity while breaking tumor-induced immune tolerance. Our treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Genespire is a biotechnology company focused on the development of durable and transformative gene therapies for patients affected by genetic diseases, particularly primary immunodeficiencies and inherited metabolic diseases. Based in Milan, Italy, Genespire was founded in March 2020 by the gene therapy pioneer Prof. Luigi Naldini, Dr. Alessio Cantore, Fondazione Telethon and Ospedale San Raffaele. It is a spin-off of SR-Tiget, a world leading cell and gene therapy research institute and is backed by Sofinnova Partners.

Heqet Therapeutics is a company that develops groundbreaking genetic medicines to reverse the damage of ischemic heart disease, the leading cause of death worldwide. Their therapeutic approach aims to address the underlying drivers of heart disease.

Holostem Terapie Avanzate is the first biotechnological company entirely devoted to development, manufacture, registration and distribution of Advanced Therapies Medicinal Products (ATMPs) based on cultures of epithelial stem cells both for cell and gene therapy. The main aim of Holostem Terapie Avanzate is to promote epithelial stem cell-based Regenerative Medicine for patients with no alternative therapeutic solutions. Holostem Terapie Avanzate is located into the Centre for Regenerative Medicine "Stefano Ferrari"​ of the University of Modena and Reggio Emilia

The International Centre for Genetic Engineering and Biotechnology ICGEB is an intergovernmental research organisation that operates within the United Nations common system. It was established in 1983 as a Centre for excellence in research, training and technology transfer to industry in the field of biotechnology to promote sustainable global development. With over 60 Member States and 40 Affiliated Centres worldwide, it runs 46 research programmes in its own laboratories in Trieste, Italy, New Delhi, India and Cape Town, South Africa. Almost 700 people work at ICGEB comprising 550 scientific personnel. The organisation has generated almost 3000 scientific publications in the Life Sciences since 1988 and currently holds over 80 active research grants. ICGEB has awarded almost 1400 fellowships, with over 300 fellows and 150 PhD students currently on board. It has organised over 560 Meetings and Courses worldwide and has funded over 550 Collaborative Research Programme-Research Grants. It has produced and distributed over 600 movies (podcasts) of high-scientific content in 50 topics in the Life Sciences - that are freely available for download on iTunes, YouTube and on the ICGEB Web site. Active in Public Engagement and on Social Media networks, ICGEB invites, in particular, its Alumni to join the ICGEB Alumni Group on Linkedin. http://www.icgeb.org

Kither Biotech is a biopharmaceutical company that develops novel therapies for the treatment of rare pulmonary diseases with an high unmet medical need. Our first two product candidates KIT2014 and KITCL27, focus on cystic fibrosis and idiopathic pulmonary fibrosis respectively.

MediaPharma Srl is a preclinical stage biotech company focusing on research and development of monoclonal antibodies, Antibody-Drug Conjugates (ADCs) and other products for the treatment of cancer and other severe diseases with high unmet medical needs. At MediaPharma, scientists, doctors and entrepreneurs share the same values and have been working together for years.

The Menarini Group is a leading international pharmaceutical and diagnostics company, present in 140 countries worldwide, with a turnover of €4,155 million and more than 17,000 employees. With 9 centers for Research & Development, Menarini’s products are present in the most important therapeutic areas, including cardiology, oncology, gastroenterology, pneumology, infectious diseases, diabetes, and anti-inflammatory/analgesics. The Group’s pharmaceutical production is carried out in its 18 manufacturing plants, which produce over 578 million packets of product a year and distribute them to five continents. Menarini’s pharmaceutical production, in line with the highest quality standards, provides an ongoing contribution to the health of patients all over the world.

NanoPhoria is a preclinical stage biotech company pioneering inhalable cardiovascular treatments via non-viral nano-delivery of biologics. The Company is devoted to the clinical development of an innovative proprietary platform for the tissue-directed delivery of therapeutic peptides and RNAs. The core vehicle is an inorganic calcium-phosphate nanoparticle which represents a versatile, biomimetic nano-carrier that can be loaded or surface decorated with biologics and can be formulated for inhalation or for other administration routes. NanoPhoria's lead product, NP-MP1 is an inhalable nano-in-micro formulation, delivering a proprietary peptide, first-in-class calcium channel modulator, for the treatment of Heart Failure with reduced Ejection Fraction, a chronic syndrome affecting the lives of millions worldwide.

Nerviano Medical Sciences S.r.l. (NMS Srl) focuses on discovering and clinically developing small molecule NCEs for oncology, aiming to deliver first- and best-in-class personalized cancer treatments through innovative mechanisms and novel drug targets. Our pipeline, built from our validated kinase platform, includes projects from early preclinical to clinical stages, advanced both internally and in partnership.  NMS Srl combines biotech agility with big pharma quality, guided by an experienced management team and a skilled staff with global expertise in research, drug discovery, and clinical development. Our capabilities are extended by NMS Group affiliates Accelera (AdMet) and NerPharMa (manufacturing), covering the entire drug development process. A core strength lies in our renowned kinase inhibitor platform, featuring an extensive chemical library and IP coverage, which has led to successful out-licensing deals, including with encorafenib and entrectinib. Additionally, we are advancing a PARP-family-focused platform to discover NCEs targeting NAD-binding pockets, with potential expansion to other NAD-dependent enzymes. Our growing payload-linker platform further enhances our pipeline by enabling next-generation ADC production. Collaborating globally with academic, clinical, and industry partners, we seek further strategic alliances to develop, commercialize, and expand our product portfolio while exploring in-licensing opportunities for promising clinical assets.

Philogen is a Swiss-Italian integrated biotechnology company founded in 1996, with the mission to develop innovative biopharmaceuticals for the treatment of angiogenesis-related disorders. Angiogenesis, i.e. the formation of new blood vessels, is a characteristic feature of many severe pathologies such as cancer, rheumatoid arthritis and age-related macular degeneration. The company has been a pioneer in the isolation, engineering and clinical development of lead products capable of targeting angiogenesis in-vivo and has been the first in the world to demonstrate that human monoclonal antibodies, specific for a marker of angiogenesis, can efficiently and selectively target the tumor neo-vasculature both in animal models and in cancer patients. At present, Philogen has four promising anti-cancer antibody derivatives and an antibody derivative for the treatment of rheumatoid arthritis in clinical studies. Two registrational studies are in planning. Our Zurich-based daughter company Philochem serving as the R&D unit isolates the most promising candidate products, while in Siena (Italy) the pharmaceuticals are produced according to GMP standards and advanced to clinical trials. Philogen generates revenue from a diversified range of activities, has signed agreements with major pharmaceutical companies and owns a diversified portfolio of international patents.

Politecnico Milano is a scientific-technological university which trains engineers, architects and designers. The University has always focused on the quality and innovation of its teaching and research, developing a fruitful relationship with business and productive world by means of experimental research and technological transfer. Research has always been linked to didactics and is a priority commitment which has allowed Politecnico Milano to achieve high quality results at an international level as to join the university to the business world. Research constitutes a parallel path to that formed by cooperation and alliances with the industrial system. Knowing the world in which you are going to work is a vital requirement for training students. By referring back to the needs of the industrial world and public administration, research is facilitated in following new paths and dealing with the need for constant and rapid innovation. The alliance with the industrial world, also favored by Fondazione Politecnico and by consortiums to which Politecnico belongs, allows the university to follow the vocation of the territories in which it operates and to be a stimulus for their development. The challenge which is being met today projects this tradition which is strongly rooted in the territory beyond the borders of the country, in a relationship which is developing first of all at the European level with the objective of contributing to the creation of a single professional training market. Politecnico takes part in several research, sites and training projects collaborating with the most qualified European universities. Politecnico's contribution is increasingly being extended to other countries: from North America to Southeast Asia to Eastern Europe. Today the drive to internationalization sees Politecnico take part in the European and world network of leading technical universities and offers several beside many which are entirely taught in English.

ReiThera is a company devoted to developing and producing biopharmaceutical products based on gene delivery technologies doe advanced therapies, in order to prevent and treat several serious or life-threatening diseases.

Discovering and developing novel drugs has been our passion, work and mission for over 50 years. Rottapharm Biotech lives for innovation and innovation lives at Rottapharm Biotech. This is all we are and all we want to be.

StemGen is a clinical stage biotech company developing innovative differentiation biotherapies for cancer. StemGen is also involved in research on neural stem cells.

Takis is a biotech dedicated to cancer research. Our primary objective is the development of innovative therapies based on the principle that our immune system can be “instructed” to recognize the tumor and reject it as a foreign entity. For this purpose, Takis offers cutting-edge technologies and works with the idea that new cancer treatment must be based on in-depth knowledge of tumour biology and the concept of personalized cancer therapy. Together with some of its partners, Takis is involved in the identification of new biomarkers and in the development of molecular diagnostic tests. The main competence of Takis’ researchers is the delivery of genes in vivo through numerous technologies. The foremost one is the electric transfer of genes (gene-electro-transfer–EGT) on which we have more than ten years experience. This technology can significantly increase the tissue uptake of nucleic acids in vivo, such as skeletal muscle, or the tumor itself, with a functional enhancement that leads to relevant immunological and antitumoral effects. In this regard, In addition to its research pipeline, Takis is engaged with academic and industrial partners in research aimed at studying the effectiveness of innovative drugs in biological systems or develop diagnostic tests based on the detection of new biomarkers. Takis offers itself as partner of choice because of its efficiency, speed of execution and low operating costs.