PHARMACY MARKET

EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)

CureVac, EMA | February 18, 2021

The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.

The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.

The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.

Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.

The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.

EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.

About CVnCoV
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.

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Pharmaceutical manufacturers are implementing vacuum conveying technologies to deliver drugs to consumers faster, safer and more economically. Vacuum technology provides safer transfer of dry bulk materials and allows pharmaceutical processors to meet tight industry standards for sanitation and environmental safety.


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RESEARCH

DEBIOPHARM INVESTS IN VERISIM LIFE'S $15M SERIES A ROUND TO ADVANCE AI-ENABLED DRUG RESEARCH

Debiopharm International SA | January 11, 2022

Debiopharm a Swiss biopharmaceutical company, announced their co-investment in California-based start-up VeriSIM Life's $15 Million Series A Round to advance their mission to accelerate drug development via technology powered by artificial intelligence. VeriSIM Life's computational platform reduces time and cost of drug development as well as reduces the need for animal testing that, in the vast majority of cases, does not translate well to humans. Debiopharm's co-investment in VeriSIM contributes to the growth plan of the start-up and will help to expand and establish transformational partnerships with industry and academia using their first-in-class 'virtual drug development engine' BIOiSIM™. The investment aligns with Debiopharm's focus to invest in digital health solutions that improve the cancer patient journey, transform pharmaceutical R&D, and shift healthcare towards a more patient-centric approach. With the financing round led by Morpheus Ventures, Debiopharm Innovation Fund joins new investors including Colorcon Ventures along with existing investors OCA Ventures, Intel Capital, Serra Ventures and Susa Ventures. Founded in 2017 by Jo Varshney, DVM and PhD alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts, the start-up offers a range of translational-based solutions, customized for pre-clinical and clinical programs. "We're moving into a time where AI-based technology will play a critical role in drug development. We absolutely need to reduce the time, costs & risks of drug development in order to be more efficient – that's exactly what the BIOiSIM™ is proven to do. The value of using this AI-based platform is the potential decrease in the need for animal testing and the acceleration of the pre-clinical, translational stage, helping drug research companies to more quickly select which early-stage medicines will most likely benefit patients and cure their disease." Tanja Dowe, CEO of the Debiopharm Innovation Fund More than 90% of drugs tested in animals fail to pass human clinical trials, resulting in delayed development and high costs. VeriSIM's BIOiSIM platform, driven by AI and machine learning (ML), de-risks R&D decisions by providing meaningful insights much earlier in the drug development process with unprecedented accuracy and scalability. VeriSIM's platform solves this decade-old translatability problem within the drug development phase and ensures clinical success of drugs intended for highly unmet needs. With its first-in-class platform, VeriSIM is transforming the way pharmaceutical and biotech companies address the most challenging diseases impacting humankind. About VeriSIM Life VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to significantly improve drug discovery and development by greatly reducing the time and money it takes to bring a drug to market. BIOiSIM is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program not only reduces the time and cost of drug discovery and development, it also greatly reduces the need for animal testing that, in the vast majority of cases, does not translate to humans. Debiopharm's commitment to patients Debiopharm develops, manufactures and invests in innovative therapies and technologies that respond to high unmet medical needs in oncology and bacterial infections. We aim to provide strategic funding and guidance for companies with Smart Data & Digital Health solutions with the ambition to change the way drugs are developed and the way patients are treated. Our growing portfolio company achievements includes 18 FDA clearances or CE marks and 2 IPOs. Since 2018 Debiopharm has invested over USD 120 million, typically leading the investment rounds of its 16 portfolio companies.

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BUSINESS INSIGHTS

SiO2 Materials Science and Doosan Corporation Enter Into Strategic Partnership to Accelerate Market Development in Asia

SiO2 Materials Science | December 27, 2021

Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies. As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period. "The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market," says Lawrence Ganti, President of SiO2 Materials Sciences The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months. "South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan. "There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation. About SiO2 Materials Science SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard. About Doosan Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.

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BUSINESS INSIGHTS

Daewoong Pharmaceutical and HanAll Biopharma Invest in Turn Biotechnologies to Expand Growth Initiative

Daewoong Pharmaceutical and HanAll Biopharma | April 12, 2022

Daewoong Pharmaceutical and HanAll Biopharma announced expansion of their open collaboration strategy by investing in Turn Biotechnologies, a Silicon Valley based company focused on developing novel mRNA medicines. The companies are supporting Turn Bio's continued development of a high-potential platform and are considering future long-term collaborations. Turn Bio is a pre-clinical-stage biopharmaceutical company focused on cellular repair via epigenetic reprogramming of cells. The technological foundation for Turn Bio's proprietary Epigenetic Reprogramming of Age (ERA™) methodology was developed by Turn Bio's co-founders in the Sebastiano Lab, Institute for Stem Cell Biology and Regenerative Medicine, Stanford School of Medicine. The technology has since been patented and Turn Bio is currently using it to complete pre-clinical research on therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteoarthritis and the muscular system. "Many age-related diseases have long been significant areas of patients' unmet need. Turn Bio's innovative platform may bring a pivotal transformation to a wide array of therapeutic areas. HanAll is committing support and investment to help realize the full potential of this pioneering technology as Turn Bio advances to a new phase of growth." Dr. Almira Chabi, chief medical officer and chief development officer at HanAll Pharmaceutical International "The support of Daewoong Pharmaceutical and HanAll Biopharma validates our approach to cellular rejuvenation and enables Turn to expand its efforts in multiple therapeutic indications," said Anja Krammer, the company's CEO. "We are thrilled that a company as well known for its innovation, has taken interest in our promise to transform the way medicine treats diseases of aging and we look forward to further collaborations to help change quality of life and healthcare economics globally." The proceeds from this round of financing will support Turn Bio's advancement towards a phase 1 trial of its mRNA therapy candidate TRN-001, which targets indications in dermatology. About HanAll Biopharma Co., Ltd. HanAll Biopharma is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 48 years. HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. About Daewoong Pharmaceutical. Co., Ltd. Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on its course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide. About Turn Biotechnologies Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level. The company's proprietary mRNA platform technology, ERA™, restores optimal gene expression by combatting the effects of aging in the epigenome. This restores the cells' ability to prevent or treat disease, and heal or regenerate tissue and will help to fight incurable chronic diseases.

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PHARMACY MARKET

Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate. Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators. "HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed About HBM9378/SKB378 HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. About Asthma Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO). Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma. About Harbour BioMed Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

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Spotlight

Pharmaceutical manufacturers are implementing vacuum conveying technologies to deliver drugs to consumers faster, safer and more economically. Vacuum technology provides safer transfer of dry bulk materials and allows pharmaceutical processors to meet tight industry standards for sanitation and environmental safety.

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