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    Humanity has relied on nature for sustenance and medicinal remedies to maintain life and cure diseases. Propheta develops new medicines using natural and low-side-effect ingredients. We focus on antibody development through research on cyclically occurring viruses. 

   The pharmaceutical industry in India is a massive $43 billion market, growing at an average of 9.5% annually. As the world's largest generic drug supplier, we supply approximately 20% of the global demand and provide 62% of the world's vaccine supply.

   Propheta ensures the highest standards of safety and infrastructure with WHO-GMP and EDQM approvals, offering the best opportunities to uphold a healthy lifestyle for humanity. - 

                     - Director. Kislay Kumar

The History of 'Medicine'

   When did humanity begin developing and using medicines? The exact origins of medicine are not known, but it is believed to have evolved from the realization that some plants gathered directly from nature could be poisonous, while others had medicinal properties. Thus, the use of medicinal herbs (phytotherapy) emerged, where plants were consumed based on their effects on symptoms. Over time, this led to the extraction of medicinal components from medicinal plants, further advancing the field of medicine.

   In the Western world, there are records of medications and prescriptions in the cuneiform tablets of the Sumerians around 4,000 years ago, and in the papyri of ancient Egyptians dating back to around 1550 BCE. In the Eastern world, the earliest documentation of herbal medicine is found in the Shennong Ben Cao Jing, dating back to the 3rd century BCE.

   In summary, medicine originated from the use of medicinal plants and herbs, and until the 18th century, people consumed them either directly or after simple processing such as boiling and drying.

 

The Birth of 'Morphine' and 'Aspirin'

   In the 19th century, German chemist Friedrich Sertürner succeeded in extracting the analgesic component morphine from opium, marking a significant milestone in the development of medicines. The isolation of morphine as a single active ingredient sparked a trend across Europe, leading to the separation of effective physiologically active substances from medicinal herbs. This, in turn, led to the isolation of various other components, such as quinine for malaria treatment, cocaine as a stimulant, and digoxin as a cardiac drug, which were eventually used as real medications.

   In 1897, this progress in medicine went beyond extracting natural compounds to synthesizing medicinal components. It was the synthesis of aspirin. Historically, the bark of willow trees, which is the raw material for aspirin, had been used for pain relief and fever reduction since ancient times. However, it was Dr. Felix Hoffmann of Bayer in Germany who successfully synthesized pure and stable aspirin, which was then introduced to the market under the brand name "Aspirin." This can be regarded as the beginning of the pharmaceutical industry.

 

The Discovery of Antibiotics in the 20th Century

   One of the most significant events in the history of medicine is the discovery of antibiotics. Among the multitude of drugs that emerged in the 20th century, penicillin, the first antibiotic, stands out as the undisputed champion and is considered one of the greatest inventions of the 20th century for humanity.

   In 1928, British scientist Alexander Fleming (1881-1955) discovered penicillin, an antibiotic substance that inhibited bacterial growth, from a petri dish culture of blue-green mold. This remarkable discovery made a profound contribution to overcoming various infectious diseases, and during World War II, it played a pivotal role in saving the lives of countless soldiers.

   The advent of antibiotics marked a revolutionary turning point in medicine, ushering in a new era of combating infections and significantly improving human health.

The Balance Between Safety and Efficacy

   As the 20th century unfolded, the development of new drugs gained momentum, but there was still a shortage of variety and quantity compared to the demand for medications. Therefore, the emphasis was placed more on the efficacy of drugs rather than their safety. However, a tragic incident occurred when thalidomide, developed in Germany, was taken by pregnant women, resulting in the birth of babies with limb deformities, including missing limbs and hands attached to the shoulders.

   Thalidomide had been promoted as a miraculous drug without side effects due to minimal adverse reactions observed in various animal experiments. It was primarily used in Germany and the UK before being introduced in more than 50 countries. However, in the 1960s, pregnant women who had taken this drug gave birth to children with deformities. In Germany alone, over 5,000 babies were affected, and the number exceeded 500 in the UK. Thalidomide-induced birth defects surpassed 10,000 cases in 46 countries. Consequently, thalidomide sales were halted, and it remains one of the most tragic cases in pharmaceutical history related to drug side effects.

   This event prompted a shift in mindset, recognizing that safety should take precedence over efficacy when developing medications.

 

Efforts for Humanity in the 21st Century

   Even in the present day, pharmaceutical and biotechnology companies around the world are dedicating themselves to the development of new medications that will safeguard and maintain human health. When we examine the types of medications currently under development, it is evident that there is a significant focus on antibody development through cancer and virus research. Whenever the topic of medications is discussed, a common reminder is that even highly effective and beneficial drugs for treating diseases can become lethal poisons if used incorrectly. Just like most things in the world, the true usefulness of medications can be maximized when used appropriately and in the right manner.

Natural-Derived New Drug Development Status

   1) Global Development Trends: The global natural-derived market, including pharmaceuticals and health functional foods, is estimated to be worth around 1,000 trillion won (Korean currency) with an annual growth rate of 8~10%. Both domestically and internationally, countries are showing initiatives to gain leadership in the natural-derived market. In the pharmaceutical sector, the market size and share of natural-derived products are still relatively small.

  In the United States, it accounts for only 0.01% of the total pharmaceutical market, valued at 17.5 billion dollars, while in Europe, it is 1.1% worth 2.1 billion dollars. However, China leads the natural-derived market with the largest share, amounting to 23% with a market size of 18.6 billion dollars. Since the U.S. FDA established the natural-derived drug guideline in 2004, more than 400 natural-derived new drug candidates have applied for clinical trials in the United States.

Natural-Derived New Drug Development Status

   1) Domestic Development Trends: Natural-derived new drugs are pharmaceuticals developed from natural ingredients, and they consist of compositionally new pharmaceuticals and various synthetic compounds. To avoid fluctuations in efficacy, standardized quality equivalence must be ensured from raw material collection to the manufacturing process. Quality control of the ingredient profile of natural-derived new drugs is a reliable method to guarantee clinically proven efficacy and ensure quality homogeneity based on manufacturing numbers. The guidelines include target and scope of the ingredient profile, methods for securing and verifying the ingredient profile, and evaluation criteria. The Korea Food and Drug Administration (KFDA) has prepared evaluation methods for quality equivalence based on the ingredient profile between approved raw materials, traditional Korean medicine formulations, and equivalent products even among different formulations. The final version of the guidelines for establishing the ingredient profile of natural-derived new drugs has been released by the KFDA.

   2) According to the Pharmaceutical and Bio-Industry Association, a survey was conducted on 100 domestic pharmaceutical companies regarding their new drug pipelines (candidate substances). The results showed that there are 573 new drug pipelines under development by domestic pharmaceutical companies, and 380 new drug pipelines are scheduled for development within the next 10 years. Among them, only 31 candidates have entered the final clinical stage (Phase 3) of development. The field with the most new drug pipelines among domestic pharmaceutical companies is oncology, with 178 candidates, followed by infectious diseases (58), others (52), immune diseases (47), and endocrine diseases (46). In terms of type, biopharmaceuticals account for 433 candidates, representing 45.4% of the total. Considering the proportion of natural-derived new drugs compared to other fields, there is significant demand for the development of natural-derived new drugs, and ongoing development holds a crucial importance.

Natural-Derived New Drug Development Future Directions

   1) Looking back at the history of pharmaceutical development, it began with natural-derived compounds and evolved into small-molecule pharmaceuticals using organic synthesis techniques, followed by the emergence of high-molecular-weight pharmaceuticals employing biotechnology (biopharmaceuticals, antibody drugs, etc.). In recent times, active research is being conducted in gene therapy and regenerative medicine as well. In this historical context, there is a global movement valuing the diversity of chemical and biological entities found in natural-derived compounds as potential sources for new drug seeds. Beyond traditional natural-derived new drug development, innovative research in related fields, utilizing technological breakthroughs, and exploring the potential of natural compounds from a chemical and life sciences perspective are highly anticipated.

   2) The current situation, where the possibility of natural-derived pharmaceuticals is being prominently recognized as a potential path for the domestic pharmaceutical industry, which has a strong focus on generic drugs, is highly welcomed. Natural-derived pharmaceuticals possess characteristics that make development relatively easier, have minimal side effects, and exhibit therapeutic efficacy and applicability well-suited to the changes in social environments. These features make natural-derived pharmaceuticals a promising opportunity for domestic pharmaceutical companies.

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