Hanmi Pharmaceutical’s Milestones in the Pharmaceutical Industry


It wouldn’t be an exaggeration to say that the history of Hanmi Pharmaceutical, founded in 1973, has been in line with the history of the pharmaceutical industry of Korea. In fact, the company has been marking turning points in the advances of the Korean pharmaceutical industry, which had merely manufactured and sold generic drugs.

According to Hanmi Pharmaceutical, it has gained unparalleled research and development (R&D) know-how and patenting strategies by developing more than 500 different drugs over the past half-century. Armed with extensive experience and tradition, it notably has the largest number of new drug pipelines and arguably the most robust global R&D network among domestic pharmaceutical companies.

Hanmi Pharmaceutical has been leading the industry based on R&D by presenting Korea’s first incrementally modified drug, combination drug, and innovative new drug. Its history of developing pharmaceutical preparations and new drugs and obtaining licensing agreements can be traced all the way back to 1989.

During an 8-year-long patent dispute with Roche Pharmaceuticals, Hanmi Pharmaceutical proved the excellence and novelty of its manufacturing technology for ceftriaxone, an antibiotic it had developed on its own. When the situation began turning favorable for Hanmi Pharmaceutical, the global pharmaceutical giant proposed a technology transfer. As a result, the two companies signed a technology transfer agreement valued at US$ 6 million, granting Roche an exclusive right to manufacture and sell the drug in the global market, except for Korea, for 6 years from 1989.

Not only did this help catapult Hanmi Pharmaceutical to fame at home and abroad, the transfer of technology, considered an intangible asset, rather than a tangible product, demonstrated the fact that high value-added activities are possible even in the pharmaceutical industry.

During the 1997 Asian financial crisis when a large number of companies were faced with a life-and-death situation, Hanmi Pharmaceutical recorded the largest export ever in the history of the Korean pharmaceutical industry, licensing three patents related to microemulsion preparations to Novartis. This once again proved the power of Hanmi Pharmaceutical with its innovative technology and effective patenting strategy. It also gave hope to Korean citizens amid the worst recession in the post-war era.

The R&D capacity gained over decades led to multiple licensing agreements with global pharmaceutical companies in 2015 and served as a catalyst for advances in the domestic pharmaceutical industry.

Hanmi Pharmaceutical is noted for making the largest investment in R&D among its peers and dedicating itself to developing innovative new drugs to satisfy the unmet needs in medicine. The company recorded KRW 1,113.6 billion (based on consolidated financial statements) in sales in 2019 and invested KRW 209.8 billion, which was 18.8% of the total sales, in R&D. Its R&D investment over the past decade has amounted to more than KRW 1 trillion, with at least 16% of the annual sales, on average, invested back into R&D.

Based on ongoing investment, Hanmi Pharmaceutical has been securing its position as the No. 1 company in the domestic outpatient prescription market for three consecutive years since 2018. It achieved growth in the sales of its modified and combination drugs such as Rosuzet, Amozaltan, and Esomezole in 2020 and recorded KRW 666.5 billion in outpatient prescription drug sale to lead the domestic pharmaceutical industry (based on the data from UBIST).

Based on the fact that the company has been investing the profits from the sales of independently developed products back into R&D to launch innovative new drugs for the global market, it has been applauded for building a virtuous cycle of sales and R&D.

Hanmi Pharmaceutical has a total of 28 candidates for innovative new drug development to treat a wide range of diseases from metabolic disorders including obesity and diabetes to cancer, rare intractable diseases, and non-alcoholic steatohepatitis (NASH) that causes liver inflammation and fibrosis. With such multiple drug pipelines, the company has been achieving commercialization at a rapid pace based on partnerships (licensing agreements) with its peers across the world including MSD, Genentech, Spectrum Pharmaceuticals, and Athenex.

In addition to its international partnerships, Hanmi Pharmaceutical has been conducting ceaseless research to develop new drug candidates based on its independent platform technologies such as LAPSCOVERY, ORASCOVERY, and PENTAMBODY. It has also been carrying out joint research with domestic pharmaceutical firms to discover drug candidates for preclinical development and drugs for rare intractable diseases using AI to satisfy the unmet needs in medicine and made notable achievements.

Hanmi Pharmaceutical was ranked 11th in the Asia-Pacific region and 1st in Korea as an innovative pharmaceutical company by Clarivate, which provides publication data and information, attesting to its stature as a global leader in the industry.

Based on the philosophy to “make better medicines for human life, which is invaluable,” Hanmi Pharmaceutical has been fulfilling its corporate social responsibility (CSR) through a wide range of activities including the Blood Donation of Love, the longest public campaign ever to be carried out by a domestic pharmaceutical company, charity events to support migrant children and multicultural families, and donations of medicines for children in North Korea. It is also a proud patron of the arts, operating the Museum of Photography, Seoul and hosting the Sound of Light Concert.

Transformation from a Pharmacy to a World-Class Pharmaceutical Company

The precursor to Hanmi Pharmaceutical was Lim Sung-ki Pharmacy owned and operated by the eponymous founder who had graduated from the Department of Pharmacy at Chung-Ang University. The late founder known for his creativity and perseverance gained astounding success with his business in Dongdaemun, Seoul and later founded Hanmi Pharmaceutical with a vision to “make better medicines with his own hands.”

Hanmi Pharmaceutical, which is now one of the top pharmaceutical companies in Korea, attested by the fact that it recorded KRW 1,113.6 billion in sales in 2019, is operating under Hanmi Science as the holding company. In its network is a number of affiliates including Beijing Hanmi Pharmaceutical, Hanmi Fine Chemical, which specializes in manufacturing raw materials for medicines, Online Pharm, an online pharmacy selling and marketing medicines, and JVM, which develops automation systems for hospitals and pharmacies, as well as Hanmi Healthcare, which presents IT solutions for medical devices and functional foods.

Hanmi Pharmaceutical, on the other hand, is operating Hanmi Pharm. R&D Center dedicated to new drug development, Paltan Plant, the base for pharmaceutical preparation research and production, Bio Plant, the contract manufacturing site for biopharmaceuticals, and Cepha Plant for cephalosporin production.

Largest R&D Investment Among Its Peers in Korea and Striving Toward Open Innovation

Hanmi Pharmaceutical has been investing more than 18% of the proceeds from sales in R&D. The R&D investment to sales ratio, which had been 13.5% in 2012, was increased to 20% in 2014, while the total R&D investment reached KRW 192.9 billion 2018 and KRW 209.8 billion in 2019. Kwon Se-chang, President and CEO of Hanmi Pharmaceutical, says, “Innovative R&D and new drug development are essential in going beyond a top pharmaceutical company in Korea and becoming a global company” and that “the world is focusing on the new drug pipelines that [Hanmi Pharmaceutical] has developed with [its] own technology.”

Hanmi Pharmaceutical’s drug pipelines consist of bio new drugs developed with a focus on low-dose administration for enhanced effectiveness, new synthetic drugs, which are mainly next-generation targeted anti-cancer drugs, and new combination drugs for maximum therapeutic effectiveness. At present, it is carrying out 31 domestic and overseas R&D projects.

Hanmi Pharmaceutical is dedicated to developing therapeutic agents for diabetes, obesity, cancer, and diseases of the immune system and has recently been expanding into the field of treatment for rare intractable diseases. Six drug candidates currently under development have been granted Orphan Drug and Rare Pediatric Disease (RPD) designations from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

It is also striving to develop new drugs based on open innovation. It has been collaborating with GC Pharma, a domestic pharmaceutical company, in a project to develop therapeutic agents for rare diseases and formed a partnership with Phanes Therapeutics to jointly develop bi- and multi-specific antibodies. It is also making full-fledged collaborative efforts to develop new drugs using AI. A business agreement has been concluded with Standigm, an AI-based new drug developer, in an effort to develop and commercialize a wide array of innovative new drug candidates for cancer and NASH among other diseases using AI.

Anticipation of Noteworthy R&D Achievements in 2021

There are high expectations for the innovative new drugs that Hanmi Pharmaceutical in 2021. Rolontis for neutropenia and Oraxol for metastatic breast cancer are expected to be approved by the US FDA for marketing. Rolontis is the first new bio drug developed based on Hanmi Pharmaceutical’s proprietary platform technology, LABSCOVERY, while Oraxol is the sole oral paclitaxel in Korea.

In the case of efinopegdutide, whose value as a drug candidate has been proven through a licensing agreement, Phase 2 clinical trial is set to conducted with MSD to study its effectiveness against NASH. Development efforts will continue for efpeglenatide, which is currently being examined in a Phase 3 clinical trial as a drug candidate for treatment of metabolic disorders.

Hanmi Pharmaceutical has established a companywide COVID-19 responses roadmap. It either is developing or is about to launch products according to the roadmap for prevention, diagnosis, and treatment. Hanmi Cold-Mask, a nasal spray to prevent the transmission of viruses, has recently been launched with great success. Pyeongtaek Bio Plant with the capacity to ensure stable production and distribution of vaccines is also garnering a great deal of attention.

Hanmi Pharmaceutical, Developer of New Combination Drugs Incl. Amozaltan and Rosuzet

Hanmi Pharmaceutical, which had created a boom in the development of incrementally modified drugs in the domestic pharmaceutical industry with Amodipin, one such kind for hypertension treatment, launched Amozaltan, with amlodipine and losartan combined in a single dosage form in 2009. Amozaltan caused quite a sensation and recorded KRW 70 billion in sales annually, with the total sales reaching KRW 800 billion, as of 2020. A licensing agreement to sell Amozaltan in some 50 countries has been signed with MSD, a global pharmaceutical company headquartered in the United States.

The Amozaltan family has been established with the release of Amozaltan Plus, which contains chlorthalidone, a diuretic that effectively lowers blood pressure, and Amozaltan Q, which contains rosuvastatin used to treat hyperlipidemia. In 2020, the annual sales of the Amozaltan family surpassed KRW 100 billion, the best record ever for a combination drug developed by a Korean pharmaceutical company.

Amozaltan, the fruit of integrating the drug preparation technologies of Hanmi Pharmaceutical, has been patented in 45 countries including Korea, the United States, and Japan. Also, eleven clinical research papers have been published in international scientific journals including those indexed by SCI. Hanmi Pharmaceutical has been published at least one paper concerning the Amozaltan family in an international journal each year and presenting related research at major conferences at home and abroad.

Hanmi Pharmaceutical has recently received marketing approval from the authorities for Amozaltan XQ, which contains four active ingredients: amlodipine and losartan, which are used to treat hypertension, and rosuvastatin and ezetimibe, which are used to treat dyslipidemia. As a result, the Amozaltan family consists of four products administered at eighteen different doses.

Rosuzet, a combination drug for dyslipidemia, recorded KRW 90 billion in sales in 2020, five years after its launch, and ranked No. 1 among combination drugs for dyslipidemia and No. 2 among outpatient prescription drugs (based on the data from UBIST). 특히, 지난 2018년 한국지질동맥경화학회에선 3만5000여명의 EMR(Electronic Medical Record) 데이터를 분석한 Real world 연구 결과를 소개하기도 했다. In 2018, the Korean Society of Lipidology and Atherosclerosis published the results of a real-world study in which the electronic medical records of some 35,000 patients taking Rosuzet were analyzed.

Hanmi Pharmaceutical has a total of fourteen ethical-the-counter (ETC) drugs that shattered the KRW 10 billion annual sales mark in 2020 (based on the data from UBIST). All fourteen of these drugs were developed independently by the company, and they include Amozaltan (KRW 82.1 billion), Amozaltan Plus (KRW 24.8 billion), Rosuzet (KRW 99.1 billion), Esomezole (KRW 40.5 billion), PalPal (KRW 44.8 billion), Amodipin (KRW 23.8 billion), and Hanmi Tams (KRW 22.1 billion) The company recorded a total of KRW 445.6 billion in sales with these fourteen products alone.

Beijing Hanmi Pharmaceutical, a Success Model of Entering the Chinese Market

Beijing Hanmi Pharmaceutical, a local subsidiary in China, is regarded to have achieved the greatest success in entering the Chinese market. In fact, in “Korean Companies Going Global,” a report issued by the Korea International Trade Association (KITA) in 2013, Hanmi Pharmaceutical was named as one of the companies that successfully expanded into the global market.

Beijing Hanmi Pharmaceutical, established in 1996, is staffed with around 1,600 local employees for research, sales, production, and other fields. The late founder and chairman Lim Sung-ki had begun traveling to China five years before the establishment of diplomatic ties between Korea and China so as to develop the market in phases. As a result, Hanmi Pharmaceutical became the first Korean pharmaceutical company to obtain product approval (for an antibiotic called cefotaxime) in 1992 immediately following the establishment of diplomatic relations.

Beijing Hanmi Pharmaceutical is achieving marked growth with medicinal products for children. This was the result of the efforts made by the late chairman, who decided to dedicate all efforts to the production of medicines specifically for children after seeing medicines for adults being broken to be administered to kids. The tendency for parents to become overprotective of their children, a result of the one-child policy, also contributed to the growth of Beijing Hanmi Pharmaceutical.

Beijing Hanmi Pharmaceutical achieved considerable success with the release of Mamiai, an intestinal drug for children. It became a blockbuster drug recording nearly KRW 80 billion in annual sales and was given a “famous trademark” recognition by the Chinese government, which had been unprecedented for a Korean pharmaceutical company.

The independent R&D center established by Beijing Hanmi Pharmaceutical in 2008 is serving as an advance base for the company with researchers who have graduated from prestigious universities in the country including Peking University, Tsinghua University, and China Pharmaceutical University in Nanjing. Armed with top-notch researchers and related infrastructure, the company is capable of production, sales, and R&D. In addition to Mamiai, its flagship product, Beijing Hanmi Pharmaceutical is also marketing some 20 other products including Yitanjing, an antitussive expectorant, and Maechangan, an intestinal drug for adults. It is currently developing five to six new drugs for cancer and metabolic disorder treatment.

The sales personnel of Beijing Hanmi Pharmaceutical are playing an important role in establishing trust in the company with their academic background in either medicine or pharmacy.

The company has also been achieving excellent sales records, raking in KRW 254.4 billion in sales in 2019, an 11.5% year-over-year growth. It invested around KRW 25 billion, approximately 10% of the sales, in R&D in order to take a greater chunk of the market.

A Philanthropic Company Fulfilling CSR Through the Blood Donation of Love, etc.

Based on the philosophy to “make better medicines for human life, which is invaluable,” Hanmi Pharmaceutical has been fulfilling its corporate social responsibility (CSR) through a wide range of activities including the Blood Donation of Love, the longest public campaign ever to be carried out by a domestic pharmaceutical company, charity events to support migrant children and multicultural families, and donations of medicines for children in North Korea. Instead of just making one-time donations, it is dedicated to creating a sustainable charity model aimed at promoting self-sufficiency among beneficiaries.

The Blood Donation of Love Campaign, which has become one of the most prominent campaigns conducted by pharmaceutical companies, has had 8,218 participants who donated 2,629,760cc of blood in total over the course of 41 years. In response to critical blood shortages due to COVID-19, the company has increased the frequency of its blood drives at its offices and business establishments to four times a year.

Hanmi Pharmaceutical is a proud supporter of the arts. Gahyeon Cultural Foundation, established to serve the public interest, operates the Museum of Photography, Seoul, the first photography museum ever to be established in Korea. The company also hosts an annual concert called the the Sound of Light Concert to provide children with disabilities a chance to enjoy the arts. As a pharmaceutical company endeavoring to promote the health of mankind, Hanmi Pharmaceutical’s ultimate objective is to give back to society by fulfilling its CSR and become respected and admired by the people of Korea.

Emerging as a Global Pharmaceutical Company Based on Hanmi-Way

Hanmi Pharmaceutical has been a trailblazer since its beginning. It created a boom of incrementally modified drugs and combination drugs in the domestic pharmaceutical industry, brought forth new drugs at an unparalleled rate based on R&D, and revolutionized the distribution of pharmaceutical products.

Under the slogan, “Relentless Endeavors and New Resolve to Become a Pharmaceutical Powerhouse,” declared in 2021, Hanmi Pharmaceutical plans to emerge as a global pharmaceutical giant with its robust capacity to develop new drugs and the hard work and dedication of its executives and employees.

Source: Seoul Wire