GE LI Pharmaceutical
Founded in 2013, Gloria Pharmaceuticals (01672) is an integrated anti-virus platform dedicated to addressing the unmet medical needs of the three major therapeutic areas of antiviral, cancer and fatty liver diseases, covering the exploration and development of new drugs. Until the complete value chain of production and commercialization. The company specializes in the development and commercialization of best-in-class innovative drugs against HCV (hepatitis C virus), HIV (HIV) and HBV (hepatitis B virus).
The company currently has five antiviral drug discovery and development programs, including two hepatitis C research drugs at or near the commercial stage and one HIV-based drug that has completed Phase IIa clinical trials. In addition, the company has a liver cancer research drug that has completed Phase I and Phase I extended clinical trials. The company's core products include Gonowo, Ravi Davi, ASC09 and ASC06. As the State Food and Drug Administration granted the approval of a new drug application for Danoride on June 8, 2018, the company began commercializing Gonowei (Danolive). In addition, the company has not yet commercialized other products.
Gloria Pharmaceuticals will be the first biotech company listed in Hong Kong after the entry into force of the new listing of the Stock Exchange in 2018 and has no product sales revenue and no profit (the last two full fiscal years), which is a milestone. The revised Main Board Listing Rules of the Stock Exchange allow biotech companies that fail to pass the financial qualification test of the Main Board to go public and set a threshold of HK$1.5 billion. A biotechnology company is defined by the Stock Exchange as a company primarily engaged in the development, application or commercialization of biotechnology products.
Hong Kong Offer Shares: 22,414,000 (10%)
International Offer Shares: 201,723,000 (90%)
Over-allotment option: 33,620,000 (additional 15%)
Issue price: HK$12.0-16.0
Market capitalization: HK$134-179 billion
Board lot size: 1,000 shares
Tangible net assets per share after issuance: HK$2.87-3.64
Sponsor: Morgan Stanley Asia Limited, Goldman Sachs (Asia) LLC, China Merchants Securities (Hong Kong) Co., Ltd.
Underwriters: Morgan Stanley Asia Limited, Goldman Sachs (Asia) LLC, China Merchants Securities (Hong Kong) Limited
Callback mechanism: 15 times or less (not more than 20%); 15-50 times (30%); 50-100 times (40%); 100 times or more (50%)
Cornerstone Investor: GIC Private Limited ($75 million)
Prospectus: 2018/7/20 (Friday) to 2018/7/25 (Wednesday)
Pricing date: 2018/7/26 (Thursday)
Announcement of the distribution result: 2018/7/31 (Tuesday)
Listing transaction: 2018/8/1 (Wednesday)
In April 2013, a wholly-owned subsidiary, Ge Li Biotech, was established.
In April 2014, Danorwee was submitted to the National Drug Administration (CFDA) as an IND (new drug research application) for a new class of drugs in the country.
In April 2015, Lavidawi was submitted to CFDA as an IND application for a new class of drugs in the country.
From August to November 2015, the first round of financing was completed.
In September 2015, Danover was approved by the CFDA as an IND application for a new class of national drug.
In May 2016, Lavidawi was approved by the CFDA as an IND application for a new class of national drug.
From December 2016 to February 2017, the second round of financing was completed.
In December 2016, Gonowei (Danoliwei) R&D project was recognized as a national special science and technology major new drug; a special project was created.
In January 2017, DNA was approved as a national first-class drug for NDA (new drug application).
In September 2017, it won the first place in the medical innovation industry of the National Innovation and Entrepreneurship Competition jointly organized by the Ministry of Science and Technology, the Ministry of Finance, the Ministry of Education of China, the National Internet Information Office and the All-China Federation of Industry and Commerce.
In December 2017, the company's hepatitis C project was recognized as a national science and technology major project for the development of innovative drugs for hepatitis C.
In April 2018, the Phase II/III clinical trial of Ravidavir in China was completed.
In June 2018, Gonowi was approved by the State Food and Drug Administration to apply for a new drug as a new class of drugs, and began to sell Gonowei in China.
Schematic diagram of shareholding structure:
As a full-value chain anti-virus platform, Gloria Pharmaceuticals focuses on developing innovative, best-in-class anti-HCV, HIV and HBV drugs. The company currently has five antiviral drug discovery and development projects, three of which are HCV (Hepatitis C) treatment programs, one for HIV (AIDS) treatment programs and the other for HBV (Hepatitis B) treatment programs. In addition, the company has two projects focused on liver disease.
At present, the company has two kinds of hepatitis C research drugs at or near the commercial stage, one is in the clinical trial stage. The company's HIV research drug has completed phase IIa clinical trials, while liver cancer research drugs have completed phase I and phase I extended clinical trials. The following table is an overview of the company's product pipeline:
Hepatitis C research drug
The HCV genome is encoded by ten polyproteins, including three structural proteins and seven non-structural proteins. Among the above proteins, NS3/4A, NS5A and NSS5B are the only three effective targets for DAA (direct antiviral drugs). DAA inhibits the activity of these three different non-structural proteins to stop viral replication.
All three companies in the company are DAA, Gono is NS3/4A protease inhibitor, ravidasvir is NS5A inhibitor, and ASC21 is NS5B nucleotide polymerase inhibitor. With these three research drugs, the company plans to offer an interferon-containing DAA treatment regimen and two full oral treatment regimens: Gonovir treatment regimen (with interferon); RDV/DNV treatment regimen (all oral) ; RDV/ASC21 treatment regimen (all orally).
HIV research drugs
ASC09 has the potential to be the best-in-class protease inhibitor for HIV-like ("HIV-1") infection. ASC09 has an unprecedented genetic resistance barrier and has completed Phase I and Phase II clinical trials, showing effective antiviral activity. In phase IIa clinical trials, ASC09 reduced viral load by 1.79 log (62-fold reduction in viral load in patient blood samples). This clinical trial also showed that ASC09 is safe and well tolerated. ASC09 is expected to launch the IIb clinical trial in 2020.
Liver cancer research drug
RNA interference is a natural cellular mechanism that regulates gene expression and is mediated by small interfering RNAs ("siRNAs"). The company aims to develop ASC06 as the first systemic drug to treat liver cancer using RNA interference technology, with the aim of inhibiting two key genes for the growth and development of liver cancer cells, VEGF and KSP. ASC06 has completed phase I and phase I prolongation clinical trials in 41 patients and 7 patients, respectively. The results showed that 50% of patients receiving 0.7 mg/kg were nearly stable and one patient received a complete response. The ASC06 is safe and well tolerated. The company expects to launch phase II clinical trials of ASC06 in China in 2020.
The specialty of R&D Pharmaceuticals involves drug discovery and clinical development of antiviral drugs. The company's R&D team is comprised of experienced scientists from global pharmaceutical companies such as GSK and Roche. The company's internal R&D team consists of 33 members, divided into discovery teams, clinical development teams and regulatory teams. In 2016, 2017 and the first quarter of 2018, the company's research and development expenditure was RMB 62.7 million, RMB 114 million and RMB 22.8 million, respectively.
Since February 2016, the company has established a commercialization team to lay the foundation for the commercialization of the first products and to develop a targeted marketing strategy. The company has established a commercialization team of approximately 150 people covering more than 850 hospitals with the most extensive strategic position of hepatitis C in China. The commercial team's work includes approximately 5,500 experts and key opinion leaders in pre-market research and patient analysis, brand building, identification and education in the field of hepatitis. The company expects to sell its products to hospitals and other medical institutions, DTP pharmacies and other pharmacies through distributors or their sub-distributors, and is currently establishing a network of distributors and entering into distribution agreements with distributors.
According to the Frost & Sullivan Report, the market income of antiviral drugs in China in 2017 was RMB 26.2 billion. The antiviral drug market mainly includes anti-hepatitis B, anti-hepatitis C, and anti-AIDS drug markets. Hepatitis B, hepatitis C and AIDS are the major diseases of all viral diseases, accounting for about 80% of the 2017 antiviral market by sales.
In 2013-2017, the overall market for antiviral drugs grew steadily, with a compound annual growth rate of 10.9%. In the next decade, with the increasing popularity of innovative hepatitis C drugs in China and the rising treatment rate of hepatitis C patients, the Chinese antiviral drug market will grow steadily to 56.2 billion yuan in 2022 and 177 billion yuan in 2030. The compound annual growth rate for 2017-2022 is expected to be 16.5%, and the compound annual growth rate for 2022-2030 is expected to be 15.4%.
Hepatitis C is a widespread infectious liver disease caused by the hepatitis C virus. Common routes of transmission are unsafe medical procedures, the use of unsanitized medical equipment, and the delivery of unscreened blood and blood products. Hepatitis C is one of the major causes of chronic liver disease in China, including cirrhosis and liver cancer.
In 2017, the prevalence rate of hepatitis C in China was 1.82%, and an estimated 25.2 million people infected with hepatitis C. Due to the lack of awareness of the disease and the lack of breakthrough therapy, and the fact that most patients experience relatively few symptoms, the diagnostic rate of hepatitis C has been low. Due to the lack of effective anti-hepatitis C treatment, only about 74,000 patients were treated in the huge population of hepatitis C patients in 2017, with a treatment rate of only 0.3%.
During the performance period (2016, 2017 and the first quarter of 2018), as the company has not commercialized any products, there is no product sales revenue. The company's revenue during this period is derived from the instalments and upfront payments made with Roche, the world's leading pharmaceutical company, for the Gonowei licensing arrangement.
In April 2013, the company entered into an exclusive licensing agreement with Roosevelt for the development and manufacture and commercialization of several Roche trademarks and know-hows of Darnorwe in Greater China. The only and exclusive right. The company has the right to receive up to $31 million in phased payments from Roche, which has now received $26.5 million and has achieved milestones in obtaining the remaining milestone payments. The company agrees to pay a percentage of the united percentage of Ronald's net sales to any Roche payment in any and all treatment options in Greater China.
Advantages and prospects
1. The first commercial hepatitis C therapy developed by domestic companies - Gonowo.
2. The first complete oral and interferon-free hepatitis C treatment program developed by domestic companies has been completed - Lavidavir.
3. A strong R&D product pipeline with potential best-in-class research drugs.
Risk and crisis
1. The financial prospects for the coming years will largely depend on the successful sales of Gonower and the successful application and sales of Ravi Davi.
2. The anti-viral drug market is highly competitive, and new drugs are also facing competition from listed products or potential listed products of other treatment options.
3. New drugs face many uncertainties in the process of R&D, approval, production and sales. Any process that is not smooth may result in lower than expected development results.
Company Name Songli Pharmaceutical Co., Ltd.
Time to market 2018-08-01
Official website http://www.ascletis.com/
Chairman of the Board Wu Jinwei
Chief Executive Officer Wu Jinwei
Hong Kong Stock Exchange
Address: 18th Floor, Building 4, Shuangcheng International, 1785 Jianghan Road, Binjiang District, Hangzhou, Zhejiang, China
The largest shareholder Wu Jinwei