Shiya Pharmaceutical (01093) has Enbipu (butylphthalide), Sansheng Pharmaceutical (01530) has "Tebio" (recombinant human thrombocytopenin injection), Dongyangguang Pharmaceutical (01558) has "Kewei" (oseltamivir phosphate)... All pharmaceutical companies have all lived a "comfortable" petty bourgeois life because they hold a "magical medicine" in their hands.
Similarly, small-cap Liankang Biologics (00690) has also attracted much attention from the market in recent years because of its "magic medicine" - "Jinyin Peptide" and "Jinyinshu". After all, the former won all the bids except Zhejiang, Fujian and Qinghai, and also entered the military coordination for the entire army, for procurement by seven major military regions or troops; the latter won all the bids except Henan, Zhejiang and Anhui, and also entered the military coordination for procurement by six major military regions or troops. With such a wide coverage, why worry about not being "remembered" by the medicine circle.
Thanks to this, Zhitong Finance APP observed that in the past 11 transactions, the stock took advantage of the pullback of the pharmaceutical sector, with an increase of about 7 points and a transaction of 24.067 million shares. Although there is no obvious increase in volume, from another perspective, it is enough to show that its investors are firmly holding on.
Market Source: Futu Securities
In addition to the new changes in the stock price, Liankang Bio, which holds two "magic drugs", seems not willing to only enjoy the current results. Instead, it has stepped up the research and development and investment of new drugs in order to quickly have its third "magic drug" - Teripatide.
The osteoporosis market continues to expand
As a pharmaceutical investor, there is a logic: "Buy big but not small", that is, to enter the fields of major diseases and tumors. Because these fields are basically industries that are extremely prone to heavy varieties of billions and billions, and once they are accurate, the market return rate is amazing. For example, the original form of "glenin" in " I am not a medicine god " - imatinib .
Novartis launched the drug in 2001, exceeding $1 billion in just three years. It has continued to grow since then and reached its peak of $4.6 billion in 2011. It was not until 2015 that the patent protection of imatinib was fully expired, and the sales share of generic drugs hit the impact of the company. This is also one of the main motivations for biomedical pharmaceutical companies to invest heavily in new drug research and development in recent years.
Compared with anti-cancer drugs, sales of more than 1 billion US dollars, Zhitong Finance APP found that there are actually many major diseases that have the potential in the fields of serious illness, such as metabolic disease caused by multiple complex factors such as osteoporosis .
Not to mention the distant nature, the total prevalence of osteoporosis in China alone is as high as 12.4%, second only to circulatory diseases. A large-scale epidemiological survey and research nationwide showed that the total number of people suffering from osteoporosis in China has exceeded 160 million. It is predicted that by 2020, the number of patients with osteoporosis and low bone mass in my country will increase to 280 million, ranking first in the world.
In fact, the reason why my country has become the world's largest country in osteoporosis is mainly because it is related to our dietary calcium intake. The "Global Dietary Calcium Intake Interactive Map" released by the International Osteoporosis Foundation recently showed that among the 74 countries and regions with data, mainland Chinese residents ranked sixth from the bottom intake of daily dietary calcium intake, less than half of the recommended amount.
China is still the case, and it is conceivable that the number of patients around the world is undoubtedly greater. Based on this, on November 26, 2002, Eli Lilly, who had devoted himself to researching in the field of osteoporosis for many years, finally brought the world's first bone formation promoter and peptide drug, teriparatide, to the US market; half a year later, it was approved by the European EMA. After trekking along the way, by 2009, Teripatide had strongly entered the TOP200 US drug sales data, ranking 120 on the list with sales of US$507 million.
On July 23, 2010, Eli Lilly brought it to Japan, and allowed Asian osteoporosis patients to enjoy bone formation promoters; on March 4, 2011, teriparatide was approved for marketing by the Chinese CFDA and was sold exclusively by Eli Lilly. The product names are Forteo and Forsteo.
After four years of cultivation in the Chinese market, in 2015, the global sales of teriparatide reached about US$1.348 billion; in 2017, due to the wholesaler retail model adopted in the US market, teriparatide increased in both volume and price, with sales of approximately US$1.749 billion, an increase of 17% from 2016, becoming the top five flagship products of Eli Lilly.
It has to be said that the explosive power of products in the field of major diseases is also not inferior to that of anti-cancer drugs.
Liankang became a strong competitor of teriparatide
Although teriparatide achieved sales of nearly US$1.8 billion in just one year, Zhitong Finance APP learned that 2014-2019 is the peak period for patent expiration of blockbuster polypeptide drugs, among which Eli Lilly's teriparatide will lose patent protection in December 2018.
Simply understand, sales of US$1.8 billion is its highest sales peak. Because after the patent expires, in the context of the aging of the global population and the sharp increase in the number of people with osteoporosis in the global population, other generic drug companies will definitely not miss this opportunity, and will even make arrangements in advance.
For example, Amgen and Pfenex in the US stock market, Xinlitai in the A-share market, Hanyu Pharmaceuticals, Liankang Biologics in the Hong Kong stock market, and unlisted United Sail Company will undoubtedly put pressure on Eli Lilly.
Take Pfenex as an example. Its PF708 and the original teriparatide were used for head-to-head experiments. The two selected 90 (PF708) and 91 (teriparatide) patients for clinical trials respectively. Among them, 82 patients in the PF708 treatment group completed the study, and 81 patients in the teripatide treatment group completed the study. Based on the clinical data effect, PF708 is significantly better than teriparatide. Because of the obvious effect, Pfenex will also submit a new drug application to the FDA in the third quarter of 2018, and is expected to be launched in the third quarter of 2019.
Similarly, A-share Xinlitai is also at the forefront. In November 2017, the listing application for "Terripatide for injection" (recombinant human parathyroid hormone 1-34 (rhPTH1-34) freeze-dried powder injection) developed by the company's subsidiary Suzhou Jinmeng and Chengdu Jinkai was accepted by the CFDA (CXSS1700023).
Compared with the fierce "competition competition" of US stocks and A-shares, only Liankang Bio has entered the research and development field of teripatide in the Hong Kong stock market, becoming the only target among H-shares.
CFDA data shows that the company's Uni-PTH is currently in the NDA submission stage, and the data is also better than Eli Lilly's teripatide. In terms of dosage form of , Liankang Bio not only has freeze-dried powder, but also innovatively upgrades to make the freeze-dried powder directly turn into a water needle, which is more convenient to use. Among them, the dosage form of the lyophilized powder injection is expected to be launched as early as 2019. If the plan goes well, you can compete with Pfenex in time and become the second company in China to launch such products.
, which also means that Uni-PTH can bring huge benefits to Liankang Bio. Based on the current market and Eli Lilly data comparison, from 2020 to 2022, Uni-PTH's sales are expected to achieve 2.88 million yuan, 4.82 million yuan and 8.09 million yuan respectively, with a three-year compound growth rate of about 68%.
other R&D pipelines are worth paying attention to
In addition to Uni-PTH, another highlight of Liankang Bio's R&D pipeline is in the field of diabetes , including acarbose , GLP-1 inducer E4, human erythropoietin EPO-Fc, etc.
First talk about acarbose. On June 5, the company announced that it had announced that "the wholly-owned subsidiary Beijing Bokangjian Gene and Beijing Baiao entered into an agreement on joint development and marketing of acarbose tablets." This is also the first implementation project in the signing of a joint development agreement with Beijing Sunshine Nuohe in December 2016.
data shows that in 2016, the market size of acarbose terminals of public medical institutions in China was 6.247 billion yuan, an increase of 6.95% year-on-year, which shows the huge market size of this drug in China. Currently, there are not many competitors in China. Liankang Bio has undoubtedly an advantage when entering this time. Moreover, the company's acarbose tablets have completed the pharmaceutical stage research work. They will start human bioequivalence research in the near future, leading the progress of the same variety of projects under research, and are expected to become the first batch of manufacturers to apply for production approval documents.
Let’s talk about E4. This product is a GLP-1 inducer, which is an independent innovative drug for the treatment of type II diabetes. The dosage form is divided into lyophilized powder and water injection.Up to now, the freeze-dried powder injection has completed the third phase of clinical trials; the water injection is actively doing BE. After passing, the Phase III clinical trials can be initiated immediately according to the new rules of the CDE exchange meeting. Due to the unique therapeutic effect of E4, once it is launched, it is expected to set a new high, and it is expected to achieve sales of 12.5 million yuan in 2021.
Finally, EPO-Fc is mentioned. This product is a glycoprotein hormone that promotes the maturation of red blood cells. As a long-acting EPO treatment method, EPO-Fc has greatly improved the treatment convenience for patients suffering from anemia and chronic kidney disease. The EPO-Fc market has a rapid growth trend around the world, but from the perspective of R&D, Liankang Bio is likely to become one of the earliest providers in China to supply long-acting Uni-EPO-Fc products, and its sales are expected to reach 293 million yuan in 2024.
integrates the teripatide market, as well as Liankang Bio's leading position in this field, the action of R&D pipelines such as diabetes, and combined with existing sales capabilities, the company's prospects are undoubtedly very optimistic.
(WeChat ID: UniBio-IR)
