Yifan Pharmaceuticals: Successful layout of bio-innovative pharmaceutical platform, the investment value of the time?

Introduction: "Traditional pharmaceutical enterprises" billion sail medicine stereotypes change! Recently, the planet's circle of friends has ignited interest in Yifan Medicine, the main reason is nothing more than the subsidiary Kenenglong Sino-American double report of the large-molecule biopharmaceutical F-627 in clinical phase III success, and F-627 is the second after Baiji Shenzhou Zebtini Head-to-head research through the FDA, this suddenly changed the market investors for the "traditional pharmaceutical companies" Yifan pharmaceutical valuation logic considerations and stereotypes, for the company opened up a greater valuation space, this article specifically expounded the value of Yifan's innovative pharmaceutical modules, as well as the decomposition of its traditional plate.
1, billion sails of the journey, the company's various business sectors decomposition 1, Cheng boss's "point gold hand": the traditional pharmaceutical companies of the road to change the way Yifan medicine can go to today, the credit must be Cheng boss.
the development course of the company, Cheng boss led yifan made three important decisions on the rhythm, these decisions also achieved the current billion sail, can be seen in its profound strategic vision and excellent management level.
- The first stage - drug distribution and agency service providers expanded into an integrated platform for drug production, agency and sales; Stage - the acquisition of new drug platform Jiannenglong, from traditional pharmaceutical companies to "bio-innovative pharmaceutical enterprises" transformation and upgrading here inserted a small episode, in a billion sails of investor exchanges, a 70-year-old man said he re-positioned billions of sails, trust the company.
Always stand up and seriously really bow to the elderly, the stock price will certainly have market fluctuations, but business operations please rest assured that an excellent entrepreneurial style is evident.
2, Yifan's business sector dismantling experienced a series of mergers and acquisitions operations, Yifan Pharmaceutical's business across a number of areas, including shell-listed successors of the original Xinfu Pharmaceuticals API business (mainly calcium pan-acid) and polymer materials business (mainly PBS, a biodegradable material), as well as its own pharmaceutical products business.
From the gross margin data and revenue distribution can be seen, although the pharmaceutical products business accounted for 70% of the company's main business, but for the company's overall gross profit contribution efficiency is much lower than the API business, it can be clearly seen that Yifan's original pharmaceutical circulation, the exclusive agent drug business represented by the pharmaceutical services business gross margin contribution is low.
In addition, the pharmaceutical products business has acquired some companies since the listing of shell products, the most important is shenyang-based therapeutic large infusion, orthopaedic drugs, Sichuan-based gynecology, dermatology, pediatric drugs, as well as Anhui-based plant drugs, oral solids drugs.
final pharmaceutical products business left us most focused on the innovative pharmaceutical business, has not yet produced a performance contribution.
according to the latest company disclosure data, a total of 67 projects are currently under development, of which 10 biological drugs, 39 chemical drugs (of which 8 are consistent evaluation), 12 Chinese medicine and 6 vitamin products.
However, based on the above data, basically for everyone to draw a focus, billion sail biological point of view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
II, dual anti-platform power hand F-627, F-652 two heavy-weight products our much-watched F-627 bio-molecular innovation drug originated from the core subsidiary Kenon Lung Bio, currently through Yifan Hong Kong holds a 62.04% stake in Kenlong Bio.
JiannengLong Bio (now renamed Evivebiotech) is the leading bio-innovative pharmaceutical research and development enterprise in China, and is the first Chinese company to complete the independent research and development of bio-innovative drugs in the global clinical phase III research.
is the core value of Jian Jianlong embodied? There are about three points: 1, the scarce dual anti-technology platform: bio-molecular innovation drug "egg hen" antibody drug is the largest class of biological drugs, people have invested a lot of resources, optimistic about the future of this field.
competition for single-resistance tracks, only three dual-anti-drugs have been approved worldwide: Trion's Catumaxomab, Amgen's Blinatumomab and Roche's Emicizumab.
statistics, the success rate of clinical development of a new type of dual anti-drug is similar to that of bio-innovative drug development (or 20%), which shows how difficult its technology is.
addition, the global market size of dual-specific antibodies is expected to reach $8 billion by 2025, growing very fast, a sea of blue.
So, dual-specific antibodies are also known as the second generation of tumor therapy antibodies, there are currently more than 39 kinds of monoantigen drugs have been certified by the relevant institutions and applied to clinical anti-tumor treatment, but also made breakthrough therapeutic progress, but still a large proportion of patients should not answer the drug resistance.
dual-specific antibodies can bind to two targeted bits, one is the tumor antigen on the surface of the tumor cell, the other is the antigen on the surface of the immune cell, such as T cells, NK cells, etc., the most important of which is the collection of T cells.
, it is worth noting that dual resistance does not exist in a natural state and needs to be prepared manually by techniques such as DNA recombination or cell fusion.
the corresponding dual-anti-design platform is the most important, Amgen adopted Bite is currently the most mature application of one.
some domestic enterprises are also actively layout dual anti-business, the most representative platform is the energy-boosting iTAB immunoantibodies platform, as well as You chiyou's Ybody, Corning Jerry's CRIB and shore-based organisms FIT-Ig.
Jianneng Lung Bio has a domestic scarce international first-class DiKine dual molecular platform and iTAB immunoantibodies platform, undoubtedly laid the company's long-term original innovation capabilities.
2, pipeline reserves are sufficient, holding two near-commercial heavy-weight products: F-627, F-652 Kenon Lung Bio has a strong competitive bio-innovative drug pipeline, F-627, F-652 is currently the two closest to commercialization of the two varieties, the other two dual anti-pipeline A-337, A-319 is carrying out clinical phase I research.
(1) F-627: Bestinclass whitening agent, head-to-head KO into Neulasta whitening agent is what drug? At present, chemotherapy is one of the most common and effective means to treat cancer, but because chemotherapy is a non-differentiated attack on human cells, chemotherapy in general will lead to insufficient blood cell supplementation in human blood.
and white blood cells survive for the shortest amount of time, from a few hours to a few days (different types), so chemotherapy has the most severe effect on white blood cells! There are three main functions of white blood cells, the defense of the body by microorganisms, to prevent internal cell rebellion and the removal of apoptotic cells and metabolites, if after chemotherapy white blood cells reduced to a certain extent and can not be replenished in time to restore, it is easy to make cancer patients infected with the body, thereby endangering life.
Clinically, recombinant human granulocyte collection stimulation factors ("white needle", rhG-CSF) are often chosen to reduce the rate of infection caused by reduced fever-causing neutral granulocytes in patients, simply by "pushing" bone marrow to make white blood cells.
there are currently two generations of recombinant human granulocyte cluster stimulation factors ("white needle", rhG-CSF) on the market, both of which are Neupogen and Neulasta.
what is a head-to-head trial (as compared to the efficacy of the original drug)? Where's the F-627? The F-627 trial in Phase III was compared with Amgen's original drug, short-acting Neupogen, and long-acting Neulasta, and the results show that it has shown a better effect than Neulasta (as shown by lower infection rates, shorter durations of stage 4 anemia, and more effective for patients with poor health), so the F-627 is different from several Neulasta biosupergens listed in the United States.
's Neulasta currently has three major problems, one is that some patients do not respond, two is 7% of patients will have allergic reactions, not hospitalized treatment may not be the way to use Neulasta;
the F-627 will be the only alternative to Neulasta when it companies go public.
the F-627 have a chance to capture much of the market? The global market for chemotherapy-induced neutral granulocyte reduction drugs is about $7 billion, and less than 15% of patients are using second-generation long-acting rhG-CSF, and there is a lot of room for improvement in long-acting rhG-CSF dosing.
's Neulasta peaked at $4,715 million in 2015, with the U.S. market accounting for a relatively high share of global sales of 75-85 percent.
F-627 as a Sino-AMERICAN dual-report product, the future can be sold worldwide.
and the main consideration is still in the U.S., the Chinese market is second.
Based on open source securities projections, the F-627 is expected to peak at $354-531 million in the U.S. market at 90 percent of Neulasta's price, based on sales of $3,931 million in 2017 and a conservative market share of 10-15 percent.
's sales in China are expected to peak at 1,553 million yuan (15% market share, 1.5W per capita for treatment), a large variety with a high probability of more than $8-1 billion in revenue from markets other than China and the U.S.
(2) F-652: Acute Graft Anti-Host Disease Firstinclass Drug, exclusive market segment In addition to F-627, F-652 is the next heavy original biological new drug to be commercialized.
F-652 is a recombinant human interleulin 22-Fc fusion protein, with IL-22 bimolear structure, the main role is tissue protection and repair, the current two main adaptive disorders for acute graft anti-host disease and alcoholic hepatitis.
: Acute Graft Anti-Host Disease (GVHD): Simply put, the clinical symptoms of damage to the body caused by the immune cells of transplanted organs after an organ transplant.
cytotoxic attacks on the target cells, with the skin, liver and intestines being the main targets.
of acute graft anti-host disease was 30% to 45%, and the rate of chronic disease was lower than that of acute.
it is worth noting that acute graft anti-host disease is an important cause of death of long-term survivors after hematopoietic stem cell transplantation, and also a major factor affecting the quality of life of patients.
: New targets, few competitors: IL-22 should now be a brand new target, the only competitor of the current target billion sail is Genentech, unlike Yifan to do acute disease, Genentech is doing chronic diseases, is IBD and diabetes.
the progress of hundreds of millions of sails slightly ahead of Genentech, Genentech clinical now 2a phase in the group, 100 million sails 2a phase completed.
for IL-22 targets, there are many adaptations and many cases of adaptation.
and Genentech are not competing in the short term, but are being handled in different directions.
. What's the market space: There are currently 25,000 transplant-resistant host patients in the U.S., 20,000 of whom are acute, about 3,000 new each year, and about 40% of patients with liver or gastrointestinal damage need F-1s. 652 treatment, according to the penetration rate of 60%, market share of 20%, the annual cost of traditional transplant anti-host treatment of $60,000 a course, then F-652 sales in GVHD peak of about $167 million.
There are currently 445,000 people with alcoholic hepatitis in the United States, an annual growth rate of 3%, 60% will be treated with drugs, the annual cost of traditional treatment of alcoholic hepatitis a course of 20,000 U.S. dollars, according to the penetration rate of 50%, the market share of 25%, then F-652 sales of alcoholic hepatitis peaked at 534 million U.S. dollars.
3, mature CMC department: for the follow-up new drug declaration production escort biological drug research and development success is difficult that THEC development is mainly due to biological drugs involved in living cells or bio-expression protein-like large molecules, protein structural stability control than chemical drugs need more exquisite technology.
Jianneng Long set up a dedicated CMC department, with a complete set of biological drug development technology strength.
's CMC development team has advanced and rich experience in biopharmaceutical development and biopharmaceutical declaration at home and abroad.
is expected to open up China's declaration and production channels in the field of biopharmaceus technology under global standards through the establishment of a high-quality and efficient process technology platform for the production of recombinant protein preparations for therapeutic use in mammalian cells and the commercialization of the first Chinese bio-innovative drug F-627 declared in the United States.
three blood transfusion innovative drugs of cows: pan-calcium pan-acid business Yifan medicine in the market, unlock a series of buy-to-buy operations, the original Xinfu Pharmaceuticals pan-calcium pan-acid API business is indispensable.
From the 2015-2019 revenue growth of the three major business sectors, it can be said that the compound growth rate of pharmaceutical products and API business is not the same, but the growth of pharmaceutical products thanks to a series of mergers and acquisitions, gold content is not as small as the API business.
can be said that the API business is still the most stable, the most important source of profits.
1. The supply relationship is stable, and the global demand for calcium panate in 2019 is about 20,000 tons, 70% for animal feed, 30% for cosmetics and medical care, the main demand is from abroad (80%).
Because of the important role of raw materials such as calcium panate in promoting the use of nutrients, promoting the synthesis and decomposition of fatty acids, there are no competitive alternative products, and the demand supply structure is stable.
2018 statistics, the global production capacity of calcium pan-acid is about 27,000 tons, of which the domestic production capacity is about 22,000 tons, pricing power in the hands of domestic enterprises.
foreign manufacturers are mainly DSM and BASF, with a production capacity of 2500 tons.
domestic Yifan Xin rich production capacity of the highest, 8000 tons, accounting for 35% of the global production capacity, well-deserved global leader.
200 million sails.