The gold standard for innovative pharmaceutical companies to survive

China's emerging biotechnology industry has entered an era of

Now, Hong Kong stock pharmaceuticals are showing a positive sign, the stock price performance is significantly differentiated, no longer the previous overall bubble or the overall killing of the situation, which shows that the beginning of the gradual departure from the beta market, the company's internal alpha can be reflected

It's also in line with the law of cognition, a new thing, from collective fanaticism to collective disappointment, and then back to rationality, and stock prices are driven

What are the fundamentals or gold standards for a good biotech company? Pipelines address the unmet clinical needs of patients in China and around the world, and are capable of original innovation and, in short, the ability to continuously export original, high-value new drugs

Orebatinib, the domestic small molecule innovative drug king Yasheng Pharmaceutical, is a representative of the original high-value new drug, with differentiated advantages and pricing power, which is enough to solve the two major pain points of domestic innovative drugs - internal rolling and payment ability

The era of differentiation of innovative drugs means entering the normal ecology of survival of the fittest, there are fallouts and breakthroughs, there are sinking and rising, we should not only stare at the negative and pessimistic, but also see the positive side and walk

Yasheng Pharmaceutical is in research varieties According to the semi-annual report

01 One of the strongest self-research capabilities

Biotech used to face multiple options for

The license-in model is an important way for traditional pharmaceutical companies with advantages in commercial channels to maintain the advanced nature of pipelines and expand commercial capabilities, and Fosun Pharma, Huadong Pharma, CSPC Pharmaceutical Group, and China Biopharmaceuticals have all had successful cases

For Biotech, which has thin business resources, the license-in model is similar to the real estate business

The valuation of real estate stocks is not high, one reason is the high leverage of

R&D Biotech is the mainstream of

After the expansion of the commercialization team, the proportion of R&D personnel in the total number of employees is still as high as 70%, of which 67 have doctoral degrees

During the market ice age, almost all 18A companies focused more on cash reserves

We can be more optimistic

Asunyapea's first commercial product, orebatinib, leveraged sales revenue of 95.

In the absence of medical insurance for the time being, this business achievement is beyond expectations
.

Complete interpretation of the logic
of original high-value new drugs.

In the past, slow-grain leukemia (CML)-resistant patients carrying the T315I mutation could only buy punatinib, which was not listed in China, from overseas, which sold for about HK$80,000 per box and was at risk
of "life-threatening thrombosis and severe stenosis of blood vessels".
Some patients are forced to buy cheap generic drugs produced by The Everest Pharmaceutical Factory in Bangladesh online, which has the risk of illegal drug purchase and drug safety hazards
.

Erebatinib has better safety and becomes the white knight who saves these patients, is the first and only third-generation BCR-ABL inhibitor approved for marketing in China, has the best in class potential in the world, and can fill the global clinical gap
.

Greater business value is being unlocked
.

Listing applications for orepatinib for the treatment of first- and second-generation TKI-resistant and/or intolerant CMLs were accepted by the CDE and included in the priority review, which is expected to accelerate the benefit of more and wider domestic CML patients
.

Explore areas beyond the tumors of the blood
.
At the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO), Axason Pharmaceuticals announced the clinical progress of orebatinib for patients with gastrointestinal stromal tumor (GIST), showing good anti-tumor activity, with a clinical benefit rate (CBR) of up to 83.
3%.

Orebatinib also has the potential to treat novel coronavirus pneumonia (COVID-19), especially in patients with moderate to severe disease, and the results have been published
in EMBO Molecular Medicine, a top journal of the European Molecular Biology Organization (EMBO).

Advance clinical development
at a global level.
Orepatinib is licensed for a Health Canada clinical trial to conduct a Phase IB clinical study
treating patients with drug-resistant CML and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
At present, orebatinib is conducting bridging experiments in the United States, and it is expected to disclose the relevant progress
by the end of this year.

Promote market development
at a global level.
Asun Pharma and multinational drug supplier Tanner Pharma launched the Designated Patient Drug Use Program (NPP), similar to Hainan's Boao model, to help orebatinib provide drug opportunities for designated patients in areas where marketing authorization has not yet been granted, covering more than 130 countries and regions, benefiting many patients
with no drug treatment around the world.

Through the NPP innovation model, orebatinib can achieve rapid going to sea, because of the clinical value advantage, overseas pricing is higher than punatinib, harvesting an easter egg
in the incremental market.

With its strong R&D capabilities and business strategies, Yasheng Pharmaceutical has successfully changed the market expectations of orebatinib, turning from a niche drug to a large single product
.

03 The next one is heavier

APG-2575 is considered to be one of the most important domestic innovative drugs, and the benchmark Abbvie Venetoclax has the highest attention
in the Yasheng Pharmaceutical pipeline.

As the world's first approved Bcl-2 inhibitor, Venetoclax has global sales of $1.
82 billion in 2021 and is expected to peak sales of up to $6 billion in the future, but has serious side effects
of tumor lysis syndrome (TLS) and cytopenia.
APG-2575 is the first indigenously developed Bcl-2 selective inhibitor to enter clinical trials in China and the second Bcl-2 selective inhibitor in the world to enter a registered clinical study, with well tolerated, controllable adverse events and a very low
risk of tumor lysis syndrome (TLS).

Broad-spectrum anti-cancer variety, covering a wide range of indications, including chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), acute myeloid leukemia (AML), multiple myeloma (MM), Fahrenheit macroglobulinemia (WM), solid tumor, is conducting 19 Phase Ib/II clinical studies
in China, the United States, Australia and Europe.

Multiple results further confirm that APG-2575 has best-in-class potential
worldwide.

It is expected that the relevant data of the combination akatinib treatment relapse/refractory CLL/SLL will be disclosed by the end of this year, and the key registration Phase II clinical enrollment
of the treatment relapse/refractory CLL/SLL is expected to be completed in the first half of next year.

In the explosive echelon of Asunyapea, APG-115 is the first MDM2-p53 small molecule inhibitor to enter the clinical stage in China, and APG-2449 is the first indigenous primary research third-generation ALK inhibitor
to enter the clinical stage.
Special attention is paid today on two other new concept drugs
.

Embryonic EctodermAl Development Protein (EED): APG-5918 is the first Chinese original research EED inhibitor to enter the clinical stage, licensed by the FDA for clinical trials, will carry out the first human clinical trial to explore the safety, pharmacokinetics and efficacy of the treatment of advanced solid tumors or hematologic malignancies, and the IND application in China has also been submitted and accepted
by the CDE.
In the near future, it also plans to submit an IND application for the treatment of anemia to the CDE
.

Anti-aging drugs: This is a little-known past, Yasheng Pharmaceutical has gone to sea as early as 2016, authorizing Unity to develop UMX1325 (an anti-aging Bcl-xL inhibitor) and retaining Chinese interests
。 On August 12 of this year, Unity's stock price soared by 54%, and the results of the Phase II BEHOLD study of UBX1325 for the treatment of diabetic macular edema (DME) showed that after a single injection, patients' vision and retinal improvements could be maintained for up to 18 weeks, which is statistically significant, and is expected to bring a new drug that can replace all existing therapies, including standard anti-VEGF drugs
, for DME patients.

There is no gimmick, the sun arches a pawn, Yasheng Pharmaceutical gives people a sense of calm in making medicine steadily, in fact, this company is very personality, no license-in, and the popular fast-follow, me-too is also completely different
.

Homogenization robs the low-hanging fruit, and differentiated innovation is destined to belong to the slow-heat type, but it has stood at the forefront
from the beginning.