Yasheng Pharmaceutical announced its 2022 interim results: the commercialization of Nerick ® has accelerated, and the key pipeline varieties have gradually entered the harvest period

Suzhou, China and Rockville, Maryland, USA, 27 August 2022 /PRNewswire/ -- AsiaPharma, a leading biopharmaceutical company dedicated to developing innovative drugs in therapeutic areas such as oncology, hepatitis B and aging-related diseases, today announced its interim results
for 2022.

During the reporting period, the company's cash flow continued to improve and remained stable
.

The commercialization of Nerik ® has accelerated, and the clinical potential has continued to be tapped

As the first and only approved drug in China to be listed for the treatment of chronic myeloid leukemia (CML) with T315I mutation, the core products of Yasheng Pharmaceutical, the original Class 1 new drug, and the special achievements of the national "major new drug creation" have filled the domestic clinical gap and broken the survival dilemma of patients with T315I mutation CML resistance that had no drug to be treated, which is of ® great value
.

At present, Yasheng Pharmaceutical has successfully established a commercial team with rich experience in the field of hematology and oncology, and has cooperated with Cinda Bio to jointly promote
the commercialization of Nerick ® in the domestic oncology field.

It is worth noting that the company has joined hands with Tanner Pharma, a service provider that provides professional drug supply solutions for global pharmaceutical companies, to launch the Designated Patient Program (NPP), which is similar to Hainan's Boao model
.

In July, Neurik's ® listing application was accepted by the Drug Evaluation Center (CDE) of the State Drug Administration (NMPA) of China and included in the priority review process for the treatment of patients with chronic myeloid leukemia (CML-CP) who are resistant to first- and second-generation tyrosine kinase inhibitors (TKIs) and/or intolerance, which will support the full approval of
Narrick ®.

At present, Yasheng Pharmaceutical is actively promoting the clinical development
of Nerick ® at the global level.

In addition to the field of hematological oncology, the exploration of other fields by Neurik ® is also advancing
rapidly.

In addition, in the latest preclinical study of Neurik ®, it was also found that this variety has the potential
to treat patients with novel coronavirus pneumonia (COVID-19), especially in moderate to severe cases.

Related studies have demonstrated the ® potential for excellence in different therapeutic areas and fully demonstrated its differentiated clinical value
.

Adhere to the global innovation strategy layout and lead the frontier track

In the first half of 2022, Yasheng Pharmaceutical's investment in innovation continued to increase, with R&D expenditure of about RMB341 million, an increase of 7.

During the reporting period, the clinical development of the varieties under research of Yasheng Pharmaceutical has advanced rapidly, and the multi-field echelon pipeline is full of
power.

Under the guidance of the global innovation strategy, Yasheng Pharmaceutical has obtained 2 fast-track and 2 pediatric rare disease qualification certifications granted by the US FDA, and has also obtained 16 US FDA and EU orphan drug qualification certifications, continuously setting the innovation record of Chinese pharmaceutical companies and highlighting the company's outstanding global innovation ability
.

The clinical value is obviously differentiated, and it gradually enters the harvest period

As one of the companies that focus on original innovation and are at the forefront of the research and development of new drugs for apoptosis pathways, the clinical research progress of many varieties under research of Yasheng Pharmaceutical is remarkable, and it has frequently appeared at international academic conferences, fully demonstrating the company's research and development strength and clinical development level in the field of tumor treatment, and further verifying the potential
of multiple varieties of "first-in-class" and "best-in-class".

As the first locally developed Bcl-2 selective inhibitor to enter the clinical stage in China, APG-2575, an important variety of the company's apoptosis pipeline, is a key registered Phase II clinical study for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), which was approved by the New Drug Evaluation Center (CDE) of the State Drug Administration of China (NMPA) at the end of 2021 and completed the first patient administration in March 2022.

During the reporting period, Yasheng Pharmaceutical published clinical data on APG-2575 in R/R CLL/SLL patients in China at the ASCO Annual Meeting, with an objective response rate (ORR) of 67.

At the same time, the company presented the Phase I clinical trial data of APG-2575 in the
treatment of relapsed/refractory non-Hodgkin lymphoma (r/r NHL) in China at the 2022 European Hematology Association (EHA) Annual Meeting.
The data showed that it was still well tolerated at the dose climb to 800 mg/day, no TLS was observed, and showed initial efficacy in a variety of recurrent refractory hematological tumors, including CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and T-cell NHL, further validating its clinical development potential
。 Among the 11 patients with assessable CLL (all patients have received severe treatment including immunochemotherapy, BTK inhibitors, etc.
in the early stage, and the vast majority of patients have at least one high-risk prognostic factor including 17p deletion/TP53 mutation and/or others), 8 patients in the dose group of 200 mg (inclusive) can be evaluated, with an ORR of 87.
5%, 3 complete remission (CR), 4 partial remission (PR).

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

In addition, at the 2022 ASCO Annual Meeting, Yasheng Pharmaceutical announced the latest clinical progress
in the combination of the company's apoptosis pipeline, MDM2-p53 inhibitor APG-115, and pabolivizumab.
The data showed that the combination further validated antitumor efficacy in patients with melanoma who were resistant to tumor immunity (I-O) drugs or relapsed, including two cases of CR as well as 11% ORR and 57% disease control rate (DCR
).
At the same time, this combination therapy can achieve a positive clinical benefit in patients with malignant peripheral neural tenosyncelenoma (MPNST), with a DCR of up to 50%.

MPNST is a rare disease in children and there are currently no effective treatment options
.
This clinical progress provides a clinical basis for the synergistic effect between MDM2-p53 inhibitors and existing immuno-oncology drugs, with first-in-class potential
.

At the 2022 ASCO Annual Meeting, the company also announced for the first time the progress
of Phase I clinical trials of Akena Innovative Drugs, novel FAK inhibitors and third-generation ALK/ROS1 tyrosine kinase inhibitors (TKI) APG-2449 for the treatment of patients with second-generation TKI-resistant ALK/ROS1+ non-small cell lung cancer (NSCLC) and malignant mesothelioma 。 This clinical data showed that APG-2449 observed 4 PR cases in 14 patients with second-generation TKI treatment-resistant ALK-positive NSCLC; In 10 patients with initial ALK/ROS1 positive, ORR reached 80% and DCR was 100%.

APG-2449 is the first third-generation ALK inhibitor
to enter the clinical stage.
This clinical advance further demonstrates the company's development strength
in the field of solid tumor treatment.

Dr.
Yang Dajun, Chairman and CEO of Yasheng Pharmaceutical, said: "In the first half of 2022, despite the challenges of the epidemic, Yasheng Pharmaceutical has made outstanding progress
in commercial layout and clinical development.
In particular, the rapid commercialization of China's first and only third-generation BCR-ABL inhibitor Nerik ® after its approval to go public has made a positive contribution
to the company's revenue growth.
The continuous and steady cash flow also lays a solid foundation
for the company's subsequent operations.

At the same time as the rapid commercialization of Ninecr ® in China, we have launched the NPP program at the global level, providing the opportunity for patients in areas where Knight ® has not yet obtained marketing authorization to use the drug, accelerating the need to meet the needs of patients in urgent clinical need around the
world.
This project both revalidates the differentiation of Nirik's ® clinical value and precedes our global commercialization
.
Pleasantly surprised, we also found the preclinical potential of NRIK ® in treating COVID-19 indications, which also motivates us to continue to accelerate development
.
"

Under the guidance of global innovation strategy, Knight ®, APG-2575, APG-115, APG-2449 and other varieties have fully demonstrated the latest R&D achievements and clinical strength at major international academic conferences such as ASCO this year such as ASCO and EHA, AACR, further verifying the product value and clinical advantages of our rich product pipeline, and gradually entering the harvest period
.

As an enterprise focusing on original innovation, we will actively promote the excavation of its new indications and the promotion of overseas clinical practice while improving the accessibility of Nirik ®, while continuing to accelerate the clinical development of the varieties under research in the world, adhere to the global innovation positioning, and practice the mission of 'solving the unmet clinical needs of patients in China and even the world', benefiting patients around the world as soon as possible, while also creating more value
for shareholders.
" "

About Yasheng Medicine

Yasheng Pharmaceutical is a China-based, global biopharmaceutical company dedicated to the development of innovative drugs
in the therapeutic fields of oncology, hepatitis B and aging-related diseases.
On October 28, 2019, Yasheng Pharmaceutical was listed on the main board of the Hong Kong Stock Exchange with stock code: 6855.
HK
。

Yasheng Pharmaceutical has an independently constructed protein-protein interaction targeted drug design platform, which is at the forefront
of the global research and development of new drugs for the apoptosis pathway.
The company has established 9 Class 1 small molecule new drug pipelines that have entered the clinical development stage, including inhibitors that inhibit key proteins such as Bcl-2, IAP or MDM2-p53 in the apoptosis pathway; The new generation of inhibitors for kinase mutants that occur in cancer treatment is the only innovative company
in the world that has clinically developed varieties in the field of key proteins in the apoptosis pathway.
The company is currently conducting more than 50 Phase I/II clinical trials
in China, the United States, Australia and Europe.
The core variety of orebatinib (trade name: Nerik ®) used for the treatment of drug-resistant chronic myeloid leukemia has been included in the priority review and breakthrough treatment varieties by the New Drug Evaluation Center (CDE) of the State Drug Administration of China, and has been approved in China, which is the company's first listed variety
.
The variety has also obtained the US FDA Fast Track Qualification, Orphan Drug Qualification, and EU Orphan Drug Qualification
.
Up to now, the company has obtained 15 FDA and 1 EU orphan drug qualification certification, 2 FDA fast-track qualifications and 2 FDA pediatric rare disease qualification certifications
in the company.
The company has undertaken a number of major national science and technology projects, including 5 "major new drug creation" projects, including 1 "enterprise innovative drug incubation base" and 4 "innovative drug research and development", and 1 special project of "prevention and treatment of major infectious diseases"
.

With strong R&D capabilities, AXA Pharmaceutical has carried out intellectual property layout around the world and reached global cooperative relations
with leading biotechnology and pharmaceutical companies and academic institutions such as UNITY, MD Anderson, Mayo Medical Center and Dana-Farber Cancer Institute, Merck, AstraZeneca, Pfizer and so on.
The company has established an international talent team with rich experience in the research and development and clinical development of original innovative drugs, and at the same time, the company is building a commercial production and marketing team
in the later stage with high standards.
Yasheng Pharmaceutical will continue to improve its R&D capabilities, accelerate the clinical development progress of the company's product pipeline, and truly implement the mission of "solving the unmet clinical needs of patients in China and even around the world" to benefit more patients
.

Forward-looking statements

The forward-looking statements made herein relate only to events or information made on the date in which such statement is made
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unforeseen events after the date of the forward-looking statements, whether or not new information, future events or other circumstances
arise.
Please read this article carefully and understand that our actual future results or performance may differ materially from
expectations.
All statements contained herein are made at the date of publication of this article and are subject to change due to future developments
.

Source: Yasheng Pharmaceutical