CStone Pharmaceuticals releases semi-annual financial report: two new drugs will be approved soon for commercialization into the fast lane

With the approval of the two products in the first half of the year, Hong Kong stock innovative pharmaceutical company Cornerstone Pharmaceuticals (HKEX: 2616) has not only proven its R&D capabilities to the market, but also demonstrated its efficient commercialization capabilities to the outside world
.

On August 26, CStone Pharmaceuticals announced the 2021 semi-annual report, the first report card after commercialization, with revenue of 79.

Dr.
Jiang Ningjun, Chairman and CEO of CStone Pharmaceuticals, stated that in the first half of 2021, as an all-round biopharmaceutical company, CStone Pharmaceuticals has made further milestones in commercialization, clinical development, pipeline 2.
0, and Major breakthroughs have been made in business development and capital markets
.

"In the first half of the year, the company successfully listed two first-of-its-kind precision treatment drugs for oncology, Pujihua® and Taijihua®, and achieved considerable sales performance

Commercialization enters the fast track national market to accelerate coverage

The first half of 2021 is the most active period of commercialization in the history of CStone Pharmaceuticals.
The company has achieved the market launch of two precision treatment drugs at a speed that has attracted attention in the industry
.

On March 24, Pujihua® (Platinib Capsules) was approved, which was the first approved selective RET inhibitor in China; a week later, Taijihua® (Avatinib Tablets) was a new drug The marketing application has also been approved, and it is China's first drug approved for the treatment of gastrointestinal stromal tumors with PDGFRA exon 18 mutations

In order to promote the successful launch of products, CStone Pharmaceuticals has expanded the coverage of the drug market by cooperating with medical service providers, regulatory agencies, hospitals, pharmacies, insurance companies, and other groups in the medical industry.
It currently covers more than 400 in more than 130 cities.
A hospital
.

The nationwide market coverage is accelerating, and the covered hospitals account for approximately 70-80% of the precision medicine-related market

Through a strategic cooperation agreement signed with Sinopharm Holdings Co.
, Ltd.
(Sinopharm Holdings), CStone Pharmaceuticals has expanded the distribution scope of Phuket Hua ® and Tai Ji Hua ® in hospitals and pharmacies in mainland China
.

By cooperating with the Lingang New Area (Lingang) of the China (Shanghai) Pilot Free Trade Zone, CStone Pharmaceuticals completed the customs clearance and port inspection procedures within four days, which was much earlier than expected and far surpassed the industry average speed

So far, CStone Pharmaceuticals has built a strong commercial network, which not only escorts the two products already on the market, but also pave the way for future product launches
.

As of the reporting period, the sales performance of Taijihua ® and Phuket Hua ® reached RMB 33,600,000 and RMB 45.

Major breakthroughs in research and development, continuous linking of global resources, showing pioneering effects

In addition to commercialization, in the first half of this year, many late-stage drug candidates that are in key clinical trials or registration stages frequently reported good news, and many major breakthroughs were made in clinical research and development
.

In addition to the already approved Pujihua® submitted NDA for the treatment of patients with advanced or metastatic RET mutant MTC and RET fusion-positive thyroid cancer, two other products are expected to be launched in the second half of this year

Earlier this year, CStone Pharmaceuticals announced the PD-L1 new drug sugarizumab as a consolidation treatment for locally advanced/unresectable (stage III) non-small cell lung cancer that has not progressed after concurrent or sequential radiotherapy and chemotherapy.
NSCLC) clinical study results of patients
.

In August of this year, CStone Pharmaceuticals submitted an NDA for this indication to the National Medical Products Administration (NMPA) of China.

The clinical research of IDH1 inhibitor Afnib also made a major breakthrough in the first half of the year
.
Avnib is the first IDH1 inhibitor in China that has shown efficacy and sustained remission for patients with R/R AML
.
At present, NMPA has accepted the NDA of Afnib for the treatment of R/R AML adult patients susceptible to IDH1 mutations, and has granted priority review qualifications
.
The NDA is expected to be approved at the end of this year or the first quarter of next year
.
According to a news released this month by CStone’s partner Servier, a global phase III study of the combination of Afnib and azacitidine in the treatment of patients with previously untreated IDH1 mutant acute myeloid leukemia, due to its excellent efficacy Data, further entry into the group has been stopped early
.
CStone Pharmaceuticals plans to submit the NDA for this indication to NMPA in 2022
.

According to the latest news on August 26, Afnib has also been approved by the US FDA for the treatment of IDH1 mutant cholangiocarcinoma, becoming the world's first targeted therapy drug approved by the US FDA for this indication
.

At the same time, CStone Pharmaceuticals is promoting the development prospects of later pipeline products and consolidating pipeline development through strategic relationships
.
CStone Pharmaceuticals is currently cooperating with Pfizer to plan to commercialize sugarizumab for the treatment of stage IV NSCLC in mainland China
.
Based on the strategic cooperation reached last year, in June of this year, CStone Pharmaceuticals announced that it would cooperate with Pfizer to jointly develop Pfizer's late-stage oncology product loratinib in Greater China
.
In the future, loratinib will form a "combination punch" with Pugeta® and Shuglizumab together as the cornerstone pharmaceutical industry to occupy an absolute leading position in the field of lung cancer treatment
.

In overseas markets, CStone Pharmaceuticals collaborated with EQRx to negotiate with stakeholders in major global markets such as the United States, the United Kingdom and the European Union on the registration of sugarizumab for the treatment of NSCLC indications
.
It is reported that CStone Pharmaceuticals is cooperating with EQRx to explore the feasibility of expanding the scope of the drug's indications, such as gastric cancer, esophageal cancer, etc.
, and is cooperating in the United States and major European markets to expand CS1003's phase III study of hepatocellular carcinoma
.

In terms of pipeline 2.
0, CStone Pharmaceuticals will strengthen endogenous innovation capabilities through unremitting efforts in research and development, and create a differentiated innovative drug pipeline with global rights
.
In the first half of this year, CStone Pharmaceuticals further promoted antibody-conjugated drugs (ADC) and multi-specific antibodies.
These two key products have made significant progress in entering the clinical research phase
.
Among them, the CS2006 trispecific antibody clinical research is being carried out in the United States and Taiwan, China, and the clinical trial application (IND) was also accepted by the NMPA in July this year
.
CS5001 (LCB71, ROR1 ADC) is being used for global IND preparation studies, and it is expected that the IND/CTA will be submitted in the United States/Australia before the end of 2021
.

In this regard, Jiang Ningjun revealed that CStone Pharmaceuticals will comprehensively accelerate its clinical development plan in the future, consolidate its advantages in the field of lung cancer and continue to strengthen research and development for other high-incidence cancers.
It is expected to submit more than five NDA applications in 2022
.
"For pipeline 2.
0 products that have the first-in-class/best-in-class/first-echelon potential and global rights and interests, one or two IND applications will also be submitted to further enhance drug research and give full play to the potential of pipeline 2.
0
.
"

Outstanding Capital Market Performance Valuation Steps into a New Turning Point

Strong R&D capabilities and rapid commercialization capabilities have made CStone's performance in the capital market also remarkable this year
.
Just a few days ago, CStone Pharmaceuticals was included by the Hang Seng Index Company as constituent stocks of the Hang Seng Composite Index, which will take effect on September 6.
This will inevitably further promote CStone's attention in the capital market, expand investor groups, and benefit Promote the company's long-term sustainable development
.

Not only that, recently, EQRx was actively subscribed by a number of major investment institutions including SoftBank at a pre-investment valuation of US$4.
15 billion.
Among them, the overseas interests of Shuglizumab accounted for 3/4 of its overall valuation.
The news also boosted market expectations for the valuation of CStone Pharmaceuticals
.

The recent positive actions of international investment banks have further confirmed the company's current low valuation and long-term value
.
Just in the middle of this month, top investment banks Morgan Stanley and Goldman Sachs respectively released research reports, giving CStone an overweight rating, and at the same time substantially raised the company's target stock price
.
Among them, Morgan Stanley raised from HK$14.
0/share to HK$21.
5/share, an increase of 54%
.
Goldman Sachs raised from HK$14.
8/share to HK$18.
0/share, an increase of 22%
.

According to reports from investment banks, compared with listed companies in Hong Kong stocks with similar pipeline progress and R&D capabilities, CStone's current valuation is severely underestimated and its attractiveness is higher
.
The successful inclusion of CStone Pharmaceuticals in the Hang Seng Index and its expectation of entering Southbound Trading at the beginning of next month have also become another proof that CStone Pharmaceuticals' value has been recognized by the capital market again
.
With the catalysis of this series of good news and the opening of the valve for the influx of market funds, the valuation of CStone Pharmaceuticals is also expected to move towards a new turning point
.