The rare disease track of the two sessions will usher in another leading listed pharmaceutical company

At the two sessions just concluded this year, "strengthening the protection of drugs for rare diseases" was officially written into the government work report.
At the policy level, rare diseases will usher in strong support
.

Although the incidence of rare diseases is extremely low, there are still a large group of rare diseases in China with a large population base

Therefore, rare diseases are both medical and social problems
.

Recently, another biopharmaceutical company focusing on orphan drugs and rare diseases is sprinting to the Hong Kong Stock Exchange, and may take advantage of this situation
.

Focus on organ fibrosis treatment

Focus on organ fibrosis treatment

According to public information, Beijing Kangdini Pharmaceutical Co.
, Ltd.
("Kantini Pharmaceutical") is a biopharmaceutical enterprise specializing in the research, development and commercialization of innovative drugs for organ fibrosis for 20 years
.

Compared with many Biotechs currently listed in Hong Kong stocks, Condini Pharmaceuticals has already launched products on the market and has generated considerable sales revenue
.

As the flagship product of Condini Pharmaceuticals, it was approved in China in 2011.
It is one of the first three drugs in the world to be approved for the treatment of IPF (idiopathic pulmonary fibrosis), and it is also the first drug in China.
The drug approved for the treatment of IPF fills the gap in the treatment of IPF in China, and has been included in the National Medical Insurance List since 2017
.

According to statistics, the market size of China's IPF treatment in 2020 is 478 million yuan, and the total disclosed revenue of Essary is 437 million yuan, accounting for 91.
4% of the market share.
's leader
.

In addition, Esprit is expanding its indications to other pulmonary fibrotic diseases, including systemic sclerosis-associated interstitial lung disease (SSc-ILD), dermatomyositis-associated interstitial lung disease (DM-ILD), pneumoconiosis and The disease of renal fibrosis
.

In addition to Esery, Condini Pharmaceuticals has also built a pipeline of products under development for liver fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, and acute and acute-on-chronic liver failure
.

Source of Condini Pharmaceutical's R&D pipeline: prospectus

F351

F351

Potential blockbuster drug to reverse chronic hepatitis B-related liver fibrosis

By inhibiting the proliferation of hepatic stellate cells and the TGF-β signaling pathway, F351 can effectively treat hepatic fibrosis in chronic hepatitis B and reverse hepatic fibrosis
.

F351 has been included in the breakthrough therapy category by the Center for Drug Evaluation in March 2021, and patients will be enrolled in the Phase III clinical trial in January 2022.

F573

F573

A potential new class of drugs for the treatment of acute and acute-on-chronic liver failure

F573 is a caspase inhibitor and is expected to become a new class of drugs for the treatment of acute and acute-on-chronic liver failure
.

There is currently no effective treatment for acute and acute-on-chronic liver failure

F528

F528

Potential first-line therapy for chronic obstructive pulmonary disease

F528 is an anti-inflammatory small-molecule drug for the treatment of chronic obstructive pulmonary disease.
It targets a variety of inflammatory cytokines and can alter the progression of chronic obstructive pulmonary disease with minimal toxicity in vivo
.

Currently, F528 is in the preclinical research stage, and it is planned to submit a clinical trial application in the fourth quarter of 2022

F230

F230

EPA-selective antagonists for the treatment of pulmonary arterial hypertension

F230 is a selective receptor antagonist for the treatment of pulmonary arterial hypertension.
It is currently in the preclinical research stage and plans to submit a clinical trial application in 2023
.

It can be seen from the above pipeline that Condini Pharmaceuticals has chosen a subdivision field that few people participate in.
At the moment when innovative drugs are facing the "involution" of some varieties, such a differentiated competitive strategy is a wise choice
.

Moreover, in terms of market size, such segments are not necessarily smaller than some large varieties
.

A promising market

A promising market

Organ fibrosis, including pulmonary fibrosis, liver fibrosis, renal fibrosis and cardiac fibrosis, is one of the leading causes of disease and death worldwide
.

In 2020, the number of patients with major organ fibrosis in China will reach 159 million

Among them, pulmonary fibrosis mainly includes IPF, non-idiopathic interstitial pneumonia, pneumoconiosis and other diseases
.

According to relevant statistics, the number of patients with IPF in China has increased from 83,000 in 2017 to 108,000 in 2020, with a compound annual growth rate of 9.
3%, and is expected to increase to 332,000 by 2031; non-idiopathic interstitial The number of pneumonia patients increased from 2.
3 million in 2017 to 240,000 in 2020, and is expected to reach 2.
6 million in 2031; the number of pneumoconiosis patients in China increased from 850,000 in 2017 to 905,000 in 2020.
It is expected to increase to 1.
015 million by 2031
.

At the same time, the market size of anti-fibrotic drugs for IPF, non-idiopathic interstitial pneumonia and pneumoconiosis in China increased from 98.
2 million yuan in 2017 to 499 million yuan in 2020, with a CAGR of 71.
9% , is expected to increase to 6.
73 billion yuan by 2031
.

At present, there are two commercialized IPF drugs on the market in China: pirfenidone and nintedanib
.

Both drugs have been clinically shown to delay the formation of scar tissue in the lungs of IPF patients, and are the only two effective drugs in China and the world

Source of domestic IPF drug research and development: prospectus

In addition, Condini Pharma's Asiri is the only anti-fibrotic drug candidate to enter clinical trials for SSc-ILD or DM-ILD indications
.

In addition, the pirfenidone drugs of Essray and Conba have entered the clinical stage for pneumoconiosis and are expected to become the first anti-fibrotic drugs for the treatment of pneumoconiosis

Liver fibrosis is the pathological change of most chronic liver diseases such as chronic hepatitis B (CHB), chronic hepatitis C (CHC), alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD)
.

The number of liver fibrosis patients in China increased from 136 million in 2017 to 138 million in 2020
.

In 2020, the number of patients with CHB-related liver fibrosis in China accounted for 46.

While the number of patients has increased, the current market size of anti-hepatic fibrosis drugs in China has increased from 928 million yuan in 2017 to 1.
067 billion yuan in 2020
.
So far, no specific anti-fibrosis drug has been approved in the world.
F351 of Condini Pharmaceuticals is the fastest-advancing anti-fibrosis drug candidate in this field in China and around the world
.

With the approval of the first F351 for the treatment of CHB-related liver fibrosis, it may lead to faster development of the market in China
.
Therefore, the market is expected to expand to 5.
429 billion yuan by 2031
.

Source of domestic research and development of anti-hepatic fibrosis drugs: prospectus

Renal fibrosis is the most common tissue and pathological change associated with chronic kidney diseases such as diabetes, hypertension and bacterial infection, and is an important pathological feature of kidney damage
.
At present, there are no anti-fibrotic drugs approved for the treatment of any kidney disease at home and abroad
.

It can be seen from the market structure that the anti-organ fibrosis drugs currently being developed by Condini have a market of over 1.
5 billion yuan, and the future space is broad
.
Over the years, Condini Pharmaceuticals has also made a lot of efforts on the road to capitalization, but the road to listing is still full of twists and turns
.

Two failures, three red Hong Kong stocks dream come true?

Two failures, three red Hong Kong stocks dream come true?

From the perspective of controlling shareholders, Condini Pharmaceuticals is a Japanese-funded enterprise
.

In 2002, Condini Pharmaceutical was established, and Condini Pharmaceutical Factory held 80% of the shares and Cheng Youming held 20% of the shares; in 2006, Japanese company GNI acquired 12% of Condini Pharmaceuticals at a price of 122 million yen (approximately 122 million yen).
8.
4 million yuan); in 2011, GNI and Shanghai Ruixing Gene subscribed for 10 million yuan and 3.
53 million yuan respectively, GNI's shareholding increased to 39.
44%, and Shanghai Ruixing Gene accounted for 11.
56%
.

Since 2013, Condini Pharma has completed several rounds of investment
.
Among them, in 2013, Longpan Ventures invested 13.
089 million yuan; in 2015, Longpan Biomedical invested 22 million yuan; in 2020, Aaring and Nepenthe invested 20 million yuan and 16 million yuan respectively; in 2022, Bilinnier invested 19.
059 million yuan
.

After complicated equity transfer and reorganization, as of the time of submission of the prospectus, GNI held 55.
97% of the shares of Contini Pharmaceutical through BJContinent, and was the controlling shareholder; Longpan Biopharmaceutical and Longpan Venture Capital held a total of 17.
48%; Shengli Li holds 11.
66% and so on
.

However, among the shareholders of Condini Pharmaceuticals, we could not find many well-known and well-known venture capital institutions, and most of the shareholders are from related parties of the management of Condini Pharmaceuticals
.

For example, St.
Lili is owned by Jiang Xiaoxing (son of the late founder); Longpan Biopharmaceutical and Longpan Ventures are owned by Yu Zhihua, the spouse of deputy director of investment project marketing; Ratel Consulting is owned by Ma Songjiang, executive director; Ratel is owned by Mr.
Ma Songjiang's spouse Zhu Yueying owns and so on
.

This kind of shareholder composition is very special compared with many Hong Kong stocks Biotech
.

In terms of finance, since Condini Pharmaceutical has been established for 20 years and has mature products sold in the market, the operating profit is quite considerable
.
In 2019, 2020 and the first three quarters of 2021, the total revenue was 325 million yuan, 447 million yuan and 440 million yuan respectively; the net profit was 70.
1 million yuan, 128 million yuan and 126 million yuan respectively
.

However, the proportion of research and development investment of Kangtini Pharmaceutical is very low.
In 2019, 2020 and the first three quarters of 2021, its research and development expenses were 15.
85 million yuan, 37.
212 million yuan and 33.
17 million yuan respectively, accounting for only 10% of total revenue.
There are 4.
9%, 8.
3% and 7.
5%
.

Under the dual effects of capital and revenue, Condini Pharmaceuticals has attacked the Hong Kong Stock Exchange three times, but the first two have failed
.
It remains to be seen whether Condini Pharmaceutical can realize its dream this time
.

Epilogue

Epilogue

In the past, many pharmaceutical companies could gain a firm foothold in the market by relying on a big-selling "explosive product", such as Betta Pharmaceuticals, etc.
However, with the advent of the era of centralized procurement, at the moment when everything is available for centralized procurement, single The situation of dominance of products must be changed, otherwise it will face the danger of being abandoned by the times
.
Condini Pharmaceuticals focuses on orphan drugs and rare disease drugs, and has received clear policy support.
If it can successfully land in the capital market, it may break out into a vast world
.
Shell Society will continue to pay attention to the follow-up development
.

References

References

1.
Prospectus of Condini Pharmaceuticals