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Text | Rainbow
Recently, the clinical trial (IND) application of Selinexor (Chinese name: Celiniso) for the treatment of advanced or recurrent endometrial cancer phase III clinical trials in China was approved by the State Food and Drug Administration.
Selinexor is a selective nuclear export inhibitor (SINE) targeting the key nuclear export protein XPO1, originally designed and developed by the American biopharmaceutical company Karyopharm Therapeutics.
It is understood that Selinexor is the first drug to enter the market in Deqi's pharmaceutical product pipeline, and it is also the company's core asset.
Selinexor research and development progress
Image source: Deqi Pharmaceutical's official website
It is worth noting that Selinexor's indications are mainly laid out in multiple myeloma.
Multiple myeloma racetracks are divided, BMS dominates
Multiple myeloma racetracks are divided, BMS dominatesMultiple myeloma is a middle-aged and elderly disease.
In the context of such a huge market scale, there are too many new drug development projects for multiple myeloma.
In March 2020, the US FDA approved the use of Sarclisa injection combined with pomalidomide and dexamethasone for adult patients with multiple myeloma.
In May 2020, the US FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, a new subcutaneous injection of Darzalex) for newly diagnosed multiple myeloma patients, multiple myeloma patients who are not eligible for transplantation, and recurrence Or patients with refractory multiple myeloma.
In August 2020, the US FDA approved Blenrep for adult patients with relapsed or refractory multiple myeloma who have received at least 4 treatments, including anti-cd38 monoclonal antibodies, proteasome inhibitors and immunomodulators.
In August 2020, the US FDA approved carfilzomib and daratumumab in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received first to third line treatment.
It is reported that the treatment of multiple myeloma at home and abroad is mainly focused on three major "damine" drugs, namely thalidomide, lenalidomide and pomalidomide, and "zomi" drugs such as bortezomib and carbohydrate.
In addition, in addition to the multiple myeloma drugs that have been approved for the above types, there are other new researches joining the competition, such as bispecific antibodies.
Statistics show that the approved treatments for multiple myeloma around the world are mainly concentrated in the hands of multinational pharmaceutical companies such as BMS and Johnson & Johnson.
It is worth mentioning that both lenalidomide and pomalidomide are owned by Bristol-Myers Squibb (BMS).
The financial report data of Karyopharm Therapeutics shows that in 2020, selinexor's annual sales are 108.
Then, under the fierce competition of this group of heroes, how much surplus market the latecomers can share, and even say that they want to go further and compete with the "predecessors", so as to "get food from the tiger's mouth".
Deqi Pharmaceutical's poor performance after listing in Hong Kong stocks, Selinexor has a long way to go
Deqi Pharmaceutical's poor performance after listing in Hong Kong stocks, Selinexor has a long way to goDeck Pharma is a biopharmaceutical company with innovative anti-tumor drugs.
The company was established in 2016 and was listed on the Hong Kong Stock Exchange on November 20 last year.
Lisence-in is the current business model of Deqi Pharmaceuticals.
The company's R&D pipeline includes 12 drugs, including 7 Lisence-In products.
The research and development progress is relatively fast, and the remaining self-developed products are not yet mature.
Image source: Deqi Pharmaceutical's official WeChat
In fact, Deqi Pharmaceuticals is often used in the industry to benchmark against Zai Lab, which also engages in Lisence-in.
Since 2017, Zai Lab was listed on the Nasdaq in the United States by virtue of its License-in+CRO+VC business model.
The stock price has been rising all the way, and the License-in model has also begun to be sought after by a number of domestic pharmaceutical companies.
In this context, the industry is also optimistic about Deqi Pharmaceuticals, and the financing path is also much smoother.
Since its establishment in 2016, Deqi Pharmaceuticals has successively received investment from institutions including Fidelity, BlackRock, GIC, Hillhouse, Boyu Capital, Fangyuan Capital and Qiming Venture Capital; in addition, Celgene, WuXi AppTec and Tigermed Pharmaceuticals, etc.
Industry investors bet on it.
Overview of the progress of Deqi Pharmaceuticals IPO:
In October 2017, the Series A financing raised a total of US$21 million, with a valuation of US$109 million.
In February 2019, the Series B financing raised a total of US$120 million, with a valuation of US$370 million.
In July 2020, Series C financing received US$97 million led by Fidelity Entity, with a valuation of US$726 million.
On November 20, 2020, the Hong Kong Stock Exchange was listed, with a market value of approximately HK$12 billion on that day.
From a valuation of US$109 million in 2017 to a market value of HK$12 billion (US$1.
544 billion) on the market, Deqi Pharmaceutical’s valuation has doubled by 14 times in three years.
However, the good times did not last long.
Compared with the previous stage, the financing process was as smooth as the “opening up” of the financing process.
The overall performance of Deqi Pharmaceuticals after its listing in Hong Kong stocks is staggering.
On the day of listing on the Hong Kong Stock Exchange, the opening price of Deqi Pharmaceuticals Hong Kong stocks was HK$19.
6 per share, an increase of 8.
41% from the issue price (HK$18.
08).
As of the day's close, it was reported at HK$18.
28 per share, an increase of 1.
11%.
However, the next day, the share price of Deqi Pharmaceuticals opened lower and fell below the issue price.
As of the close of this Friday (May 14), Deqi Pharmaceuticals closed at HK$15.
66 per share, down 13.
38% from the issue price, and the total market value was HK$10.
5 billion.
Compared with Zai Lab, which was listed on the Hong Kong Stock Exchange two months earlier (September 28), the stock price since its listing (returned at HK$1,172 as of this Friday, up 108.
54% from the issue price) has shown a slight overall upward trend.
Weak.
In addition, it is worth mentioning that Deqi Pharmaceuticals has not yet generated any revenue from product sales.
According to the 2020 annual performance report released by Deqi Pharmaceuticals this year, as of December 31, 2020, Deqi Pharmaceuticals had cash and bank balances of RMB 3.
11 billion, a year-on-year increase of 317%.
After adjustment, the loss for the year was 455 million yuan.
Under such a situation, the commercialization of Selinexor, its core asset, has become extremely critical for Deqi Pharmaceuticals.
Fortunately, in January this year, Selinexor's new drug application (NDA) for the treatment of patients with refractory and relapsed multiple myeloma has been accepted by the State Food and Drug Administration.
In addition, benefiting from the Hainan Free Trade Port policy, the drug was first prescribed in the mainland in Hainan not long ago and was allowed to be taken away for use.
From this point of view, Selinexor's regulatory path is still smooth.
However, the performance of product commercialization, apart from the fierce market competition mentioned above, also depends to a large extent on the policy environment and team level.
In terms of policy, it is inevitable to say that under the current domestic policy background, after the launch of innovative drugs, they generally face the pressure of medical insurance negotiations and mass purchases.
In other words, in terms of product prices, the business side can no longer occupy more advantages.
In this way, sales volume is the key to the successful commercialization of the product, and the level of the sales team has therefore become crucial.
Prior to this, Deqi Pharmaceutical disclosed that it has 90 employees, but half of them are R&D and development personnel, and the commercial team has not yet formed.
However, there was news recently that Deqi Pharmaceuticals expects to build a commercial team of about 150 people by the end of this year.
In general, Deqi Pharmaceuticals under the license-in model has a long way to go before it wants to turn losses into profits and gain favor in the capital market.
Reference material: Yaozhi.
com "200+ Billion USD MM Market! 14 models are on the market globally and 25 models are under research in China; BMS, Johnson & Johnson, Haite Bio.
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