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Hong Kong stocks have finally welcomed another biomedical company
.
Today, 3D Pharmaceuticals Inc.
, a biotechnology company focusing on the R&D and commercialization of innovative drugs for tumor immunotherapy, successfully listed on the Hong Kong Stock Exchange
.
Its parent company, IdeaDia, is an oncology precision medicine company with Mindi Pharmaceuticals and Siddy Diagnostics, which were spun off
in 2018.
Sidi Pharma obtained multiple rounds of financing before the IPO, including many well-known investment institutions
such as Hillhouse Capital, Yifeng Capital, and CSC Investment Hyde Capital.
Envida has 1 core single product, PD-L1 monoclonal antibody Enveda, and 11 drug candidates, most of which are licensed by other companies, covering immuno-oncology monotherapy, innovative drug candidates with mechanisms of action that can be combined with pipeline products, and pain management assets, but the company has not yet achieved profitability
.
Since 2018, the listing of Hong Kong stocks has become an important step
for unprofitable biopharmaceutical companies to "replenish blood".
The plunge in Hong Kong stocks since last year has hit the share prices of these companies hard, with pricing distortions and illiquidity, and biotech companies' market capitalization has been suffering
.
At the same time, it can be noted that at the beginning of December, in addition to Sidi Pharmaceutical, all biopharmaceutical companies with new IPO developments in the Hong Kong Stock Exchange include: Youzhiyou Biotechnology, a bispecific antibody drug R&D and production company, has submitted an IPO application to the Hong Kong Stock Exchange, and Boan Biotechnology, a subsidiary of Luye Pharmaceutical, has passed the listing hearing of the Hong Kong Stock Exchange, and so on
.
Sidi Pharma is the fifth biopharmaceutical company listed in Hong Kong in 2022, and the top four Hong Kong IPOs this year are Lepu Biologics, Rico Biologics, Biocytogen and Emmi Vaccines
.
The CEO of Sidi Pharma is Dr.
Gong Zhaolong, a former FDA new drug review expert, and its partners include Corning Jerry, Simcere Pharmaceutical, SELLAS, Aravive, etc.
, which can be completed within four years after the spin-off, which is also a confirmation
of its clinical development capabilities, resource deployment integration and commercialization advantages.
Gong Zhaolong, a former FDA new drug review expert, and its partners include Corning Jerry, Simcere Pharmaceutical, SELLAS, Aravive, etc.
, which can be completed within four years after the spin-off, which is also a confirmation
of its clinical development capabilities, resource deployment integration and commercialization advantages.
Sangu Hong Kong Stock Exchange was finally successful
Sangu Hong Kong Stock Exchange was finally successfulThis is the third time that Sidi Pharma has submitted a Hong Kong stock prospectus
.
Prior to this, the Company had submitted prospectuses to HKEX on 30 June 2021 and 31 December 2021 respectively, but both prospectuses lapsed
due to failure to pass the HKEX hearing within 6 months.
Although the sprint to the secondary market has experienced twists and turns, in the primary market, Siddy Pharmaceutical has always been the target favored by investment institutions
.
Prior to submitting the IPO application, the company had completed several rounds of financing, with investment institutions covering Hillhouse Capital, New Horizon Capital, Leanfront Capital, CSC Investment, Simcere Pharmaceutical, Tigermed Pharmaceutical, etc.
, with a cumulative financing amount of US$230 million, or about RMB1.
55
billion.
According to the prospectus, the post-investment valuation of Siddi Pharmaceutical has reached 700 million US dollars
.
Under intensive financing, Di Pharma is still obsessed with the idea of IPO listing, apparently because of the greater demand
for cash flow maintenance.
The growth path of innovative pharmaceutical companies has generally experienced the path
of "burning money" research and development in the early stage, and then "returning to blood" when the product is launched.
According to the prospectus, the R&D investment of Sidi Pharma in 2019 and 2020 was 230 million yuan and 264 million yuan
respectively.
In addition, in February 2021, the R&D and production base of Sidi Pharmaceutical officially started construction in Xuzhou, this self-built GMP workshop covers an area of about 80,000 square meters, with a total investment of 2.
5 billion yuan.
In the first five months of 2020, 2021 and 2022, the operating income of Siddi was 0, 60 million and 161 million yuan, respectively; The corresponding net losses were RMB635
million, RMB1,462 million and RMB293 million, respectively.
At the end of May this year, the Group had $660 million in cash and cash equivalents
.
However, like most biotech companies listed in Hong Kong IPOs this year, the amount raised by Siddi Pharma is not large, according to the offering, the company raised up to HK$
429 million.
According to the prospectus, the funds raised by the IPO were mainly used for the research and development, regulatory filing and commercialization of products and drug candidates; For business development activities, expansion of drug pipeline and portfolio, potential acquisition of high-value and unique innovative assets, etc
.
Almost all of the pipeline drugs of Mindi Pharma are licensed from other companies, and its self-developed drugs are still in the early clinical or preclinical stage
.
The idea that it will take time to make a profit may be related to the official approval and commercialization progress of its core product, Envolimab, that is
, Envida.
Approved in November 2021 and commercialized in December 2021, this PD-L1 monoclonal antibody is suitable for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite hyperinstability (MSI-H) or mismatch repair gene defective type (dMMR) administered subcutaneously, while most competitors are administered
intravenously.
In April 2022, Envida wrote three 2022 CSCO guides
.
According to official data, as of May 31, 2022, the sales revenue of this variety since commercialization was 221 million yuan
.
The CEO is a former FDA new drug review expert, and "BLA filing" is a strong point
The CEO is a former FDA new drug review expert, and "BLA filing" is a strong pointIt is worth noting that Envida is not unique to Mindi
Pharmaceutical.
Envida was originally a product independently developed by Corning Jereh Pharmaceutical, internally codenamed KN035, and Sidi Pharma began to participate in joint research and development in 2016, and then the promotion right of this PD-L1 in mainland China was handed over to Simcere Pharmaceutical, which is also one of
the shareholders of Simcere Pharmaceutical.
According to the sales plan, after a certain percentage of the addition, Corning Jereh will sell the drug to Simcere Pharmaceutical at the factory price, and the latter will withdraw a certain sales share from the revenue after completing the commercial sales, and the remaining pre-tax profit will be divided
equally between Sidi and Corning Jerry.
Although the sharing of a PD-L1 by the three innovative drug companies will reduce the benefits obtained by Sidi Pharmaceutical, it can be seen from this cooperation that Sidi Pharma's resource deployment integration advantages and commercialization capabilities
.
According to the Chinese Antibody Association, the IND application of Envida, which was still KN035 at that time, was the first project in China to directly declare to the FDA without clinical data and was approved to carry out the world's first clinical trial in the United States
.
Under the collaborative development agreement between Corning Jerry and ThinkTech, Corning Jerry is responsible for clinical sample and post-market drug manufacturing, and SmartJet leads global registration, clinical development and commercialization
.
The cooperation between ThinkDie Pharmaceuticals and Corning Jerry can be described as efficient, and only 9 months after the signing of the cooperation agreement, the two companies successfully declared the project for the world's first clinical trial in the United States without clinical data, and completed the submission of IND to BLA approval within 4 years, completing the overall process
of new drug development.
of new drug development.
Envida is the world's first subcutaneous PD-L1 antibody
approved for BLA.
According to FDA requirements, a drug needs to go through preclinical trials, new drug clinical trial applications, clinical trials and other steps from development to marketing, and finally submit a BLA (Biologics License Application) or NDA
.
Frost & Sullivan research shows that it typically takes five to six years
for innovative oncology drugs to advance from the IND stage to the BLA or NDA stage.
According to the prospectus of Sidi Pharmaceutical, "BLA filing" is the strength of Sidi Pharmaceutical, and the company can efficiently recruit patients
in clinical trials in many countries and regions by virtue of the trial management and technical advantages of the clinical team.
At the same time, the advantages of the international registration of Siddi Pharma are inseparable from its CEO, Dr.
Gong Zhaolong, who has 10 years of experience in FDA new drug review and is also one of the first batch of former FDA review experts
to return to China to start a business.
After returning to China, he served as a senior executive in BeiGene and other new drug R&D companies, participated in and promoted the rapid entry of three BeiGene innovative drugs into clinical development and foreign rights transfer, and was familiar with the relevant international regulations
of drug development and review.
At present, the commercialization cooperation layout of ThinkPharma is broad, and other domestic and multinational well-known pharmaceutical and biotechnology companies that have established cooperative relationships include Merck, TRACON, SELLAS, Aravive, Haihe Pharmaceutical, Y-Biologics and Immune
Oncia and others
.
Specific collaborations include clinical trials with TRACON in the United States, Canada and Mexico for patients with soft tissue sarcoma, and co-dosing
studies of Envida and Merck's monoclonal antibody cetuximab targeting the epidermal growth factor receptor (EGFR).
The ecological layout of chronic tumor disease can be preliminarily seen
The ecological layout of chronic tumor disease can be preliminarily seenFocusing on the company's cooperative commercialization products, Ideadi Pharma tries to build an ecological matrix
for chronic tumor disease.
In particular, the prospectus of Ideadi Pharma states that chronic cancer treatment has become a major trend in the future of cancer treatment, and the company has focused on forming and developing a portfolio of therapies to help cancer patients
who need long-term treatment.
for chronic tumor disease.
According to the official website information, according to the positioning of "major market players in the cancer treatment chronic disease market", the company's layout method is: tumor immune pipeline as the core, deployment of single-drug/combination tumor product matrix, including multi-indication antibody new drugs and tumor vaccines; Pain management solutions are auxiliary, including tumor pain, postoperative toothache, etc.
; In the future, in addition to continuing to target multi-indication tumor immunotherapy, the future product will also lay out metastatic solid tumors and locally advanced solid tumor pipelines as synergies
.
▲Idea Di Pharmaceutical pipeline layout, source: company official website
And from the current core products, prognosis, delayed recurrence, and optimized drug delivery are the keywords
for Sidi Pharma to participate in the growth of China's oncology drug market.
Such as Galinpepimut-S, the peptide cancer vaccine in research in collaboration with SELLAS
(3D189), which was approved by the NMPA in April this year, is used in a Phase I clinical study
to evaluate the safety and immunogenicity of this drug in patients with hematological cancers.
3D189 is a new generation of potential "first-in-class" tumor immunotherapy drugs targeting WT1 (Wilms tumor protein), which has the potential to target therapy in more than 20 cancers (including lung cancer and colorectal cancer) that overexpress WT1, and is designed to prevent and delay recurrence (by prolonging progression-free survival) and is expected to prolong the survival of
these patients.
There is also 3D229 (also known as AVB-500), an inhibitor targeting the GAS6-AXL signaling pathway in collaboration with Aravive, a new anti-ovarian cancer drug approved by CDE in July last year to join the international multi-center phase III clinical trial
.
Ovarian cancer has a poor prognosis, a 5-year survival rate of only 40%, and is prone to recurrence, and about 70-80% of patients who are sensitive to platinum therapy are eventually resistant to platinum chemotherapy after multiple relapses
.
GAS6-AXL signaling pathway is an important pathway to promote tumor growth, and AVB-500 drug can strongly and selectively neutralize GAS6, target inhibition of tumor growth, AVB-500 in the treatment of platinum-resistant recurrent ovarian cancer, AVB-500 has shown good safety and anti-tumor efficacy
.
As well as Envida itself, it also obtained the NMPA's "new 300mg bi-weekly administration" supplement application approval in August this year, the approval of the new dosage is based on data in Japan and the United States, will reduce the frequency of drug use, through the optimization of the dosing regimen, to provide better treatment options
for cancer patients.
In the fierce competition of monoclonal antibody drugs in China, Sidi Pharma is the "first stock of chronic tumor treatment"
in the IPO of Hong Kong stocks.
The birth of more and more "first shares" indicates that there are more
opportunities for vertical segmentation in the industry.
However, how to really change the subdivision track from "concept" to "through" may be a more difficult issue
after the company goes public.
