Shengnuo Pharmaceutical siRNA drugs released Phase II clinical data, domestic small nucleic acid drugs or will enter the fast lane

Aug.

Recommended reading: Shengnuo Pharmaceutical skin cancer siRNA drug Phase II clinical realization of 100% complete remission, siRNA technology or will usher in a golden decade?

In addition, in recent days, Sunno Pharma also announced that the company is promoting RNAi therapy based on the GalAhead™ delivery platform for the treatment of complement-mediated related diseases

Complement is a serum protein found in human and vertebrate serum and tissue fluid, and has enzymatic activity

In addition to STP144G, STP146G for targeted complement factor C3 and STP145G for targeted complement factor C5 developed on this platform have been fully validated

Dr.

The track is full of flowers, and research and development is constantly advancing

Sannor Medicine

In the research pipeline, the fastest progress of Sunno Pharma is its core product STP705
.

This is a small interfering nucleic acid (siRNA) therapy consisting of two siRNA oligonucleotide molecules that target inhibition of conversion growth factors -β1 (TGF-β1) and cyclooxygenase (COX-2), respectively, using a polypeptide nanoparticle (PNP) delivery system
.

The candidate has been qualified as an orphan drug for the treatment of cholangiocarcinoma and primary sclerosing cholangitis, and STP705 currently has seven clinical trials
for different indications.

▲Drug mechanism of action (Image source: official website)

On August 29, 2022, SengnoMedic announced that STP705 achieved 100% complete clearance (CR) in a Phase II clinical trial for the treatment of cutaneous basal cell carcinoma (BCC).


In addition, 5 subjects in the cohort also showed stable or better cosmetic effects, and there were no obvious skin adverse reactions during the
trial.

Currently, Shengnuo Pharma is continuing its dose-climbing trial to conduct dose studies, and is expected to receive a final report
in the first quarter of 2023.

Rainbow Bio

Ruibo Biotech is a pharmaceutical company
focusing on small nucleic acid innovation technology and research and development of small nucleic acid drugs.

Since its inception in 2007, it has received several rounds of financing, and in July 2022, it received another $40 million E1 round of financing
.

The company has established a pipeline layout
for major disease areas such as cardiovascular metabolic diseases, liver diseases, ophthalmic diseases, and rare diseases.

▲R&D pipeline (Image source: official website)

As early as 2012, Rainbow Bio and the American Quark Pharmaceutical Company jointly established "Rainbow Quark"
.

In November 2017, Rebquark announced that its globally critical II/III study QRK207, a siRNA drug candidate for optic neuroprotection, completed the first chinese subject administration
.

This is also the fastest progress of Rainbow Bio in the research pipeline
.

Tengsheng Bo medicine

Tengsheng Bo Pharmaceutical is a multinational biopharmaceutical company dedicated to the development of innovative therapies for patients' unmet needs and major public health diseases
.

Its long-acting neo-coronavirus neutralizing antibodies Ambavir monoclonal antibody and romimavir monoclonal antibody combination therapy have been commercially listed in China in July 2022, which is also the first approved new coronavirus neutralizing antibody drug
in China.

Under this "halo", Tengsheng Bo Pharmaceutical laid out BRII-835 (siRNA), BRII-179 (therapeutic vaccine) and BRII-877 (hepatitis B monoclonal antibody), based on siRNA, combined with therapeutic vaccines and/or monoclonal antibodies under the multi-pronged innovative hepatitis B treatment strategy
.

Among them, BRII-835 (VIR-2218) is the first candidate siRNA drug to target HBV developed using the latest ESC+GalNAc coupling technology, which can not only inhibit the expression of all HBV-related antigens, but also minimize off-target toxicity and improve the treatment index
.

▲R&D pipeline (Image source: official website)

Recommended reading: Innovative combination therapy helps the functional cure of chronic hepatitis B, and Tengsheng Bo medicine leads the frontier

In addition, there are also Jima gene, Xingyao Kunze Biology, etc.
have laid out the field of
RNAi therapy.

At present, a number of antisense nucleic acids (ASO) and siRNA have been approved for listing abroad, while the domestic field is still in a blank state, but there are candidate products into the middle and late clinical stages, and it is expected that there will be local products to fill the domestic gap
in the near future.

Analysis of the RNAi industry chain

In fact, the development of any track is inseparable from a healthy and virtuous circle of the industrial chain
.

The upstream of RNAi's industrial chain is the supplier of raw materials for production, including reagents, instruments, consumables, etc
.

Public data show that the cost of reagents in a single RNAi project technology accounts for about 10%-15%; Consumables account for about 5%-10%, while more than 90% of equipment depends on imports
.

However, it is clear that domestic R&D enterprises have shown a strong demand for localization of raw materials, which has also become an opportunity
for upstream enterprises to develop.

The main participants in the midstream of the industrial chain are RNAi drug manufacturers and technical service providers, which are still in the stage of technology accumulation in China, mainly in the research and development of RNAi drugs, and the development model needs to be explored
more diversified.

In addition to the leading enterprise Alnylam, pharmaceutical giants AstraZeneca and Roche have also laid out
through transactions and acquisitions.

The domestic development can also refer to the commercialization model of enterprises with rapid progress, and start commercialization while promoting clinical practice, in order to seize the opportunity
for future listing.

The application scenarios of the downstream of the industrial chain are clinical, but at present, because no products have been approved for listing in China, the indications for RNAi drugs are the priority of
enterprises in the early research and development stage.

At present, RNAi drugs for Duxen's malnutrition have been approved for marketing
.

summary

With the introduction of policies and regulations, RNAi drugs have been listed in key development areas
.

Whether it is the progress of candidate products in this field, or the gradual improvement of the industrial chain, the birth of an RNAi therapy in China should be inevitable
in the future.

At present, improving the drug delivery technology of RNAi technology, improving the rate of endocytosis escape, and discovering more new targets are important trends
in the industry.

Resources:

1.
The official website of each enterprise

2.
https://max.
book118.
com/html/2021/0331/5223233302003210.
shtm

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