In October, many well-known pharmaceutical companies introduced new drugs. What are their highlights?

Introducing products from outside is one of the important ways for biomedical companies to expand their product pipelines and explore more innovative therapies
.
According to incomplete statistics, in October 2021, at least eight Chinese biopharmaceutical companies have reached agreement on new drug introduction cooperation, including Shanghai Pharmaceuticals, Luoxin Pharmaceutical, Huadong Pharmaceutical, Yehui Pharmaceutical, China Resources Double Crane, Hansen Pharmaceutical, etc.

1.
Introducer: Shanghai Pharmaceuticals

Authorized party: KoBioLabs

Mechanism of drug action: single strain of live bacteria drugs

On October 28, Shanghai Pharmaceuticals announced that it will obtain a new probiotic drug KBL697 and KBL693 project from KoBioLabs for a transaction amount of no more than US$107.
25 million (excluding sales commissions) to develop, produce, register, distribute, sell, and market in China.
The right to promote and sublicense includes all indications of KBL697 and KBL693 as medicines
.

KBL697 and KBL693 are two single-strain live bacteria medicines developed by KoBioLabs that have entered the clinical stage and are used to treat a variety of immune system diseases
.
Data at this stage show that KBL697 and KBL693 have shown good potential for psoriasis and asthma, and these two new probiotics also have good safety, which is good for chronic immune system diseases that are prone to recurrent attacks and need long-term control.

2.
Introducer: Saishen Pharmaceutical

Authorized party: Mabylon

Mechanism of drug action: TDP-43 targeted drugs, APOE targeted drugs, etc.

On October 26, SciNeuro Pharmaceuticals and Mabylon announced the establishment of a multi-project cooperation and licensing agreement.
The two parties will jointly discover and develop differentiated biological therapies to treat neurological diseases.
SciNeuro Pharmaceuticals will have the right to be in Greater China The district develops and commercializes the resulting products, and can choose to extend such rights to the world
.

Saishen Medicine focuses on the field of central nervous system diseases, and announced in December 2020 that it will officially set sail and complete a US$100 million Series A financing
.
According to the press release, Saishen Medicine and Mabylon will cooperate on multiple targets, including TAR DNA-binding protein 43 (TDP-43) and Apolipoprotein E (APOE).

3.
Introduced party: Luoxin Pharmaceutical

Authorized party: Marinomed Biotech

Mechanism of drug action: Hormonal nasal spray

On October 21, Luoxin Pharmaceuticals announced that its subsidiary Shandong Luoxin will obtain the exclusive development of Budesolv budesonide solution nasal spray from Austria's Marinomed Biotech in Greater China (including China, Hong Kong, Macau, and Taiwan).
The right to production and commercialization
.
According to the terms of the license agreement, Shandong Luoxin will pay Marinomed a total down payment of US$2 million, and pay milestone payments of no more than US$20 million based on R&D milestones and sales milestones

Budesolv is suitable for the treatment of allergic rhinitis.
It is a new type of glucocorticoid budesonide.
It belongs to the hormone nasal spray.
It is not currently on the market in China or abroad
.
Budesolv is a water-soluble nasal spray developed based on Marinomed’s proprietary technology platform Marinosolv.

4.
Introducer: China Resources Double Crane

Authorized party: Ligand

Mechanism of drug action: RNA polymerase inhibitor

On October 20th, China Resources Double Crane's Innovation Division and Ligand Pharmaceuticals of the United States reached an agreement to jointly develop an oral small molecule RNA polymerase inhibitor drug for the treatment of COVID-19.
China Resources Double Crane will be entitled to this drug in Asia in the future Exclusive development and commercialization rights in major areas
.
According to the press release, this project is the second cross-border innovative drug project of China Resources Double Crane Innovation Division since its establishment at the beginning of the year, and it is still in the preclinical research stage

According to the press release, the drug uses Ligand's BEPro technology
.
BEPro technology is the latest generation of prodrug technology developed by Ligand, which is suitable for improving the oral administration efficacy of nucleoside antiviral drugs

5.
Introducer: Huadong Medicine

Authorized party: Ashvattha Therapeutic

Mechanism of drug action: Hydroxy dendrimer therapy (HDTs)

On October 19, Huadong Medicine's wholly-owned subsidiary Sino-American Huadong and Huadong Medicine Investment Holdings (Hong Kong) Co.
, Ltd.
(referred to as "Huadong Medicine Investment Holdings") and Ashvattha Therapeutic signed an equity investment agreement and an exclusive product license agreement
.
According to the agreement, Huadong Pharmaceutical Investment Holdings will invest in phased investment subscriptions for the Series B preferred shares issued by Ashvattha

Ashvattha is an innovative biopharmaceutical company focused on hydroxy dendrimer therapies (HDTs).
Its scientific research team is based on the interdisciplinary translational research of dendrimers, combining active pharmaceutical ingredients (API) or imaging agents with hydroxyl Dendrimers (HD) are connected to form a patented new drug, which can achieve precise treatment by targeting disease cells, which has good clinical value and application prospects
.
This time, Huadong Medicine introduced 8 products under research from Ashvattha Company, covering the treatment fields of tumors, metabolic comorbidities and inflammations
.
Among them, one product has entered Phase 2 clinical trials in the United States, and two products are scheduled to submit IND applications in the United States in the first quarter of 2022
.

6.
Introducer: Hansen Pharmaceutical

Authorized party: Silence Therapeutics, OliX Pharmaceuticals

Mechanism of drug action: siRNA therapy

On October 15, Hansen Pharmaceuticals announced that it has entered into an exclusive license cooperation agreement with Silence Therapeutics plc.
The two parties will use the latter's exclusive mRNAi GOLD™ platform to cooperate in the development of siRNA targeting three targets
.
According to the announcement, this cooperation involves more than 1.
3 billion U.
S.
dollars
.
Among the three target products of this cooperation, for the first two targets, Hansen Pharmaceuticals will have the exclusive right to license in China (including Hong Kong, Macau and Taiwan) after completing the Phase 1 clinical study.
; For the third target, Hansen Pharmaceuticals will obtain the exclusive right to license the global rights when applying for a new drug clinical trial (IND)
.

On October 12, Hansen Pharmaceuticals and OliX Pharmaceuticals jointly announced the signing of a licensing and cooperation agreement to discover, develop and commercialize siRNA therapies for key targeted indications in China
.
Hansen Pharmaceuticals will have the exclusive commercial rights of these therapies in China (including Hong Kong, Macau and Taiwan), and OliX will have rights in other regions outside the region
.
OliX will receive a down payment of US$6.
5 million, as well as a maximum of US$450 million based on important milestones and franchise license sharing
.
According to the agreement, OliX will use GalNAc-asiRNA platform technology to discover lead drugs and ensure the development of drug candidates for liver-related cardiovascular, metabolic and other disease targets
.
Asymmetric small interfering RNA (asiRNA) technology is a new generation of RNA interference technology that effectively regulates gene expression
.

7.
Introduced party: Yehui Pharmaceutical

Authorized party: Sutro Biopharma

Mechanism of drug action: Antibody-conjugated drug (ADC) targeting CD74

On October 12, Sutro Biopharma announced the authorization of Yehui Pharmaceutical to develop and commercialize ADC STRO-001 targeting CD74 in Greater China (including China, Hong Kong, Macau and Taiwan) for the treatment of blood cancer patients
.
According to the press release, in the clinical phase 1 dose escalation study, STRO-001 showed encouraging early efficacy signals and good tolerability in relapsed/refractory hematological malignancies
.
Currently, STRO-001 is undergoing a phase 1 clinical trial for patients with advanced B-cell malignancies and has been granted orphan drug designation by the US FDA for the treatment of multiple myeloma
.

According to the terms of the agreement, Yehui Pharmaceutical can choose to obtain the exclusive right to develop and commercialize STRO-001 in Greater China
.
Yehui Pharmaceutical will seek the clinical development, registration and commercialization of STRO-001 in multiple indications.
The proposed development indications include non-Hodgkin's lymphoma, multiple myeloma and leukemia
.
Sutro will retain the global development and commercial rights of STRO-001 outside of Greater China, including the United States
.
Yehui Pharmaceuticals will make a down payment of US$4 million to Sutro
.
The total potential payments related to option exercise, drug development, registration and commercial milestones are up to US$200 million .
After commercialization, Sutro will obtain double-digit sales commissions with different gradients based on STRO-001's annual net sales in Greater China
.

8.
Introducer: Shanghai Pharmaceuticals

Authorized party: Shengnuo Pharmaceutical

Mechanism of drug action: potassium ion competitive acid blocker (P-CAB)

On October 8, Shanghai Pharmaceuticals announced that it had obtained Guizhou Shengnuo Biotechnology Co.
, Ltd.
(hereinafter referred to as "Shenuo Pharmaceutical") new acid inhibitor X842 raw materials and preparations for an amount of no more than RMB 690 million (excluding sales commissions).
Exclusive consignment production and industrial sales rights for all indications in China (including Hong Kong, Macau and Taiwan)
.

According to public information, X842 was jointly developed by SINOPHARM and Ciclus Pharma, SINOPHARM has obtained the development, production and commercialization rights in Asia
.
X842 is a new-generation potassium ion competitive acid blocker (P-CAB) oral drug.
It can competitively block the potassium ion activity in HK-ATPase and inhibit gastric acid secretion.
It has rapid onset of action, strong acid suppression and Long-lasting, less adverse reactions and other advantages
.
Compared with Proton Pump Inhibitor (PPI), X842 has a longer half-life and uses a different mechanism of action to regulate and control the release of gastric acid
.
This novel method provides a good way to relieve symptoms and promote the healing of the inner wall of the hairy mucosa
.

The results of Phase 1 clinical trials of X842 in Sweden and China show that the drug has good safety and tolerability, has a rapid onset of action, and can inhibit gastric acid secretion for a long time in a dose-dependent manner
.
Currently
.
Shengnuo Medicine has launched a domestic Phase 3 clinical study of X842 for reflux esophagitis, and plans to conduct clinical studies for two indications of Helicobacter pylori and duodenal ulcer
.

We look forward to the smooth progress of follow-up research on these innovative therapies, which will bring more and better treatment options to patients
.