2023 China Pharma License-in Deals: BeiGene, Huadong Medicine, Betta Pharmaceuticals and Others Bring Innovative Therapies to Market

▎Edited by the WuXi AppTec content team

Importing products from outside is one of the important ways for innovative drug companies to expand their product pipelines. According to incomplete statistics, in 2023 Chinese innovative drug companies completed more than ten license-in deals.Authorized Collaboration, involving the introduction of productsAnti-CD19 in-situ CAR Project, BiDAC Degrader, Topical PDE4 Inhibitor, Long-acting PCSK9 Inhibitor, CAR-NK Cell Therapy...and other innovative products. In this article, let's take a look at which companies in China have reached license-in authorization cooperation agreements and which patients these introduced products are expected to benefit?（The statistical scope of this article's license-in authorization cooperation is: Chinese companies introducing the relevant rights of overseas companies' drugs under research, excluding technology/platform-type authorization cooperation and purely commercial promotion-type authorization cooperation.）

Scan the QR code below to obtain the PDF file of "2023 China New Drug Licensing Collaboration cases".。

Licensor: Orna Therapeutics

Introducer: Simnova

Product Name: ORN-101, etc.

Mechanism of Action: Anti-CD19 in situ CAR Project, etc.

In January 2023, Simnova and Orna Therapeutics (referred to asOrna TherapeuticsSimnova announced that it has reached a cooperation agreement and will be responsible for Orna.In Vivo Cell Therapy Products Developed Using Breakthrough Circular mRNA Technology (oRNA)Development and commercialization in the Greater China region within the oncology field, including the leading asset from Orna's pipeline.Anti-CD19 in situ Chimeric Antigen Receptor T-cell Technology (isCAR) ProjectORN-101。

According toOrnaPress Release: The company's proprietary isCAR technology consists of two components: meticulously designed oRNAs expressing CAR, and customized lipid nanoparticles (LNPs) aimed at delivering oRNA to immune system cells.ORN-101 is an in situ CAR therapy that uses LNP to deliver circular RNA, modifying immune cells within the patient’s body.The potential advantage of this technology is that it does not require patients to undergo treatment to clear lymphocytes from their bodies and allows for reliable dose control, overcoming multiple barriers associated with ex vivo CAR-T cell therapy.

Authorizing Party: VFMCRP

Introducer: WeCare Pharmaceuticals

Product Name:difelikefalinInjectable

Mechanism of Action: KOR Agonist

In January 2023, WinnerMed and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced the signing ofLong-term exclusive license agreement for the development and commercialization of Korsuva (difelikefalin) injection. VFMCRP will receive an upfront payment and additional milestone payments upon market approval, while Winner Pharmaceuticals will receiveKorsuvaExclusive rights for the development and commercialization of injectables, to be used inMainland ChinaTheTreatment of Chronic Kidney Disease-Associated Pruritus in Dialysis PatientsWJ Pharmaceuticals also has the right to expand the authorized regions to Hong Kong, Macao, and Taiwan areas of China.

VFMCRP is a joint venture between CSL Vifor and Fresenius Medical Care. The active substance in Korsuva injection, difelikefalin, is aKappa Opioid Receptor (KOR) Agonist, has been approved in the United States, the European Union, and other regions for the treatment of adult hemodialysis patients with chronic kidney disease-associated pruritus. The productThe hydrophilic peptide structure limits its entry into the central nervous system (CNS), distinguishing it from kappa opioid agonists with central activity.It does not cause respiratory depression.

Licensor: PhaseBio Pharmaceuticals Inc

Introducer: CORXEL

Product Name: PB6440 (Currently referred to as JX09)

Mechanism of Action: Highly Selective Aldosterone Synthase Inhibitor

In February 2023, CORXEL announced a global acquisition of an innovative product in the cardiovascular field. Through an asset purchase, CORXEL will acquire the global rights to PB6440, a product under development by PhaseBio Pharmaceuticals. PB6440 (currently referred to as JX09) isA New Generation of Highly Selective Aldosterone Synthase Inhibitors, addressing unmet treatment needs in the cardiovascular field, including hypertension. In vitro studies have shown,JX09Its selectivity for aldosterone synthase is more than 300 times that of cortisol synthase. It can also reduce aldosterone levels by >90% without increasing adrenal steroid precursors, which is a common side effect of similar products.

Authorizing Party: Onconic Therapeutics

Introducer: Livzon Pharmaceutical Group Inc.

Product Name: Zastaprzan

Mechanism of Action: P-CAB

In March 2023, Livzon Pharmaceutical Group Inc. announced a collaboration with Onconic Therapeutics (referred to asOnconic TherapeuticsRegarding the latter, Zastaprzan signed an exclusive license agreement in Greater China. Livzon Pharmaceutical Group Inc. will pay Onconic Therapeutics an upfront licensing fee of $15 million, technology transfer fees, and corresponding development and sales milestone payments totaling no more than $112.5 million.Zastaprazan is a self-developed product by Onconic Therapeutics.Innovative Potassium-Competitive Acid Blocker (P-CAB), is currently conducting a Phase 3 clinical trial in South Korea for erosive esophagitis. The productWith efficacyFast, excellent acid suppression effect, long-lasting action, and few adverse reactions.，Future applications may be expanded to the treatment of duodenal ulcers, Helicobacter pylori infections, and non-erosive gastroesophageal reflux disease.

Licensor: Acorda Therapeutics

Introducer: Chance Pharmaceuticals

Product Name: Inbrija

Mechanism of Action: Inhaled Levodopa Powder

In May 2023, Chance Pharmaceuticals and Acorda Therapeutics (referred to asAcorda TherapeuticsAnnouncementInbrija (Levodopa Inhalation Powder)Chance Pharmaceuticals and Acorda Therapeutics have reached a collaboration for the clinical application of Inbrija in the Greater China region (including mainland China, Hong Kong, Macao, and Taiwan). Chance Pharmaceuticals will be responsible for advancing the clinical application of Inbrija in the Greater China region. Additionally, Chance Pharmaceuticals will pay Acorda Therapeutics an initial payment of $2.5 million, along with potential milestone payments of up to $141 million in the future. Inbrija is a powder inhaler.Can be administered via inhalation.Fast-Acting, helping patients quickly manage "off" episodes, thereby improving their quality of life. This productHas been approved for marketing in the United States and the European Union, for patients receiving levodopa-decarboxylase inhibitor treatment.Intermittent Treatment During "Off" Periods in Adult Patients with Parkinson's Disease。

Licensor: C4 Therapeutics

Introducing Party:Betta Pharmaceuticals

Product Name: CFT8919

Mechanism of Action: BiDAC Degrader

In May 2023, Betta Pharmaceuticals announced a collaboration with C4 Therapeutics to introduceAllosteric BiDAC DegradersCFT8919 Project. Betta Pharmaceuticals will initially pay C4 Therapeutics $35 million, with potential milestone payments totaling up to $357 million, as well as sales royalties at an agreed percentage for CFT8919 in the licensed region. Additionally, Betta Pharmaceuticals will be responsible for the development, manufacturing, and commercialization of CFT8919 in Greater China.CFT8919 is an orally bioavailable allosteric BiDAC degrader.. In preclinical studies, the productEGFR L858RActive in in vitro and in vivo models of non-small cell lung cancer (NSCLC),Can target a wide range of on-target resistance mutations and has intracranial activity, with the potential to prevent or treat brain metastases in patients.. In December 2023, the drug had already been in China.Approved for Clinical Use。

Licensor:Arcutis Biotherapeutics

Introducing Party: Huadong Medicine

Product Name:Roflumilast Cream and Foam

Mechanism of Action:PDE4 Inhibitor

In August 2023, Huadong Medicine, a wholly-owned subsidiary of Huadong Medicine, and Arcutis Biotherapeutics (referred to asArcutis BiotherapeuticsAnnounced the signing of an exclusive license agreement,Huadong Medicine will obtainNew Generation Phosphodiesterase-4 (PDE4) InhibitorRoflumilast Topical Formulations (including RoflumilastCreamZoryve and RoflumilastFoaming AgentARQ-154)Greater ChinaAndSoutheast AsiaThe exclusive license, including development, registration, production, and commercialization rights.Arcutis Biotherapeutics will receive an upfront payment of $30 million, registration and sales milestone payments of up to $64.25 million, etc.Zoryve CreamApproved by the U.S. FDA for the treatment ofPlaque Psoriasis (including intertriginous areas) in patients aged 12 years and older, andFor the topical treatment of plaque psoriasis in children aged 6-11.ARQ-154 was alsoDecember 2023Approved by the FDA,For the treatment of adult and pediatric patients aged 9 years and aboveSeborrheic Dermatitis。

Authorizing Party:MC2 Therapeutics

Introducing Party: Huadong Medicine

Product Name:Wynzora Cream

Mechanism of Action:Fixed-Dose Combination

In August 2023, Huadong Medicine once again announced that it had signed a cooperation agreement with MC2 Therapeutics A/S's wholly-owned subsidiary (MC2 Company), obtaining the latter's products for use.Wynzora Cream for the Treatment of Plaque PsoriasisThe exclusive development and commercialization rights in Greater China (including mainland China, Hong Kong, Macao, and Taiwan regions). MC2 Therapeutics will receive upfront and registration milestone payments of up to $16 million, as well as sales milestone payments of up to $36 million.Wynzora Cream isA fixed-dose combination of calcipotriol and betamethasone has previously been approved by the FDA for the topical treatment of adult plaque psoriasis, including scalp psoriasis.. This product utilizes MC2 Therapeutics' PAD drug delivery system, making it a convenient-to-use aqueous cream.

Licensor:LIB Therapeutics

Introducing Party:HASON

Product Name:Wynzora Cream

Mechanism of Action:Long-acting PCSK9 Inhibitor

In September 2023, HASON and LIB Therapeutics (abbreviated asLIB Therapeutics Inc.Jointly announced the reaching of a licensing agreement. HASON has obtained the exclusive rights to develop and commercialize leraldalcibep in Greater China, developed by LIB Therapeutics. LIB Therapeutics will receive a $20 million upfront payment and is eligible to receive up to $305 million in additional clinical, regulatory, and sales milestone payments. Lerodalcibep fusion protein is aThird-Generation Long-Acting PCSK9 Inhibitor, which requires only one subcutaneous injection per month with a smaller injection volume, helping to reduce adverse reactions at the injection site and immunogenicity.November 2023,LIB Therapeutics Inc. announced the completionLerodalcibep for Cardiovascular DiseasesThe global Phase 3 study is planned to submit the product's marketing application to the FDA in the first half of 2024.

Authorizing Party:Kezar Life Sciences

Introducing Party:Everest Medicines

Product Name:Zetozomib

Mechanism of Action:Immunoproteasome Inhibitor

In September 2023, Everest Medicines announced its collaboration with Kezar Life Sciences (hereinafter referred to asKezar Life SciencesSign a cooperation and authorization agreement to develop and commercialize the latter in Greater China, South Korea, and parts of Southeast Asia.Immunoproteasome InhibitorZetomipzomib. According to the terms of the agreement, Kezar Life Sciences is entitled to a $7 million upfront payment, as well as clinical and commercial milestone payments of up to $125.5 million.Unlike the traditional direct immunosuppressant action,ZetozomibCan modulate innate and adaptive immune responses, thereby reducing inflammation-induced organ damage.. The productPossibleDevelopment for the treatment of a series of autoimmune diseases, including lupus nephritis and systemic lupus erythematosus。Everest Medicines plans to jointly advance the product's treatment with Kezar Life Sciences.Lupus NephritisThe global Phase 2b study.

Authorizing Party:Senti Biosciences

Introducing Party:Shenglin Biomedical

Product Name:SENTI-301A

Mechanism of Action:CAR-NK Cell Therapy

In November 2023, Shenglin Biomedical announced its collaboration with Senti Biosciences (referred to asSenti BioCompany)Solid Tumor Treatment ProductsSENTI-301A Reaches New Strategic Collaboration for Clinical Development in China. Shenglin Biomedical will lead the clinical development, operations, and production of SENTI-301A. Senti Bio retains all commercial rights to SENTI-301A outside mainland China, Hong Kong, Macao, and Taiwan. Upon achieving the anticipated results, Senti Bio is eligible to receive up to $156 million in milestone payments and tiered royalties.

Public information shows that Shenglin Biomedical is committed to developing intelligent CAR immune cell therapies for the treatment of refractory solid tumors. SENTI-301A is aOff-the-shelf CAR-NK cell therapy derived from healthy donor sources, specifically designed for the treatment of tumors expressing GPC3. The product also incorporatesCalibrated Release Interleukin-15 (crIL-15), a multifunctional immunostimulatory payload designed to simultaneously stimulate surrounding immune cells, promoting the expansion, persistence, and tumor-killing ability of CAR-NK cells.

Authorizing Party:Ensem Therapeutics

Introducing Party:BeOne Medicines

Product Name:ETX-197

Mechanism of Action:CDK2 Inhibitor

On November 21, BeOne Medicines and Ensem Therapeutics jointly announced a licensing cooperation agreement, under which BeOne Medicines obtained aAn oral cyclin-dependent kinase 2 (CDK2) inhibitor under research, with an IND application to be submitted soon.Onconic Therapeutics has obtained the global exclusive license rights to ETX-197. Onconic will receive an upfront payment and is eligible to receive up to $1.33 billion in total transaction payments.OnwardMed is a new drug R&D company incubated by CBC Group in 2021, which is developing innovative small-molecule precision oncology therapies. According to a press release from BeOne Medicines, OnwardMed's CDK2 inhibitor complements BeOne Medicines' self-developed CDK4 inhibitor, which is currently in Phase 1 clinical trials, and is expected to improve the therapeutic effects of existing CDK4/6 inhibitors in specific breast cancer patients.

In the research and development of innovative drugs, collaboration plays a crucial role. In addition to the aforementioned partnerships, many Chinese innovative drug companies reached license-out authorization deals and other types of collaborations in 2023. Due to space limitations, this article will not introduce them one by one. Looking forward to future collaborations.Can accelerate the research process of innovative therapies, benefiting patients worldwide sooner!

If you want to learn more about licensing cooperation cases, please scan the QR code below, youWill receive content compiled by the WuXi AppTec team"2023 China New Drug Licensing Collaboration cases" PDF file。