Company establishment

Keymed Biosciences (Chengdu) Co., Ltd. was officially founded in September.

Market financing

Angel round of financing

R&D Facility

A laboratory of  500m² and R&D equipment valued at 15 million were installed.  

Subsidiary establishment

Kangnuoxing, the subsidiary of Keymed, was founded in November and responsible for the development and commercialization of innovative antibody drugs.  

Company honor

2 programs receiving funding support from National Major Scientific and Technological Special Project for “Significant New Drugs Development”during the Thirteenth Five Year Plan Period.

Program R&D

CM310 finished pilot scale production.

Base construction

The R&D pilot platform of 10000 m² was started in October.

Market financing

The company achieved Series A financing.

Pipeline

The first product was approved for clinical trials.

CM310: In July, the treatment of moderate-to-severe eosinophilic asthma was approved for clinical trials by CDE. Phase I clinical trial was initiated in August.

In November, the treatment of moderate-to-severe atopic dermatitis was approved for clinical trials by CDE.

Base construction

The clinical production site compliant with the cGMP standards of China, United States and European Union was completed and put into use in March, with a total production capacity of 1600 L.

All of the R&D production personnel and equipment moved to D2, Bio-town, Tianfu Life Science and Technology Park in May.

kangnuoxing has obtained the Drug Manufacturing License issued by the Sichuan Provincial Medical Products Administration in December.

Market financing

The company achieved Series B financing.

Pipeline

4 programs entered clinical stage and 4 programs obtained IND approval.

CM312: CM312 was approved for clinical trials in May by CDE.

CMG901: CMG901 was approved for clinical trials in October by CDE.

CM313: CM313 was approved for clinical trials in November by CDE.

CM310: The treatment of chronic rhinosinusitis with nasal polyposis was approved for clinical trials in November by CDE, and Phase II clinical trial was initiated.

Cooperation

Keymed entered into an agreement with Lepubiopharma in relation to the development and commercialization of the product CMG901.

Keymed cooperated with Mabworks on the development of CM312

Patent

CMG901 was granted an invention patent by the China National Intellectual Property Administration

Pipeline

8 programs entered clinical stage and 6 programs obtained IND approval.

CM310: The treatment of moderate-to-severe asthma was approved for clinical trials in May by CDE, and Phase II clinical trial was initiated. The treatment of moderate-to-severe atopic dermatitis in children and adolescents was approved for clinical trials in October by CDE.

CM326: The treatment of moderate-to-severe asthma was approved for clinical trials in March by CDE. The treatment of severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis was approved for clinical trials in October by CDE.

CMG901: CMG901 was approved for clinical trials in March by FDA.

CM338: the IND for the treatment of IgA nephropathy was approved in November by CDE.

CM355: CM355 was approved for clinical trials in September by CDE.

CM336: CM336 was approved for clinical trials in November by CDE.

Cooperation

Keymed entered into an agreement with CSPC in relation to the rights and interests in China (ex Hong Kong, Macao and Taiwan) of the product CM310 and CM326 in the treatment of moderate-to-severe asthma and  chronic obstructive pulmonary disease (COPD) and other respiratory system diseases.

Keyed entered into a strategic collaboration agreement with InnoCare to jointly develop one or more drug candidates in the neurology field, further deepening the R&D partnership between the two parties.

Production capacity expansion

A commercial-scale facility of 75333 M² was under construction, and phase I project finished topping out.

Financing and listing

Keymed achieved Series C financing, and was listed on the Main Board of The Stock Exchange of Hong Kong Limited on July 8.

Honor recognition

Keymed received support from Ministry of Industry and Information Technology of China ,and was recognized as a “Chengdu Enterprise Technology Center”

Patents

CM312 was granted an invention patent by the China National Intellectual Property Administration in October.

CM310 was granted an invention patent by the Federal Service for Intellectual Property of the Russian Federation in November.

Pipeline

10 programs entered clinical stage and 5 programs obtained IND approval.

Patents

CM316、CM317、CM326 and CM313 were successively granted invention patents by the China National Intellectual Property Administration.

CM310 was granted an invention patent by the Japan Patent Office.

Cooperation

Keymed entered into an agreement with InnoCare in relation to the development and commercialization of the product CMG369, and,the program CM355, approved for clinical trials in August, was under Phase I clinical trial.

Production capacity expansion

The construction of the first phase of commercial-scale facility has been completed by the end of 2022, which will provide 16,000L of manufacturing capacity. The design of all facilities is in compliance with the requirements of cGMP of China and United States.

Market support

In March, Keymed was included as eligible stocks of the Shenzhen-Hong Kong Stock Connect and multiple indices, including the Hang Seng Composite Index and the Hang Seng Hong Kong Connect Index.

In August, Keymed was included in the FTSE Global Small Cap Index ex US.

In November, Keymed was included in the MSCI China Small Cap Index.

Honor recognition

Kangnuoxing has been awarded with the titles of "National High-tech Enterprise", "Sichuan Provincial Enterprise Technology Center", and Sichuan Provincial "Specialized, Refined, Characteristic, and Innovative" SME

Pipeline

9 programs entered clinical stage and 6 programs obtained IND approval.  The NDA of  Stapokibart (CM310) was accepted by the China's NMPA and granted priority review.

CM310: 14 clinical trials have been conducted, including 4 key clinical trials. The Phase III clinical trial for the treatment of moderate-to-severe atopic dermatitis in adults in March has reached the primary endpoint, and the key Phase II/III clinical trials for the treatment of moderate-to-severe asthma has initiated. The Phase III clinical trial for the treatment of chronic rhinosinusitis with nasal polyposis in December has reached the primary endpoint.

Cooperation

Keymed Entered into a global exclusive license agreement with AstraZeneca which will receive a sales-related milestone paymentof up to $1.188bn as well as tiered royalties

Keymed Biosciences and Rona Therapeutics announce collaboration to discover and develop first-in-class siRNA therapeutics for glomerulonephritis in May.

Production capacity expansion

The Phase II project of manufacturing facility was started in November.

Digital empowerment

Accelerate Informationization and Intelligence to support innovative drug commercialization and build leading intelligent biopharmaceutical manufacturing facilities.

Honor recognition

Keymed has been awarded with the titles of "National High-tech Enterprise

Pipeline

3 NDA were accepted by the China's NMPA，and 13 programs entered clinical R&D/IND application stage.

Kangyueda^®(Stapokibart):The NDA of  Stapokibart (CM310) for the treatment of seasonal allergic rhinitis was accepted by the China's NMPA in April. The treatment of chronic rhinosinusitis with nasal polyposis was granted priority review in May and the Phase III clinical trial for the treatment of Prurigo Nodularis was initiated in May. The NDA of  Stapokibart (CM310) for the treatment of chronic rhinosinusitis with nasal polyposis was accepted by the China's NMPA in June. Stapokibart was approved for the treatment of moderate-to-severe atopic dermatitis in adults by NMPA in September(Chinese Drug Approval Number: S20240040). Stapokibart was approved for the treatment of chronic rhinosinusitis with nasal polyposis by NMPA in December, becoming the first domestic biologic for this indication.

CM313: The IND application of CM313 for the treatment of ITP was submitted in June.

CM383: The Phase I clinical trial of CM383 was initiated in June.

CM380: CM380 was approved for clinical trials by NMPA in September.

Cooperation

In July, Keymed granted Belenos the rights and interests  overseas of the drug candidates, CM512 and CM536, receiving 30.01% shareholding, upfront payment and sales-related milestone payment upto $ 185 million.

Honor recognition

Stapokibart was awarded the first prize of Beijing Science and Technology Progress Award.

Achievement display

Kangyueda® (Stapokibart): The Phase III 52 week clinical study data for the treatment of moderate-to-severe atopic dermatitis in adults were released at the 43rd EAAC1 in June 2024 and presented at the 29th Annual Meeting of Chinese Society of Dermatology. The efficacy and safety data of the Phase III 52 week clinical study for the treatment of moderate-to-severe atopic dermatitis in adults were officially published in the top international journal "Allergy" in the field of allergies and immunology in September. Multiple clinical research results were presented orally and in electronic posters at the 2024 EADV conference.

CMG901: The latest data from the Phase I clinical study for the treatment of advanced gastric cancer/gastroesophageal junction adenocarcinoma was presented at the ASCO Annual Meeting in June.

CM313: The Phase IIT study data for the treatment of ITP was published in The New England Journal of Medicine in June.

CM355: The Phase I study data for the treatment of Relapsed/Refractory Non-Hodgkin Lymphomas was released in EHA in June.

CM336: The latest data from Phase I/II clinical study for the treatment of Relapsed/Refractory Multiple Myeloma was released at the 66th Annual Meeting of the American Society of Hematology (ASH) in December.

Base construction

Building No.6: The main structure of the building finished topping out in January.

ADC pilot test project: The project was initiated in March.

Oligonucleotide pilot test project: The project was initiated in November.

Comprehensive building : The construction of comprehensive building was started in January, and main structure of the building finished topping out in December.

Brand renewal

 Keymed refreshed brand vision.

Pipeline

Kangyueda® (Stapokibart) was approved for the treatment of seasonal allergic rhinitis by NMPA, becoming the first IL-4α biologic for this indication.

Cooperation

Keymed Entered into a global exclusive license agreement with Timberlyne in relation to the potential best-in-class CD38 monoclonal antibody CM313.

Ouro Medicines has secured $120 million in financing to advance the development of CM336, a drug candidate licensed from Keymed Biosciences under a global exclusive license agreement.

Keymed and Innocarepharma entered  into a licenese agreement with Prolium in relation to the development and commercializarion of the CD20xCD20 bispecific antibody CM355 (ICP-B02)

Conference

The 2025 Academic Conference on Atopic Dermatitis Immunotherapy Innovation was held in Chengdu.