Development Pharmaceutical Announces 2020 Annual Results, Procruamide Treatment of New Crown Commercialization Is Coming

Phrayton (KX-826), AR antagonist for external use

Androgenetic alopecia (China): On September 17, 2020, the company's application for a new drug research application for androgenic alopecia indications for the company's Freitan gel formulation was approved by the China National Medical Products Administration
.
On December 29, 2020, the recruitment of patients for the Phase II clinical trial of Freetalin in China has been completed
.

Androgenetic alopecia (U.
S.
): In August 2020, the company has completed the Phase Ib clinical trial of Freetalan in the U.
S.
, and the analysis and evaluation of the trial data is in progress
.

Acne (China): On September 17, 2020, the company's new drug research application for acne indications in the formulation of the company's Freitan gel formulation was approved by the China National Medical Products Administration
.

Expected milestone

In the third quarter of 2021, complete the Phase II clinical research report of Freetarin in China for androgenetic alopecia and release the data
.

In the first half of 2021, the Phase Ib clinical research report of Freetalan in the United States for androgenetic alopecia will be completed and data will be released
.

At the beginning of the second quarter of 2021, the enrollment of the first subject in the phase I clinical trial of Freetarin for acne in China will be completed
.
The phase I clinical trial is expected to be completed in 2021 .

ALK-1 (GT90001), a new anti-angiogenesis inhibitor

Metastatic hepatocellular carcinoma (Taiwan, China): The company is conducting a phase II clinical trial of ALK-1 monoclonal antibody and Nivolumab for the treatment of metastatic hepatocellular carcinoma in Taiwan, China
.
In January 2021, the company announced the Taiwanese clinical trial data of ALK-1 monoclonal antibody and Nivolumab combined with second-line treatment of metastatic hepatocellular carcinoma on ASCO GI.
The results showed that the objective remission rate was 40% and the safety was good
.

Metastatic hepatocellular carcinoma (U.
S.
): On February 11, 2021, the U.
S.
FDA approved ALK-1 monoclonal antibody combined with Nivolumab for the second-line treatment of advanced hepatocellular carcinoma in a Phase II clinical trial
.

Ditoceti (GT0486), PI3K/mTOR signaling pathway inhibitor

Metastatic solid tumors (China): It has been approved by China's IND in August 2019.
Ditoxit is the second-generation mTOR inhibitor, which can inhibit both mTORC1 and mTORC2.
It is currently in the phase I clinical trial dose climbing stage
.

Expected milestone

The Phase I clinical trial of GT0486 in China will be completed in 2021
.

GT1708F (Hedgehog/SMO inhibitor), hedgehog signal transduction pathway inhibitor

Leukemia and Basal Cell Carcinoma (China): It has been approved by China's IND in February 2020, and is currently in the phase I clinical trial dose climbing stage
.

Basal cell carcinoma (U.
S.
): In November 2020, it was accepted by the U.
S.
FDA for indications for basal cell carcinoma
.

Expected milestone

The phase I clinical trial of GT1708F for leukemia in China will be completed in 2021
.

GT20029, PROTAC-AR degradation agent

Androgenetic alopecia and acne (China): In February 2021, the IND was accepted by the CDE for the treatment of androgenetic alopecia and acne.
It is the world's first external AR degradation agent based on PROTAC technology
.

Expected milestone

The Phase I clinical trial of GT20029 in China will be launched in 2021
.

In addition to the above-mentioned clinical-stage drugs under research, the company is developing a variety of pre-clinical-stage drugs, including c-Myc inhibitors for the treatment of blood cancer and PD-L1/TGF-β dual target antibodies for the treatment of various solid tumors, etc.

.

Production base

Suzhou: The company’s first GMP factory is located at No.
20 Songbei Road, Industrial Park, Suzhou City, Jiangsu Province.
It covers an area of ​​about 20,000 square meters.
It will officially operate in August 2020 for the commercial production of Prokalamide and Furui Production of Tahn clinical drugs
.
In November 2020, the factory obtained the "Pharmaceutical Production License"
.

Pinghu: An API and preparation production base project located in Pinghu County, Zhejiang Province, covering an area of ​​approximately 40,000 square meters
.
The design of the project has started, and construction is expected to start in the third quarter of 2021, and the construction will be completed before the end of 2022
.

Commercial cooperation

Freedom's commercialization cooperation

In June 2020, the company and JD Health signed a strategic cooperation framework agreement, and the two parties carried out in-depth cooperation on the marketing of Frey Taen's online pharmaceutical retail platform JD Pharmacy operated by JD Health
.

In March 2020, the company signed a cooperation agreement with Sinopharm Holding Co.
, Ltd.
, and will carry out all-round cooperation in product design, business channel expansion, terminal services and other aspects
.

Cooperation with Corning Jerry

In July 2020, the company and Corning Jerry reached a cooperation to jointly promote the global clinical research of ALK-1 monoclonal antibody combined with recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046 in the treatment of hepatocellular carcinoma and other tumors
.

Cooperation with American Gensun

In August 2020, the company and Gensun of the United States signed an exclusive license agreement for the PD-L1/ TGF-β dual target antibody GS19, and Pioneer Pharmaceuticals obtained the exclusive right to clinical development and commercialization of GS19 in Greater China
.

Cooperation with Maibury

In September 2020, the company signed a strategic cooperation agreement with Maibury International Biopharmaceutical Co.
, Ltd.
, and the two parties launched a full range of cooperation on the development and production of biological macromolecular drugs
.

Cooperation with Pumis

In October 2020, the company and Promis Biotechnology (Zhuhai) Co.
, Ltd.
reached a strategic cooperation agreement on the development of biological drugs
.

Global layout

2020 full-year financial performance

As of December 31, 2020, the company’s research and development costs increased by RMB 114.
8 million or 53.
6% from RMB 214 million for the twelve months ended December 31, 2019 to RMB 114.
8 million or 53.
6% as of December 31, 2020.
RMB 328.
8 million for two months
.
The main reason for the increase in R&D expenditure is that the company continues to increase R&D investment, and a number of clinical trials of the product pipeline have advanced to the later stage, and the listing application is about to be submitted; in addition, the company has also expanded the scale of R&D and clinical operations staff, as well as equity incentive plan expenditures
.

As of December 31, 2019, the company’s cash and cash equivalents amounted to RMB 195.
5 million.
As of December 31, 2020, it was RMB 1389.
0 million, an increase of RMB 1193.
5 million.
The increase was mainly due to the IPO proceeds.
And bank loans
.

As of December 31, 2020, our utilised bank financing was RMB 218.
5 million, and our unutilized bank financing was RMB 101.
0 million
.