Kelun Pharmaceutical released the third quarterly report of 2022 on the evening of October 30, and the company's total operating income in the first three quarters was 13.
858 billion yuan, a year-on-year increase of 9.
2%; The net profit attributable to the parent was 1.
411 billion yuan, a year-on-year increase of 66.
3%.
For the reasons for the performance growth, the company once said in the performance forecast that the company made every effort to expand the infusion and non-infusion product market, continued to optimize the product structure, increased the sales of newly approved products, and increased profits year-on-year; The market price of the main products of Yili Chuanning Biotechnology Co.
, Ltd.
, a holding subsidiary, rose and profits increased
year-on-year.
In addition, the company's innovative drug SKB264 and early clinical biomolecular tumor project B are exclusively licensed to MSD for a fee, increasing revenue and profit
.
Kelun Pharmaceutical Co.
, Ltd.
has been labeled as a traditional pharmaceutical company, and in recent years, under the general trend of centralized procurement and price reduction, the traditional generic drug business has been generally affected, which has strengthened the company's determination
to transform into innovative drugs.
Judging from the report card of the third quarterly report, the transformation of Kelun Pharmaceutical after centralized procurement has achieved initial results
.
In terms of research and development, the company also continues to increase investment
.
In the first three quarters, Kelun Pharmaceutical's R&D expenses were 1.
204 billion yuan, an increase of 15 million yuan compared with 1.
189 billion yuan
in the previous period.
It is worth mentioning that the company's sales expenses in the first three quarters of this year were 3.
354 billion yuan, a decrease compared with 3.
767 billion yuan in the previous period, which shows that the company has entered a state of innovation transformation of
"heavy research and development, light sales".
Up to now, Kelun Pharmaceutical has 31 new drugs in the declared clinical stage and above, including 19 Class 1 new drugs, covering tumor, autoimmunity, anesthesia and analgesia, cardiovascular, liver disease and other disease fields, involving PD-L1, TROP-2, JAK, HER2, RET, LAG-3, CLDN18.
2 and other targets, covering small molecules, monoclonal antibodies, bispecific antibodies, ADCs and other fields
.
From the perspective of progress, among the 19 Class 1 new drugs, the fastest progress is tetlimab injection, which is the first Class 1 new drug declared for marketing by Kelun Pharmaceutical, and the first PD-L1 monoclonal antibody
submitted for NDA for nasopharyngeal carcinoma indications in the world.
On November 19, 2021, the drug was accepted by CDE for recurrent or metastatic nasopharyngeal carcinoma
that has previously received second-line or above chemotherapy failures.
The drug is expected to be approved by
the end of 2022 or early 2023.
Nasopharyngeal carcinoma is a very high incidence of otolaryngology malignant tumors, is one of the common malignant tumors in China, patients are often found in the middle and advanced stages, the majority of patients have unmet clinical treatment needs
.
It is reported that Tellimab injection is an innovative humanized monoclonal antibody targeting PD-L1 independently developed by Kolumbote, which specifically binds to PD-L1 to promote the proliferation of T cells and the secretion of cytokines, and enhance tumor immune response
.
As of the date of submission of the marketing application, no domestic PD-L1 monoclonal antibody with independent intellectual property rights has obtained this approval
.
The current tetly mab patent is held by Colombotel, and the rights outside China were licensed to Harbour Biomed
in 2018.
Followed by SKB264 for injection is in the phase III clinical stage, the product is an ADC drug targeting human trophoblast cell surface antigen 2 (TROP-2), which is the first domestic TROP2-ADC approved for clinical trials, and was approved as a breakthrough therapy for CDE in July 2022 for the treatment of advanced or metastatic triple-negative breast cancer
.
In the United States, the product has achieved double reporting in China and the United States, and is undergoing phase II clinical trials
in the United States.
In addition, a number of oncology drugs, including A166 for injection, KL070002 capsules, KL-A289 injection, SKB337 injection, KL340399 injection, etc.
, are in phase II and phase I clinical stage
.
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