Kelun Pharmaceutical's net profit increased by 142.96% in the first half of the year, 12 innovative drug pipeline progress disclosures

On August 25, Kelun Pharmaceutical released a semi-annual report

Sales of newly approved generic drugs in the first half of the year

In the first half of 2021, the total sales amount of Kelun's new medicines segment was 1.

(1)Balote (escitalopram oxalate tablets) and other central nervous products

In 2021, affected by the repeated new crown epidemic and concentrated purchases, the anti-depressant market in China will drop by 1% month-on-month (in terms of money)

In the third round of national centralized procurement, Xitai Le (citalopram hydrobromide tablets) won the bid, and the winning provinces include 15 provinces including Guangdong, Zhejiang, Jiangsu, Shandong and other major economic provinces, and cooperate with Bailuo Special.

(2) Asda (Dapoxetine Hydrochloride Tablets) and other male products

In May 2020, Kelun Pharmaceutical's Axida (Dapoxetine Hydrochloride Tablets) was approved for marketing, and won the bid in the third round of collection in November 2020.

In July 2020, the company added a blockbuster product in the field of andrology, Iyueda (vardenafil hydrochloride), which was the first imitation product in China to be listed.

(3) Parenteral nutrition infusion products

In the first half of the year, the company's key varieties of parenteral nutrition infusion products increased their sales by 20.

(4) Keruishu (Parecoxib Sodium for Injection)

Keruishu, as the company's early stock product, was affected by centralized procurement.

12 innovative drug pipelines, the latest progress announced

The Kelun innovation pipeline has 85 research projects (38 innovative small molecules and 47 biotech drugs), focusing on tumors.

Currently, there are 14 clinical projects in the innovative clinical research phase, 13 projects in the pre-clinical development phase, and more than 50 projects in the drug discovery phase

The latest developments of key innovative drug products that have entered or are about to enter the clinic are as follows:

1.

A167 is the first innovative project of PATEO Biotech to enter the application stage.

The second proposed indication for nasopharyngeal carcinoma was enrolled on January 13, 2021.

The clinical trial of A167+ Zibai for triple-negative breast cancer (TNBC) was held on April 15, 2021, and the launch of 3 centers has been completed

2.

A166 adopts a new generation of ADC technology to stabilize linker coupling antibodies and toxins, reduce the toxin detachment rate, improve tolerance and safety, and thereby improve drug efficacy

At present, A166 has obtained clinical research data of two dose expansion arms, showing that it has potential better than T-DM1 but not inferior to DS-8201 data, and the overall tolerability and safety are good; the first indication for HER2+ breast cancer has passed two A proof-of-concept of a dose expansion arm, and the official response summary of the key phase II CDE consultation was obtained on June 17, and the key phase II clinical trial of A166 will be launched quickly
.

Expanded indications include NSCLC, urothelial cancer, colorectal cancer and gastric cancer.
Among them, NSCLC and urothelial cancer have been enrolled in the group.
The colorectal and gastric cancer plans have been finalized, and the project ethics work is in progress.
It is expected to start in Q4 2021
.
In addition, A166 has begun research and demonstration of new directions such as HER2+ breast cancer 2-line Phase III RCT, combination medication and neoadjuvant therapy in terms of overall strategy
.

3.
A264TROP2-ADC

A264 has identified two phase II extended doses (4mg/kg and 5mg/kg)
.
The first indication of triple-negative breast cancer (TNBC) has now completed the enrollment of the first extended dose (4mg/kg) patients, a total of 23 patients have been enrolled, and the efficacy data will be closely followed; the second extended dose (5mg/kg) is in progress.
) Patients were enrolled in the group and progressed according to the nodes, and 9 cases have been enrolled
.
Preparing for the CDE consultation at the end of the year for this indication
.

The first back-up indication for ovarian cancer Phase II expansion: In the start-up phase of the sub-centers, 50% of the sub-centers have been activated
.
According to the preset node, the first entry into the group was achieved in July
.

Other indications (gastric cancer, SCLC, NSCLC) Phase II expansion: the layout of sub-centers is being investigated, and a small sample expansion is about to be launched to explore efficacy signals
.

Phase I data from China and the United States show that the overall tolerance is good, showing efficacy trends in breast, ovarian, and gastric cancer; PK data shows that the second dose is the same as the target ADC drug (IMMU-132) clinically approved dose The exposure level of the drug is similar, and the risk of over-the-counter medicine is basically released
.

4.
A315CLDN18.
2-ADC

The IND application materials are being prepared and are expected to be submitted by the end of August
.

5.
A140EGFR monoclonal antibody (cetuximab biosimilar drug)

The phase III head-to-head study of A140 versus the original research cetuximab has completed pre-launch preparations in 2020, and completed the launch of the first research center and the first case enrollment (February 2021)
.
As of July 31, 54 centers have been activated, and they are making every effort to join the group
.
It is planned to complete 25% enrollment in Q3, and 50% enrollment in Q1 from Q4 to 2022 in 2021
.

6.
A277 peripheral κ opioid receptor agonist (small molecule analgesic)

① 88 cases of healthy people in stage I have been enrolled.
The safety of 0.
25-20ug/kg is good, and the main PK parameters are not significantly different from CR845, which releases clinical drug risk;

②Complete the proof-of-concept study of 45 cases in the 0.
5ug/kg group for postoperative analgesia in phase II.
The unblinded data showed that it was safe and well tolerated, reached the primary and secondary efficacy endpoints, and initially demonstrated the efficacy; completed the phase II large randomized dose exploratory study Finalized plan;

③Uremia pruritus was approved for clinical trial in 6 months.
A total of 12 patients in the 0.
25 and 0.
5ug/kg groups were enrolled in the Ib phase study, which was safe and well tolerated
.

7.
A223JAK inhibitor (rheumatoid arthritis)

①Phase I study of healthy people has been completed.
Clinical data shows that A223 is safe in healthy people, and it shows human PK characteristics different from those of the same target drug
.

②In the Phase I study of patients with rheumatoid disease, 83% of the enrollment will be completed on July 30, 2021.
The preliminary results show that there is obvious Me-better potential in terms of efficacy and safety
.
The DDI and Phase II study of combined methotrexate are in preparation for clinical research
.

8.
A204 nucleocapsid inhibitor (hepatitis B)

The single-dose dose escalation study of KL060332 capsule Ia healthy people, the fasting multiple-dose study, and the food effect study have been completed
.
The results showed that its safety was good, and there were no AEs ≥3 and serious adverse events during the study
.
Compared with similar drugs, KL060332 has a longer half-life and higher exposure at the same dose, which supports QD administration
.
The supplementary application for KL060332 tablets was completed as planned, and the clinical trial notification issued by NMPA was obtained in April 2021
.
In June 2021, the PK bridging study of KL060332 tablets and capsules in phase Ia healthy people was completed, and the ethical approval of the leader unit of the clinical trial of phase Ib hepatitis B patients was obtained
.

9.
A289 injection

A289 injection received the clinical trial notification issued by NMPA on August 3, 2020, completed the center project on March 12, 2021, and obtained the center’s ethical approval on April 25, 2021, and on June 22, 2021 Start the clinic
.

10.
A337 injection

Obtained the clinical trial notice on February 8, 2021, completed the finalization of the clinical protocol V2.
0 in April; completed the start of the team leader unit and started the subject screening in May
.

11.
KL590586 capsule (RET inhibitor)

KL590586 is a selective small-molecule pan-tumor-targeted RET kinase inhibitor, which shows clear therapeutic potential for tumors with RET oncogene mutations/fusions
.
The project has been notified of clinical trials and is in the process of pre-launch work
.

12.
A336 injection

A336 is a long-acting macromolecular anticoagulation project.
It can achieve anticoagulation treatment while reducing the risk of bleeding, and bring safer anticoagulation treatment options for clinical patients
.
The project has obtained a clinical trial notification, and preparations for the start of clinical research are in progress
.