The world's first PD-1 and ADC combination therapy was approved; Combe first quarter net profit pre-increase 150% to 200%

PD-1 and ADC have joined forces.

On April 3, Merck and Seagen announced accelerated FDA approval of Keytruda and Padcev for first-line treatment of locally relapsed or metastatic uroepithelial carcinoma.

A quarter results pre - opening period.

April 4, Kangbei announcement, expected 2023 first quarter net profit of 254 million yuan - 305 million yuan, year-on-year growth of 150%-200%.

In the past day, what other hot spots in the domestic and foreign pharmaceutical market are worth paying attention to? Let me show you around.

01

Market express

1) Combe's net profit in the first quarter increased 150% to 200%

April 4, Kangbei announcement, expected 2023 first quarter net profit of 254 million yuan - 305 million yuan, year-on-year growth of 150%-200%.

2) Zorui Robot completed a C3 round of financing worth hundreds of millions of yuan

On April 4, the company announced that it had successfully completed a C3 round of financing worth hundreds of millions of yuan. This round of financing will help Zhurui Robot to continue to promote the clinical trials and marketing of existing products in multiple departments at home and abroad, as well as the research and development of new generation products.

02

Pharmaceutical trends

1) Ying Shi Bio IN10018 tablets was approved for clinical use

On April 4, according to the website of CDE, Bio IN10018 tablets was approved for clinical study in combination with taxanes and anti-PD-1 /PD-L1 monoclonal antibody for the treatment of locally advanced or metastatic solid tumors that have failed or been intolerant to at least first-line standard therapy.

2) FZ-AD004 antibody coupling agent for injection by Fudan Zhangjiang was approved for clinical use

On April 4, according to the official website of CDE, Fudan Zhangjiang injection of FZ-AD004 antibody coupling agent approved clinical, intended to carry out the treatment of advanced solid tumor research.

3) Qilu Pharmaceutical injection QLP2117 was approved for clinical use

On April 4, Qilu Pharmaceutical injection QLP2117 was approved for clinical study in the treatment of advanced solid tumors, according to the CDE website.

4) HSK38008 dry suspension was approved for clinical use

On April 4, HSK38008 dry suspension was approved for the treatment of metastatic castration-resistant prostate cancer, according to the CDE website.

5) Alysvometinib tablet was approved for clinical use

On April 4, according to the CDE website, Alysvometinib tablet was approved for the treatment of adult patients with non-small cell lung cancer who carry mutations in epidermal growth factor receptor or human epidermal growth factor receptor 2 kinase domain activation.

6) Yiling Pharmaceutical G201-Na capsule was approved for clinical use

On April 4, according to the official website of CDE, Yiling Pharmaceutical G201-Na capsule was approved for clinical use, intended to carry out research on the treatment of prostate cancer requiring androgen castration.

7) Kangdai Biologic KD6001 injection was approved for clinical use

On April 4, according to the official website of CDE, Kangdai Biologic KD6001 injection was approved for clinical use. It is planned to carry out a study of combining Tirelizumab with bevacizumab in the treatment of patients with advanced liver cancer and other solid tumors.

8) SHR-4602 for injection of Hengrui Medicine was approved for clinical use

On April 4, according to the website of CDE, Hengrui Pharmaceutical injectable SR-4602 was approved to treat solid tumors with HER2 expression or mutation.

9) Jiudian Pharmaceutical Flubiprofen patch was approved for clinical use

On April 4, according to the website of CDE, Jiudian Pharmaceutical flubiprofen patch was approved for clinical use in pain relief and anti-inflammatory research.

10) Zhengda Tianqing TQB3616 capsule was approved for clinical use

On April 4, according to the official website of CDE, Zhengda Tianqing TQB3616 capsules was approved for clinical study, to carry out combined with fluviquetgroup, for previously untreated hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer patients.

11) Docetaxel for injection (albumin-binding type) was approved for clinical use by Shiyao Group

On April 4, according to the official website of CDE, docetaxel for injection (albumin-binding type) was approved by Shiyao Group for clinical study of simultaneous radiotherapy combined with cisplatin in the treatment of locally advanced unresectable esophageal squamous cell carcinoma.

12) Beihai Biobiology BH009 injection was approved for clinical use

On April 4, according to the website of CDE, Beihaibiol BH009 injection was approved for clinical study in the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.

13) Gax JAB-BX300 injection was approved for clinical use

On April 4, according to the official website of CDE, Gaxis JAB-BX300 injection was approved for clinical study in the treatment of advanced solid tumors.

14) Bioteconituzumab injection was approved for clinical use

On April 4, according to the official website of CDE, Biteconituzumab injection was approved for clinical study, which intends to carry out the study of combined chemoradiotherapy and sequential nituzumab maintenance in the treatment of locally advanced cervical cancer.

15) Hesco HSK37251 tablets were approved for clinical use

On April 4, according to the official website of CDE, Hesco HSK37251 tablets was approved for clinical study, intended to start the treatment of solid tumors.

16) Kangyuan Pharmaceutical KY0135 tablets was approved for clinical use

On April 4, according to the official website of CDE, Kangyuan Pharmaceutical KY0135 tablets was approved for clinical study, intended to carry out the treatment of advanced solid tumors.

17) Yiling Pharmaceutical G201-Na capsule was approved for clinical use

On April 4, according to the CDE website, Yiling Pharmaceutical G201-Na capsule was approved for clinical use in prostate cancer requiring androgen castration treatment.

18) Bozhiyan new BCM347 oral lysis membrane approved for clinical

On April 4, according to the official website of CDE, Bozhiyanxin BCM347 oral dissolving membrane was approved for clinical treatment, intended to carry out research on the treatment of phlegm viscosity and difficulty in expectoration.

19) Bozhiyanxin BCM343 sustained release tablets was approved for clinical use

On April 4, according to the website of CDE, Bozhiyanxin BCM343 sustained release tablets was approved for clinical use in adult patients with chronic heart failure (NYHAⅡ-Ⅳ, LVEF≤40%) with reduced ejection fraction to reduce the risk of cardiovascular death and heart failure hospitalization.

20) Bozhiyan new BCM345 mouth soluble membrane approved clinical

On April 4, according to the official website of CDE, Bozhiyan new BCM345 mouth solubilize was approved for clinical study, intended to carry out research on the treatment of schizophrenia.

21) Kexingzhongwei ACYW135 group meningococcal polysaccharide conjugate vaccine was approved for clinical use

On April 4, according to the official website of CDE, Kexingzhongwei ACYW135 meningococcal polysaccharide conjugate vaccine was approved for clinical use in the prevention and treatment of epidemic cerebrospinal meningitis caused by Neisseria meningitisae in groups A, C, Y and W135.

22) Optics Valley Zhongyuan VUM02 injection was approved for clinical use

On April 4, according to the website of CDE, Optics Valley Zhongyuan VUM02 injection was approved for clinical study in the treatment of idiopathic pulmonary fibrosis.

03

Instrument tracking

1) Yahuilong Automatic Biochemical Analyzer has obtained medical device registration certificate

On April 4, Yahuilong announcement, recently, the company's wholly-owned subsidiary Hunan Yahuilong Biotechnology Co., Ltd. received the medical device registration certificate issued by the Hunan Food and Drug Administration, the product name is called automatic biochemical analyzer.

2) The software for calculating coronary CT blood reserve fraction of Bobo Medical has obtained the registration certificate of medical devices

On April 4, according to the official website of NMPA, Bobo Medical coronary CT blood reserve fraction calculation software obtained the medical device registration certificate.

04

Overseas medicine

1) Accelerated FDA approval for Keytruda/Nectin-4ADC combination therapy

On April 3, Merck and Seagen announced accelerated FDA approval of Keytruda and Padcev for first-line treatment of locally relapsed or metastatic uroepithelial carcinoma.