AstraZeneca Wang Lei: The China business spin-off is a rumor

AstraZeneca expressed its position on the news of the split of the online business in China.

Yesterday, the Financial Times said that a few months ago, as geopolitical tensions intensified, AstraZeneca had drawn up plans to spin off its China business and list it separately on the Hong Kong Stock Exchange.

In this regard, Wang Lei, global executive vice president, president of international business and China of AstraZeneca, responded to the media today that the news was a rumor and that everything in AstraZeneca's China business is currently normal.

The journey of pharmaceutical companies to the sea continues.

On June 17, Reindeer Bio announced that the CD19 monoclonal antibody IASO-782 injection was approved by the FDA for clinical use in autoimmune blood diseases - autoimmune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (wAIHA).

In the past day, what other hot spots in the domestic and foreign pharmaceutical markets are worth paying attention to? Let Aminojun take you to see it together.

/ 01 / Industry Express

1) Wang Lei, president of AstraZeneca China, responded: The China business spin-off is a rumor

On June 19, Wang Lei, president of AstraZeneca China, responded to the media that yesterday's Financial Times reported that "AstraZeneca has formulated a plan to spin off its China business and list it separately on the Hong Kong Stock Exchange" as a rumor, and AstraZeneca's China business is currently normal.

2) BeiGene appoints the Company's General Counsel as a senior executive

On June 18, BeiGene announced the appointment of Mr. Chan Lee, Senior Vice President and General Counsel, as the Company's Senior Executive Effective June 15, 2023, following approval by the Company's Board of Directors.

3) Hengrui Pharmaceutical terminated its cooperation and equity investment with Tianguangshi CD20 monoclonal antibody MIL62

On June 16, Hengrui Pharmaceutical announced that due to changes in the market environment and other factors, it reached a consensus with Tianguangshi Biologics to terminate the relevant cooperation on MIL62 products and terminate the preliminary equity investment intention, and signed a termination agreement.

/ 02 / Pharmaceutical News

1) Johnson's targeted CD38 monoclonal antibody daratumumab injection was approved for clinical trials

On June 19, according to the official website of CDE, Johnson's targeted CD38 monoclonal antibody daratumumab injection was approved for clinical trial and is intended to be used for the treatment of multiple myeloma patients.

2) Bio-Thera Biologics targeted PD-1 monoclonal antibody BAT1308 injection was approved for clinical trials

On June 19, according to the official website of CDE, Bio-Thera Biologics targeted PD-1 monoclonal antibody BAT1308 injection was approved for clinical trial, which is intended to be used in combination with platinum-containing chemotherapy with or without bevacizumab injection for the first-line treatment of PD-L1-positive (CPS≥1) persistent, recurrent or metastatic cervical cancer.

3) AstraZeneca-targeted NKG2A monoclonal antibody monalizumab injection was approved for clinical practice

On June 19, according to the official website of CDE, AstraZeneca's targeted NKG2A monoclonal antibody monalizumab injection was approved for clinical trial and is intended to be used in combination with duvalumab for the treatment of patients with locally advanced (stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed after radical platinum-containing drugs and concurrent chemoradiotherapy.

4) Huahui Anjian HH-012 injection was approved for clinical use

On June 19, according to the official website of CDE, Huahui Anjian HH-012 injection was approved for clinical trial and is intended to be used for advanced solid tumors.

5) Hengrui Pharmaceutical's targeted IL-5 monoclonal antibody SHR-1703 injection was approved for clinical practice

On June 19, according to the official website of CDE, Hengrui Pharmaceutical's targeted IL-5 monoclonal antibody SHR-1703 injection was approved for clinical use in eosinophilic granulomatosis with polyangiitis (EGPA).

6) The marketing application of ibrutinib tablets, a generic BTK inhibitor of Qilu Pharmaceutical, was accepted

On June 19, according to the official website of CDE, the marketing application of Qilu Pharmaceutical's generic BTK inhibitor ibrutinib tablets was accepted for the treatment of mantle cell lymphoma (MCL).

7) Glyceryl phenylbutyrate for oral use of Weijian Pharma was approved by NMPA

On June 19, Vigen Health announced that oral glyceryl phenylbutyrate has been approved by the NMPA for the long-term treatment of patients with urea cycle disorders (UCDs) that cannot be controlled by protein restriction and/or amino acid supplementation alone.

8) Phase II. clinical data of Tianguangshi targeting CD20 monoclonal antibody MIL62 in the treatment of membranous nephropathy were announced

On June 19, according to media reports, the phase II. clinical data of Tianguangshi targeting CD20 monoclonal antibody MIL62 in the treatment of membranous nephropathy was announced, and the overall remission rate of MIL62 monotherapy for 24 weeks reached 62.7%, which was obviously due to the control group (34.8%).

9) The latest results of Aosaicom Pharmaceutical's targeting of CLDN18.2 monoclonal antibody ASKB589 for solid tumors were announced

On June 17, Aosaicom Pharmaceutical announced the latest results of the Phase 1/2 multicenter clinical trial of AskGene's subsidiary, AskGene, targeting CLDN18.2 monoclonal antibody ASKB589 in patients with solid tumors. With ASKB589 in combination with CAPOX (a combination chemotherapy regimen including capecitabine and oxaliplatin), the cORR was 79.2% and the DCR was 95.8%.

10) Reindeer Bio-targeted CD19 monoclonal antibody IASO-782 injection was approved by FDA for clinical use

On June 17, Reindeer Bio announced that the CD19 monoclonal antibody IASO-782 injection was approved by the FDA for clinical use in autoimmune blood diseases - autoimmune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (wAIHA).

11) Tiangang Innuoantibody TGI-6 was approved by FDA for clinical trial

On June 16, Tiangang Yinuo announced that TGI-6, a tumor-associated antigen dual antibody targeting CD3 and tumor cell surfaces, has been approved by the FDA for the treatment of colorectal cancer and other tumor-related antigen-positive solid tumors.

12) Roche rispram oral solution was approved for new indications by NMPA

On June 16, Roche announced that rispram oral solution has been approved by the NMPA for the treatment of spinal muscular atrophy (SMA) patients aged 16 days and older. Previously, the patients with oral solution of rispram were patients with SMA over 2 months of age.

13) The phase II clinical trial of TROP2 ADC combined with PD-1 monoclonal antibody in cooperation between Kellenbertai and Merck was approved by EMA

On June 16, Colombert announced that the Phase II clinical trial targeting TROP2 ADC SKB264 (MK-2870) in combination with the anti-PD-1 monoclonal antibody pembrolizumab developed by the company and Merck (MSD) has been approved by EMA for use in selected patients with advanced solid tumors.

/ 03 / Overseas news

1) Pfizer vepdegestrant combined with pipercillide phase 2 phase III clinical trial initiated

On June 19, according to media reports, Pfizer's protein degrader vepdegestrant, combined with pipercitil, was launched in phase 2 phase III. clinical trials for the first-line treatment of patients with estrogen receptor ER-positive and human epidermal growth factor receptor HER-negative locally advanced or metastatic breast cancer. The clinical trial was designed to assess the efficacy and safety of combination therapies compared to standard care.

2) Amgen Biosimilar ABP206 Phase III clinical trial opened

On June 16, according to media reports, Amgen Biosimilar ABP206 Phase III clinical trial was opened, intended for melanoma. The trial was designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety and immunogenicity of ABP206 with nivolumab (O drug).

3) Bristol-Myers Squibb CAR-T cell therapy Breyanzi in the treatment of FL patients phase II clinical results announced

On June 17, Bristol-Myers Squibb announced that Breyanzi, a targeted CD19 CAR-T cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL), announced the results of a phase II clinical trial with an ORR of 97% and a CR rate of 94%.

4) Bristol-Myers Squibb CAR-T cell therapy Breyanzi in the treatment of MCL patients Phase I clinical trial results announced

On June 17, Bristol-Myers Squibb announced that Breyanzi, a targeted CD19 CAR-T cell therapy, for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), announced the results of a phase I clinical trial with an ORR of 86.5% and a CR rate of 74.3%.