Six Drugs Receive IND Approvals and Two New Indications Granted for Companies Including CSPC, Henlius, and AbbVie

According to company announcements and the CDE official website, six drugs have been approved for clinical trials, and two new indications have been approved! These include a PD-L1/TIGIT bispecific antibody, CTA101 UCAR-T cell injection, JAK inhibitors, and more, from companies such as Zhengda Tianqing, Henlius, and AbbVie.

Six Drugs Approved for Clinical Trials

China Resources Tianqing's TQB3820 Tablets Approved for Clinical Trials

CDE Official Website Announcement: TQB3820 Tablets from Zhengda Tianqing Receive Clinical Trial Implied Permission. The applied indications are as a single agent or in combination with dexamethasone, and in combination with proteasome inhibitors and dexamethasone for the treatment of multiple myeloma, lymphoma, and other malignant hematological tumors.

Henlius' PD-L1/TIGIT Bispecific Antibody HLX301 Approved for Clinical Trials in China

The CDE official website shows that the recombinant human anti-PD-L1/TIGIT bispecific antibody HLX301 submitted by Fosun Henlius has received clinical tacit approval, with the proposed indication being locally advanced/metastatic solid tumors or lymphoma.

Previously, on February 15, HLX301 initiated Phase I clinical research in Australia. Currently, in China, other bispecific antibodies targeting PD-(L)1/TIGIT under research include IBI321 co-developed by Innovent Biologics and Eli Lilly, PM1022 from Prime Medicine, ZG005 from Zelgen Biopharmaceuticals, and HB0036 from Huahai Pharmaceutical, all of which have entered the clinical research stage.

As of the announcement date, there are no anti-PD-1/TIGIT bispecific antibodies on the market worldwide. In addition, Merck is developing a fixed-dose combination product, MK-7684A, which includes an anti-TIGIT antibody and an anti-PD-1/PD-L1 antibody.

Adagene Announces FDA Approval for Clinical Trial of ADG126 in Combination with Pembrolizumab in the U.S.

Adagene Announces FDA Approval for Phase Ib/II Clinical Trial of ADG126, an Anti-CTLA-4 Monoclonal Antibody, in Combination with Anti-PD-1 Antibody Pembrolizumab. The Global Trial (ADG126-P001 / KEYNOTE-C98) Will Evaluate the Treatment in Patients with Advanced/Metastatic Solid Tumors at Multiple Clinical Centers in the United States and the Asia-Pacific Region (APAC).

ADG126 Safe Antibody achieves specific activation in the tumor microenvironment, enhances therapeutic efficacy by strongly depleting regulatory T cells, and maintains physiological functions through flexible ligand blocking. The unique mechanism of the safe antibody is expected to improve the therapeutic index (TI) and further overcome the safety issues commonly associated with existing CTLA-4 therapies.

BETAH Bio CT-A101 U CAR-T Cell Injection Approved for Clinical Use

The CDE official website shows that the CTA101 UCAR-T cell injection product independently developed by Beiheng Biotech has officially received clinical trial implied permission from the NMPA. CTA101 is the first "off-the-shelf" UCAR-T cell therapy product approved by the CDE in China, intended for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia.

AstraZeneca's Monalizumab Injection and Oleclumab Injection Approved for Clinical Use

CDE's official website shows that AstraZeneca's Monalizumab for injection and Oleclumab Injection have been approved for clinical use. The indications for both drugs are for the combination therapy with durvalumab to treat patients with locally advanced (Stage III), unresectable non-small cell lung cancer who have not progressed after radical platinum-based chemoradiotherapy.

Benz Pharmaceutical's Inhalation Solution of Bromhexine Hydrochloride Approved for Clinical Use

CDE's official website shows that Wanbangde Pharmaceutical's inhalation solution of bromhexine hydrochloride has been approved for clinical use. The drug is suitable for expectorant treatment in acute bronchitis, chronic bronchitis, tuberculosis, pneumoconiosis, and post-surgery.

Two New Indications Approved

FDA Approves New Indication for AbbVie's JAK Inhibitor

AbbVie announced that the U.S. FDA has approved the JAK inhibitor Rinvoq for an expanded indication, to treat adult patients with moderate to severe active ulcerative colitis.

Bayer's Rivaroxaban Approved for Pediatric Venous Thromboembolism Indication in China

Bayer announces that Xarelto (rivaroxaban tablets) has been approved in China for the treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents under 18 years old weighing between 30kg-50kg and above 50kg, following at least 5 days of initial non-oral anticoagulation therapy. Xarelto is currently the only anticoagulant in China with an indication for the treatment and prevention of VTE recurrence in pediatric patients.

Rivaroxaban entered the Chinese market in 2009 and was directly included in the national medical insurance directory that year. In August 2019, Zhengdatianqing's first generic rivaroxaban was approved for marketing. Subsequently, more than 20 companies, including CSPC Pharmaceutical Group, Yangtze River Pharmaceutical, Jiayi Pharmaceutical, Guangshengtang, and Huilun Pharmaceutical, received approval for their generic versions. In June 2021, rivaroxaban was included in China's fifth national bulk procurement program, with the highest price reduction reaching 99.42%. The original market size of 2 billion RMB for rivaroxaban shrank to just 50 million RMB (contract amount), and Bayer AG, the original developer, lost its position.

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