CEO Yang Jianxin of CStone Pharmaceuticals Accumulates 10.45 Million Shares; CAR-T Therapy for Myasthenia Gravis Advances Toward Phase III

Amino Observation - Original Production by the Innovative Drug Team

Author | Huang Kai

/ 01 /

Market Express

1) Sinopep Allsino Bio Pharmaceutical Co., Ltd. has reached a strategic cooperation with Julphar, a pharmaceutical company in the Middle East, to supply them with the active pharmaceutical ingredient semaglutide.

On April 9, Sinopep Allsino Bio Pharmaceutical Co., Ltd. announced a strategic cooperation with Julphar PSC, a well-known pharmaceutical company in the Middle East. They have reached relevant agreements with Julphar on the supply of semaglutide API in 22 countries in the Middle East and Africa, including the UAE, Qatar, Saudi Arabia, Egypt, and Morocco.

/ 02 /

Capital Information

1) CStone Pharmaceuticals' Yang Jianxin Cumulatively Increased Holdings by 10.45 Million Shares

On April 9, CStone Pharmaceuticals announced that CEO Dr. Yang Jianxin had increased his holdings by 560,000 shares from April 2 to April 7. Since August 2022, Dr. Yang Jianxin has cumulatively increased his holdings by 10.45 million shares.

/ 03 /

Pharmaceutical News

1) 3SBIOINC's SSGJ-707 Injection Granted Breakthrough Therapy Designation

On April 9, according to the CDE website, 3SBIO's SSGJ-707 injection is proposed to receive Breakthrough Therapy Designation for the indication of: first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 expression.

2) Angstone Biotech's PLB1004 Capsule Granted Breakthrough Therapy Designation

On April 9, according to the CDE website, Anshi Bio's PLB1004 capsule is proposed to receive breakthrough therapy designation for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have failed prior EGFR-TKI treatment and have EGFR mutations, MET amplification, and/or overexpression.

3) Aivi Pharmaceuticals' ophthalmic new drug granted FDA orphan drug designation

On April 8, Aiviva Pharmaceuticals announced that the U.S. FDA had granted Orphan Drug Designation to its IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile solution) for the treatment of fungal keratitis.

4) 98.1% of Patients Show Significant Improvement! RemeGen Releases Phase III Clinical Trial Data for Telitacicept in Treating Generalized Myasthenia Gravis

On April 9, RemeGen issued a press release stating that the Phase III study results of Telitacicept for the treatment of generalized myasthenia gravis (gMG) were orally presented as a "latest breakthrough study." The data showed that after 24 weeks of Telitacicept treatment, 98.1% of patients achieved an improvement of ≥3 points in the Myasthenia Gravis Activities of Daily Living score (MG-ADL), and 87% of patients achieved an improvement of ≥5 points in the Quantitative Myasthenia Gravis score (QMG), demonstrating significant clinical significance. Among the drugs that have completed Phase III clinical studies for generalized myasthenia gravis, Telitacicept has the highest MG-ADL response rate data and is expected to reshape the global treatment landscape in this disease area.

/ 04 /

Instrument Tracking

1) Wantai Bio's TB-IGRA Diagnostic Kit Included in UNOPS Procurement List

On April 9, Wantai Bio announced that its self-developed T-cell detection kit for tuberculosis infection (in vitro enzyme-linked immunosorbent assay) (TB-IGRA detection kit) has been included in the procurement list managed by the United Nations Office for Project Services (UNOPS) under the Stop TB Partnership.

2) Peijia Medical's YonFlow Flow Diverter Stent Approved for Marketing

On April 9, Peijia Medical announced that the YonFlow flow diverter stent has been approved for marketing by the pharmaceutical regulatory authority.

/ 05 /

Overseas Pharmaceutical News

1) EU Commission President Holds Talks with Pharmaceutical Industry Leaders on US Tariff Issues

On April 9, European Commission President Ursula von der Leyen spoke with pharmaceutical industry leaders and exchanged views on the U.S. tariff issue. This will help the EU formulate effective countermeasures. Reports indicate that the EU will maintain close contact with the pharmaceutical sector to ensure the interests of patients and employees are fully protected. On April 8 local time, U.S. President Donald Trump announced that the United States would impose tariffs on pharmaceuticals.

2) CAR-T Therapy for Myasthenia Gravis Shows Promise in Advancing to Phase III

Recently, Cartesian Therapeutics announced that it has communicated with the FDA and plans to initiate the first Phase III study (AURORA) of CAR-T therapy Descartes-08 for the treatment of MG in the second quarter of 2025. This means that Descartes-08 is expected to become the first CAR-T cell therapy in the autoimmune field.

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