3SBio Enters into Strategic Collaboration for Semaglutide Injection (Weight Management Indication)

Another pharmaceutical company enters the weight-loss drug market.

On May 28, 3SBIOINC and Hanmi Pharmaceuticals jointly announced that they had reached a cooperation agreement on the Semaglutide Injection. According to the agreement, Hanmi Pharmaceuticals and 3SBio Group's subsidiary, 3SBio Mandi, will jointly develop, exclusively supply/purchase, and share sales revenue of the Semaglutide Injection (for weight loss indications).

3SBIOINC will pay Hanyu Pharmaceuticals up to 270 million yuan in milestone payments according to the agreement. 3SBIOINC will also pay Hanyu Pharmaceuticals an exclusive purchase price and sales royalties.

Johnson & Johnson Accelerates Dual-Antibody Strategy.

On May 28, Johnson & Johnson announced that it would acquire YellowJersey Therapeutics, a subsidiary of Numab Therapeutics, for a total of $1.25 billion in cash, thereby obtaining NM26, a novel first-in-class bispecific antibody.

Burning Rock Biotech Ltd Releases Latest Report Card.

On May 29, Burning Rock Biotech Ltd released its Q1 2024 earnings report. During the reporting period, the company achieved revenue of 125.6 million yuan and gross profit of 85.7 million yuan.

In the past day, what are the hotspots in the pharmaceutical market at home and abroad that are worth paying attention to? Let Amino take you to explore.

1. Market Express

1) Gan&Lee Pharmaceuticals Passes Pre-Approval GMP Inspection by the EU EMA

On May 29, Gan&Lee Pharmaceuticals announced that it had recently received formal notification from the EMA, stating that the company's manufacturing facilities comply with EU GMP regulations and are now qualified for the commercial production of insulin glargine injection, insulin lispro injection, insulin aspart injection, and prefilled injection pens.

2) 3SBIOINC Introduces Semaglutide

On May 28, 3SBIOINC and Hanyu Pharmaceutical jointly announced that they had reached a cooperation agreement on the semaglutide injection. According to the agreement, Hanyu Pharmaceutical and SanSheng WanDi, a subsidiary of 3SBIOINC, will jointly develop, exclusively supply/purchase, and share sales revenue of the semaglutide injection (for weight loss indication). SanSheng WanDi will pay up to 270 million yuan in milestone payments to Hanyu Pharmaceutical according to the agreement. SanSheng WanDi will also pay an exclusive purchase price and sales royalties to Hanyu Pharmaceutical.

2. Capital Information

1) Some Directors and Senior Executives of BGI Plan to Increase Their Shareholdings in the Company

On May 29, BGI Genomics Co., Ltd. announced that some of the company's directors and senior management plan to increase their holdings of the company's stock within six months from the date of this announcement through the Shenzhen Stock Exchange trading system in accordance with relevant laws and regulations (including centralized bidding and block trading methods). The total amount of the increase will be no less than RMB 10 million.

2) Burning Rock Biotech Ltd's Q1 Revenue Reaches 125.6 Million Yuan

On May 29, Burning Rock Biotech Ltd released its Q1 2024 earnings report. During the reporting period, the company achieved revenue of 125.6 million yuan and gross profit of 85.7 million yuan.

3. Drug and Device Updates

1) Merck's MK-7240 Injection Approved for Clinical Use

On May 28, according to the CDE official website, Merck's MK-7240 injection has been approved for clinical trials, aiming to conduct research on treating moderate to severe active Crohn's disease.

2) A subsidiary product of Wanbangde receives FDA orphan drug designation in the U.S.

On May 28, Wanbangde New Buliding Materials Co., Ltd. announced that its subsidiary, Wanbangde Pharmaceutical, received a designation letter from the FDA, granting orphan drug status to Huperzine A for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE).

3) KN046, developed by Alphamab Oncology, in combination with chemotherapy as a first-line treatment for pancreatic cancer, did not meet the primary endpoint of OS in a Phase III study.

On the evening of May 28, Alphamab Oncology announced that the Phase III KN046-303 study of PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine for the treatment of unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma in patients who have not received systemic treatment did not meet the pre-specified statistical endpoint for overall survival (OS).

4) Ribo Biotech's siRNA Drug Approved for Clinical Trials by EMA

On May 29, RiboBio announced that its self-developed anti-thrombotic siRNA drug RBD4059 targeting FXI has recently received Phase II clinical trial approval from the European Medicines Agency (EMA).

4. Overseas Pharmaceutical News

1) Six sites with Penicillium were found in Kobayashi Pharmaceutical's Osaka plant.

On May 29, according to the MB5 News Japan report on the same day, the inspection results of Kobayashi Pharmaceutical's Osaka factory were announced in the afternoon. At Kobayashi Pharmaceutical’s Osaka factory, six locations were found to have Penicillium mold, which was identified as the same type of Penicillium that produces Penicillic acid found at its Wakayama factory.

2) K drug neoadjuvant treatment for triple-negative breast cancer reaches OS endpoint

On May 28, Merck announced positive results from the Phase 3 clinical trial KEYNOTE-522. The data showed that Keytruda in combination with chemotherapy as a preoperative neoadjuvant therapy and as a postoperative monotherapy adjuvant treatment achieved the overall survival (OS) endpoint for patients with high-risk early-stage triple-negative breast cancer (TNBC). Compared with chemotherapy as a neoadjuvant therapy, Keytruda is the first immunotherapy regimen as a neoadjuvant combination therapy and monotherapy adjuvant treatment to demonstrate a statistically significant improvement in OS for this patient population.

3) Merus Announces Positive Data from Bispecific Antibody Petosemtamab Combination Therapy

On May 28, Merus announced positive data from the Phase 1/2 clinical trial of the bispecific antibody petosemtamab in combination with pembrolizumab as a first-line therapy for patients with head and neck cancer. The results showed that the overall response rate for patients receiving the petosemtamab combination therapy was 67%, regardless of the patient's tumor PD-L1 expression level or human papillomavirus (HPV) status.

4) Johnson & Johnson Acquires Bispecific Antibody Biotech for $1.25 Billion

On May 28, Johnson & Johnson announced that it would acquire YellowJersey Therapeutics, a subsidiary of Numab Therapeutics, for a total cash amount of $1.25 billion, thereby obtaining NM26, a novel first-in-class bispecific antibody.

Editor: Bai Ji

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