China-made new drugs actively enter the global market

Jiangsu Hengrui Pharmaceuticals·BeiGene have commercialized immunotherapy…have entered phase 3 trials for bispecific antibodies

Many companies in South Korea are still in the early stages of clinical trials, such as preclinical·Phase1…significant difference in the number of out-licensing deals

Many Chinese pharmaceutical and biotech companies are demonstrating results from their new anti-cancer drug development in the global market.

 

Companies like Jiangsu Hengrui Pharmaceuticals and BeiGene have obtained approvals for their immunotherapy and targeted anti-cancer agents from the regulatory authorities globally, including South Korea, the United States, and Europe.

 

The gap between Chinese and Korean pharmaceutical and biotech companies has increased as Chinese companies succeeded in commercialization and Phase 3 clinical trial entries.

 

It has been reported that most new anti-cancer drugs from Korean pharmaceutical and biotech companies remain in the preclinical stages or phase 1 clinical trials.

 

Two immunotherapy drugs have been commercialized in the U.S….bispecific antibodies have entered phase 3 trials

According to industry sources on January 14, the US Food and Drug Administration (FDA) recently approved 'Tevimbra,' an immunotherapy developed by a Chinese pharmaceutical company, BeiGene, as a first-line treatment for HER2-positive gastric cancer.

 

Following the approval, Tevimbra became the third immunotherapy following MSD's Keytruda and BMS·Ono Pharmaceutical's Opdivo to be used as a first-line treatment for HER2-positive gastric cancer.

 

In November 2023, Tevimbra received domestic approval as a monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or have experienced recurrence or progression following such treatment.

 

BeiGene has started over 17 clinical trials for potential indications for Tevimbra.

 

The company has already confirmed positive results from 11 phase 3 trials and 4 phase 2 trials.

 

To date, over 900,000 patients have been treated with Tevimbra.

 

Tevimbra obtained approvals from over 40 countries worldwide.

 

Chinese pharmaceutical companies had previously failed to obtain approvals from global regulatory authorities when only enrolling Chinese patients.

 

Now, these companies are overcoming the approval hurdles by enrolling patient groups of various ethnicities and genders.

 

In November 2023, 'Loqtorzi,' anti-PD-1 immunotherapy from China's Junshi Biosciences, was approved in the United States.

 

Loqtorzi has been approved as the first-line treatment in combination with platinum-based chemotherapy for the treatment of metastatic or locally advanced nasopharyngeal carcinoma (NPC).

 

Junshi Biosciences entered into an out-licensing deal with the US-based Coherus BioSciences for Loqtorzi with an upfront payment of US$ 150 million, totaling US$ 1.1 billion (approximately KRW 1.6 trillion).

 

Jiangsu Hengrui Pharmaceuticals aims to receive approval for its camrelizumab in combination with the HLB group's targeted anti-cancer, Rivoceranib.

 

In May 2024, Jiangsu Hengrui Pharmaceuticals and HLB received a Complete Response Letter (CPL) from the FDA but received a decision of 'not required to take additional actions' during the site monitoring.

 

The combination therapy containing Rivoceranib and Jiangsu Hengrui Pharmaceuticals' immunotherapy, camrelizumab, demonstrated the longest survival extension benefit as the first-line treatment for liver cancer.

 

China's Innovant is knocking on the door of the FDA in collaboration with the global pharmaceutical company Eli Lily.

 

Following obtaining approval for the immunotherapy sintilimab in China, Innovant signed an out-licensing agreement with Eli Lily in 2015 worth US$ 1 billion (approximately KRW 1.3375 trillion).

 

Both companies applied for approval of sintilimab for the treatment of non-small cell lung cancer (NSCLC) but failed to obtain the FDA approval.

 

Lily and Innovant plan to conduct multi-regional clinical trials comparing sintilimab+chemotherapy to the existing standard therapy as requested by the FDA.

 

Chinese pharmaceutical companies are showing results in bispecific antibodies.

 

Last year, the PD-1/VEGF bispecific antibody ivonescimab demonstrated superior effects than Keytruda.

 

Based on a Phase 3 clinical trial involving 398 patients with PD-L1-positive NSCLC, ivonescimab reduced the tumor progression risk by 49% than Keytruda.

 

Ivonescimab is a bispecific antibody developed by China's Akeso, and Akeso signed a partnership agreement with the US-based Summit Therapeutics.

 

Summit Therapeutics has the right to develop ivonescimab in the U.S., Canada, Europe, Japan, and Latin America.

 

Akeso is developing AK112, a new drug candidate, in China and Australia.

 

Chinese biotech company SystImmune is developing 'BL-B01D1,' targeting EGFR and HER3, which are commonly found in solid cancers.

 

The company has confirmed the efficacy and safety in clinical trials and out-licensed the candidate to BMS for US$ 8.4 billion (KRW 11.7 billion).

 

Korean companies' candidates are in the early phases of clinical trials…increasing gap between China Chinese companies have successfully commercialized their immunotherapies and bispecific antibodies.

 

However, Korean pharmaceutical and biotech industry candidate products are still in the early phases of clinical trials.

 

TiumBio is conducting a Phase 2ab trial of its immunotherapy candidate TU2218.

 

TU2218 blocks pathways of transforming growth factor beta (TGF-ß) and vascular endothelial growth factor (VEGF), which are known to hinder cancer immunotherapy activation.

 

In a Phase 1a trial, TU2218 treatment reduced the blood concentration of major biomarkers of connective tissue growth factor (CTGF), whose expression is known to be regulated by TGF-ß.

 

After seven days, CTGF blood concentration decreased by 27% on average compared to baseline levels.

 

Currently, in addition to the TU2218 monotherapy, TiumBio is also conducting clinical trials for a combination therapy that includes Keytruda.

 

GI Innovation recently modified its Phase ½ clinical trials in the United States studying immunotherapy candidate 'GI-102' to confirm its combination with Enhertu.

 

GI-102, which acts on CD80 and interleukin (IL)-2.

 

IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells.

 

GI-102 is being developed as intravenous (IV) and subcutaneous (SC) formulations.

 

GI-102 demonstrated potential in a monotherapy clinical trial.

 

According to Phase 1/2a clinical trial data presented by the company, Skin melanoma patients treated with GI-102 had an objective response rate (ORR) of 43%.

 

Under GI-102 treatment, lymphocyte proliferation was found, and there has been no significant drug toxicity regarding the safety profile.

 

ImmuneOnsia confirmed the drug safety profile of its immunotherapy candidate, IMC-002, is a dose-escalation Phase 1a trial.

 

IMC-002 works by blocking the signal between CD47 of cancer cells and macrophages.

 

The company monitored the effect of IMC-002 in 12 patients, and there was no drug toxicity in each dosage.

 

Six out of 12 patients had steady disease (SD).

 

The company plans to determine the recommended dosage for the phase 2 trial based on the results from the phase 1 trials.

 

ABL Bio has started a phase 1 trial to evaluate the efficacy and safety of its immunotherapy candidate ABL103 in patients with advanced·metastatic solid cancer.

 

The company aims to evaluate the safety and tolerability of ABL103 monotherapy and determine the recommended dosage and maximum tolerated dose for a subsequent phase 2 clinical trial.

 

The phase 1 trial will be conducted in both South Korea and the United States.

 

In preclinical studies, ABL103 demonstrated to induce 4-1BB activation in tumor microenvironments expressing B7-H4.

 

Additionally, it showed complete eradication of cancer cells and the suppression of recurrence in homologous cancer cells.

 

Pharmaceutical personnel said, "New drug candidate discovery capacity of Korean companies is at the global level.

 

However, they have difficulty entering a later phase of clinical trials.

 

To secure global approval, these companies need to conduct multi-national clinical trials and clinical trials across numerous sites.

 

Therefore, raising the funds can be difficult." "Companies must demonstrate the benefits of new drug candidates and how to address their weaknesses in clinical trials.

 

They should identify unmet needs in clinical practices before conducting trials and set goals for the development of new drugs based on intended purpose," he added.