Anigen·Daehwa·HLB. Strong Momentum[K-BIO Pulse]

[Kim Jiwan, Edaily Reporter] On March 17, according to KG Zeroin‘s MP Doctor (formerly Market Point), Anigen closed at KRW 11,600, up 13.73% (KRW 1,400) from the previous day. Daehwa Pharmaceutical closed at KRW 16,400, up 10.81% (KRW 1,600) from the previous day. HLB‘s stock price surged as investors anticipated the upcoming FDA decision on its liver cancer treatment. On March 17, HLB closed at KRW 75,600, up 5.00% (KRW 3,600) from March 14.

◇Anigen, cGMP Certification and KRW 60 Billion Investment

Anigen demonstrated a sharp upward trend, fueled by expectations of obtaining ‘Current Good Manufacturing Practice’ (cGMP) certification from the U.S. Food and Drug Administration (FDA).

On the same day, Pharm Edaily reported in a paid news article titled “Former FDA Investigator: ’No Issues with cGMP Certification‘ … Anigen Eyes $8 Billion U.S. Fertility Market” that a former FDA investigator affirmed Anigen’s cGMP certification process was proceeding smoothly.

Douglas Campbell, who oversaw Anigen‘s preliminary cGMP certification inspection for the U.S. Food and Drug Administration (FDA). (Provided by PDA)

Anigen officials confirmed that they had received a preliminary inspection report following the FDA’s pre-assessment. Anigen stated, “The report contained only minor comments with no major issues, leading us to remain optimistic about the final certification outcome.”

The preliminary inspection was conducted by Douglas Campbell, a consultant at the Parenteral Drug Association (PDA), who has 14 years of experience handling cGMP certification at the FDA.

Additionally, the company is set to secure a KRW 60 billion investment, further fueling its stock price surge. According to Anigen’s Chief Strategy Officer, Park Won-young, the HLB Group is currently conducting due diligence on Anigen. Once the process is completed, Anigen will receive a total investment of KRW 60 billion?KRW 20 billion from HLB Group and KRW 40 billion from financial investors (FI).

Park also noted that while CEO Kim Jae-il will continue leading the company, Anigen will undergo a formal name change and officially become an HLB Group subsidiary.

◇Daehwa Pharma, Chinese Anticancer Drug Sales Momentum

Daehwa Pharmaceutical saw a significant increase in stock price, driven by the continued momentum of Liporaxel oral anticancer drug sales in China and expectations of expanded indications.

On March 17, Daehwa Pharmaceutical closed at KRW 16,400, up 10.81% (KRW 1,600) from the previous day.

paclitaxel 30ml/300mg. (Photo=Daehwa Pharmaceutical)

Daehwa’s Chinese partners, Haihe Biopharma and local distributor 3S BIO, have commenced full-scale distribution and sales of Liporaxel. Unlike traditional injectable anticancer drugs, Liporaxel is an oral formulation, greatly improving treatment convenience for patients.

A Daehwa Pharmaceutical official stated, “We received marketing approval for gastric cancer treatment last year, and our partners have recently begun sales in China.”

Currently, Liporaxel is being sold for gastric cancer treatment, but Daehwa plans to expand its indications to recurrent and metastatic breast cancer.

Daehwa Pharmaceutical disclosed that in a Phase 2/3 clinical trial for metastatic and recurrent breast cancer, Liporaxel demonstrated efficacy and safety comparable to existing intravenous formulations. Based on these results, the company plans to proceed with the regulatory approval process for expanded indications.

◇HLB, FDA Liver Cancer Drug Approval Decision D-3

According to industry sources, the FDA’s decision on the New Drug Application (NDA) for the combination therapy of “Rivoceranib” and “Camrelizumab” (PD-1 inhibitor by Jiangsu Hengrui Medicine) as a first-line liver cancer treatment will be announced on March 20 (U.S. local time).

Previously, in May 2023, the FDA rejected HLB’s initial application due to issues related to Chemistry, Manufacturing, and Controls (CMC). The FDA issued a Complete Response Letter (CRL), requesting additional data and modifications.



Despite the initial rejection, HLB remains confident about obtaining FDA approval.

An HLB official stated, “The previous rejection was due to CMC issues, not the efficacy of Rivoceranib itself.”

HLB completed all necessary modifications and resubmitted its FDA application in September 2023.

An industry expert commented, “The fact that HLB reapplied just four months after the initial rejection strongly indicates that the drug’s efficacy was not the issue. Since the previous rejection was due to minor concerns, the upcoming decision is expected to be favorable.”

HLB also announced that its global Phase 3 trial demonstrated improved overall survival rates and surpassed both existing treatments and previous Rivoceranib combination therapy data.

In anticipation of FDA approval, HLB has begun recruiting sales and marketing personnel in the United States to establish a direct sales network.