Capítulo 1850: Chapter 1293: Special Patient’s Statent (Part 2)
After ten days of intense negotiations, the European Pharmaceutical Agency (EMA) conditionally accepted Ruixing’s data security frawork plan. The key concession was allowing real-ti synchronization of all EU patient treatnt data between the main data center in China and the mirror center in Frankfurt.
The simultaneously established “Sino-European dical Data Security Supervision Committee” will have dual veto rights—either party can suspend cross-border data flow if they believe data access may endanger patient privacy or national security.
“This is a plan that no party is satisfied with but all can accept,” evaluated Huang Jiacai at an internal eting, “The EMA has preserved its regulatory authority, we’ve secured the market, and the European giants have secured their ticket to continue negotiations.”
“What about the costs?” a director asked.
“The construction and operational costs of the Frankfurt data center, approximately 80 million euros annually, will be partly borne by Ruixing and partly by several European giants. Additionally, the Chinese expert list for the supervision committee needs to be reviewed by the European side—this ans relinquishing part of the personnel authority.”
Soone in the eting room frowned: “That’s not fair.”
“Comrcial negotiations are never about absolute fairness, only relative balance,” Huang Jiacai calmly said, “More importantly, this plan breaks down the access barrier to the European market. Once the K Therapy is approved in the EU, other countries will face much less resistance to follow suit.”
He pulled up a global regulatory map: “Currently, countries that have explicitly stated they will refer to the EMA’s decision include the United Kingdom, Switzerland, Australia, Canada, and fifteen others. If Europe approves, these countries’ approval processes can be shortened by at least six months.”
Just then, an encrypted line received a video call request from Schneider.
Upon connecting, the German’s face appeared on the screen, with the background of the Frankfurt headquarters office.
“Mr. Huang, congratulations.” Schneider’s smile was sowhat sincere, “The EMA’s position paper will be officially released this afternoon. I can say, without our full support, this outco couldn’t have been achieved so quickly.”
“I noticed so andnts in the proposal,” Huang Jiacai said, “Especially regarding the EU’s preferential procurent rights, which was not within our initial discussion scope.”
Schneider’s smile thinned: “This is political reality, the European Commission wants to ensure that, under equal conditions, European companies can have preferential cooperation rights. Of course, this is based on equal conditions.”
“This could affect the fairness principle of the inclusive frawork.”
“But it ensures the European market’s openness to K Therapy.” Schneider leaned forward, “Mr. Huang, business requires compromise. We’ve helped you break the biggest regulatory barrier, and that’s sincerity. Now, we need to see your sincerity, in the soon-to-be-announced list of European partners, with our position.”
Huang Jiacai was silent for a few seconds: “The evaluation is still ongoing, but I can promise: If your comprehensive score enters the top three, you will be among Europe’s first batch of partners.”
“Top three?” Schneider frowned, “We need a more certain commitnt, given our influence in the EMA, unmatched by other competitors.”
“Influence should be reflected in the evaluation score,” Huang Jiacai remained unmoved, “Regulatory communication ability is one of the scoring items, accounting for 15%. If you can urge more EU mber states to quickly adopt the EMA’s approval conclusions, this score will naturally be high.”
After hanging up the call, a director worriedly asked: “If they indeed push other countries for quick approval, should we fulfill our promise?”
“If their score indeed ranks in the top three, we must fulfill our promise,” Huang Jiacai said, “The core of the inclusive frawork is transparency and fairness, not charity or punishnt. What we must do is ensure the scoring standard is fair, then strictly enforce it.”
He glanced at the ti: “Inform the evaluation committee, starting tomorrow we will conduct the final round of on-site inspections for all applicant companies; I want to personally participate in the European enterprises’ section.”
As the political and comrcial gas continued in Europe, in an industrial park in the Nandu Provincial City, the first standardized production line for K Therapy was in the final stages of debugging.
This production line originally belonged to a bankrupt biopharmaceutical company that Ruixing acquired and completely renovated. According to Yang Ping’s design, it aims not for traditional mass production but for flexible customized production, allowing both production of standard vectors for common mutations and small-batch production of customized vectors for rare mutations on the sa line.
“The sterile standards in the cell culture area are up to par,” Song Zimo, wearing a protective mask, checked the incubator’s paraters, “but the recovery rate in the virus purification segnt is only 68%, below the design target of 75%.”
The engineer in charge of the production line was Chen Xiao, to whom Yang Ping had assigned this new task.
“Professor Yang, Dr. Song, we’ve researched this issue for three days,” Dr. Chen pointed to the control interface of the purification equipnt, “The problem lies in the packing material of the chromatography column. There’s variability between batches supplied by the vendor, leading to unstable purification efficiency.”
“Change the vendor,” Yang Ping simply said.
“But this is currently the best packing material on the market, and there are no alternatives.”
“Then develop it ourselves,” Yang Ping said as he walked out of the workshop, starting to draw molecular structures on the hallway’s whiteboard, “Look, the current packing’s ligand is nickel ion, relying on histidine tag adsorption, but our vector surface has special glycosylation modifications, aning this adsorption efficiency is inherently low.”
He drew a new molecular structure: “If we replace the ligand with cobalt ion, and simultaneously modify the purification tag of the vector, the adsorption specificity can increase by more than three tis.”
Dr. Chen was stunned: “This requires redesigning the gene sequence of the vector…”
“That’s why it needs to be changed,” Yang Ping said, “Our vector was designed to be the third generation, it was ant to be iterative. Identifying the problem now is an opportunity for improvent; iteration should be positive and swift.”
“But the production line is set for trial production next week, redesigning ans all validation has to start over, delaying at least three months!”
“If the products produced are unqualified, speed ans nothing,” Yang Ping’s tone remained steady, “The first principle of dical products is quality, not speed.”
Song Zimo added from the side, “Dr. Chen, the professor is right, the K Therapy is directly injected into the human body, any incomplete purification could lead to uncontrollable fatal immune reactions, we can’t take that risk.”
Dr. Chen was silent for a few minutes before finally nodding: “I understand, I will imdiately organize the team to redesign the purification process. But Professor Yang, you’ll need to provide the new vector sequence.”
“You’ll have it tonight,” Yang Ping checked his watch, “Additionally, inform the quality control team to re-evaluate all raw material suppliers. If any batch instability is detected, initiate an alternative plan imdiately.”
After hearing Yang Ping’s decision to make changes, Huang Jiacai did not question it, only asked: “A three-month delay, how does this impact global supply?”
“Currently, there are about three thousand patients waiting for treatnt,” Chen Xiao pulled up the data, “At the current production capacity, in three months we can produce about fifteen hundred doses, aning half of these three thousand patients will have to wait an additional three months.”
“Mortality rate?”
“Based on the severity of the illness, the natural mortality rate ranges from 5% to 10% per month.”
Huang Jiacai closed his eyes, his fingers pressing against his temples, facing a cruel math problem—the insistence on quality ans so patients might not survive the wait for treatnt; compromising on quality risks those receiving the treatnt facing potential dangers.
“What if we split it into two batches?” he opened his eyes, “The first batch is produced as per the original plan but only for the most critical patients, while informing them of the risks. The second batch waits until the new process is verified before production, for patients whose condition is relatively stable.”
Yang Ping shook his head, “This violates dical ethics, we can’t grade patients, we can’t tell so people their drug quality might be lower, but since you’re about to die anyway, and because unqualified resulting potential adverse reactions would undermine the confidence we’ve built so far, which is very detrintal to the promotion of K Therapy, resulting in fewer patients being cured, so either all are qualified, or none are.”
“Then delay it,” Huang Jiacai said, imdiately instructing those around him, “We need to publicly disclose the delay reason and the new schedule, accept supervision; establish an ergency pathway, allowing the most critical patients to apply for the trial batch, but it must co with full inford consent and additional safety monitoring; expedite the construction of the second production line to compensate for the capacity loss.”
Huang Jiacai couldn’t help but admire Professor Yang’s calmness and rationality, he never considers issues based on subjective feelings but provides scientific analysis. Sotis even Huang Jiacai couldn’t understand Professor Yang, whether he was compassionate or purely rational.
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