YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 15 October 2024 and 21 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 77 drug names.
2024/10/15 – 2024/10/21
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 3
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
360filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 139 |
| Generic | 100 |
| New drug | 81 |
| Import | 25 |
| Unspecified | 10 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 64 |
| Therapeutic biologic | 56 |
| Biologic | 7 |
| Prophylactic biologic | 7 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bromhexine Hydrochloride Injection | 3 | 3 | 8 |
| 2 | Hydrocortisone Sodium Succinate for Injection | 3 | 2 | 16 |
| 3 | 匹伐他汀钙口崩片 · No verified English name | 3 | 1 | 0 |
| 4 | Fudosteine oral solution | 3 | 1 | 7 |
| 5 | Potassium Chloride Oral Solution | 2 | 2 | 11 |
| 6 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 7 | 聚乙二醇3350散 · No verified English name | 2 | 2 | 2 |
| 8 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 9 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 10 | 复方聚乙二醇(3350)电解质散 · No verified English name | 2 | 1 | 3 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 2 | 0 |
| 2 | Eli Lilly and Company | 7 | 2 | 0 |
| 3 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 7 | 1 | 0 |
| 4 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Name not romanized | 4 | 3 | 0 |
| 8 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/21New drug · Class 1 | 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2400714 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2024/10/21New drug · Class 1 | SYH2059片 · No verified English nameCXHL2401117 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/21New drug · Class 1 | SYH2059片 · No verified English nameCXHL2401116 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/10/20Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2403542 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2400713 | Name not romanized; Name not romanized |
| 2024/10/19New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2401115 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2401114 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | ART101注射液 · No verified English nameCXHL2401113 | Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | AK-1286片 · No verified English nameCXHL2401112 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | AK-1286片 · No verified English nameCXHL2401111 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | LKR202注射液 · No verified English nameCXHL2401110 | Shanghai Li Kang Rui Bio Gong Cheng Co., Ltd. romanized; Shanghai Hao Hai Bio Technology Co., Ltd. romanized |
| 2024/10/19New drug · Class 1 | 盐酸吉卡昔替尼片 · No verified English nameCXHL2401109 | Name not romanized; Name not romanized |
| 2024/10/18Import · Class 3.1 | Tremelimumab注射液 · No verified English nameJXSS2400099 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/10/18Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2400098 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/18Import · Class 3.1 | Tremelimumab注射液 · No verified English nameJXSS2400097 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/10/18Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2400096 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2024/10/18Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400197 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/10/18Import · Class 1 | Belrestotug注射液 · No verified English nameJXSL2400196 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400254 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400253 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400252 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400251 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400250 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2400249 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/10/18Generic · Class 3 | Medium and Long Chain Fat Emulsion,Amino Acids(16)and Glucose(36%) InjectionCYHS2403541 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/10/18Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2403540 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/10/18Generic · Class 3 | 碳酸氢钠林格注射液(Ⅰ) · No verified English nameCYHS2403539 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/10/18Generic · Class 3 | 匹伐他汀钙口崩片 · No verified English nameCYHS2403538 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/10/18Generic · Class 3 | 匹伐他汀钙口崩片 · No verified English nameCYHS2403537 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/10/18Generic · Class 3 | 匹伐他汀钙口崩片 · No verified English nameCYHS2403536 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
115 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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