YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 182 drug applications between 1 May 2023 and 7 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 31 drug names.
2023/05/01 – 2023/05/07
- New acceptances this week
- 182
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- Accepted this week, now under review
- 0
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
182filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 84 |
| New drug | 41 |
| Generic | 37 |
| Import | 11 |
| Import re-registration | 7 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 112 |
| Therapeutic biologic | 40 |
| TCM | 29 |
| Prophylactic biologic | 1 |
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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Arginine and Ibuprofen Granules | 3 | 1 | 11 |
| 2 | Fluorouracil Injection | 2 | 1 | 6 |
| 3 | Nicorandil for Injection | 2 | 1 | 1 |
| 4 | 硝酸甘油葡萄糖注射液 · No verified English name | 2 | 1 | 0 |
| 5 | Amikacin Sulfate injection | 2 | 1 | 4 |
| 6 | Tadalafil Tablets | 1 | 1 | 23 |
| 7 | Voriconazole for Oral Suspension | 1 | 1 | 1 |
| 8 | Epalrestat Tablets | 1 | 1 | 1 |
| 9 | Indobufen Tablets | 1 | 1 | 6 |
| 10 | 吸入用布地奈德混悬液 · No verified English name | 1 | 1 | 7 |
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
108 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 9 | 8 | 0 |
| 2 | Novo Nordisk A/S | 8 | 2 | 0 |
| 3 | Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | McNeil Sweden AB | 4 | 1 | 0 |
| 6 | Ha Yao Group Pharmaceutical Factory romanized | 4 | 1 | 0 |
| 7 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Heilongjiang Jia Yue Ze Medical Technology Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Ren He Yi Kang Group Co., Ltd. romanized | 3 | 2 | 3 |
| 10 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | 3 | 2 | 1 |
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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液 · No verified English nameJXSS2300036 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液 · No verified English nameJXSS2300035 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液 · No verified English nameJXSS2300034 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | VAY736注射液 · No verified English nameJXSL2300091 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/05/07Import · Class 2.2 | (decitabine and cedazuridine)片 · No verified English nameJXHL2300103 | Otsuka Pharmaceutical Co. Ltd; Otsuka Beijing Research Institute |
| 2023/05/07Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2301237 | Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2023/05/07Generic · Class 3 | Fluorouracil InjectionCYHS2301235 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/05/07Generic · Class 3 | Fluorouracil InjectionCYHS2301234 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/05/07Generic · Class 3 | Minoxidil LinimentCYHS2301232 | Name not romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/07Generic · Class 3 | Esketamine Hydrochloride InjectionCYHL2300070 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/05/07New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2300029 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/05/07New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2300028 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/05/07New drug · Class 3.3 | 注射用BLB101 · No verified English nameCXSL2300317 | Beijing Li Bang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/07New drug · Class 3.3 | GLR1023注射液 · No verified English nameCXSL2300316 | Gan Li Pharma Co., Ltd. romanized |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHL2300473 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHL2300472 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHL2300471 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHL2300470 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/05/07New drug · Class 2.2 | 盐酸达泊西汀口溶膜 · No verified English nameCXHL2300469 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/05/06Import · Class 1 | Mim8 · No verified English nameJXSL2300090 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8 · No verified English nameJXSL2300089 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8 · No verified English nameJXSL2300088 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8 · No verified English nameJXSL2300087 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8 · No verified English nameJXSL2300086 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301228 | Anhui Huan Qiu Pharma Co., Ltd. romanized |
| 2023/05/06Generic · Class 3 | 硝酸甘油葡萄糖注射液 · No verified English nameCYHS2301227 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/05/06Generic · Class 3 | 硝酸甘油葡萄糖注射液 · No verified English nameCYHS2301226 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/05/06Generic · Class 3 | Nicorandil for InjectionCYHS2301224 | Guangdong Hai He Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/06Generic · Class 3 | Nicorandil for InjectionCYHS2301223 | Guangdong Hai He Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/06Generic · Class 3 | Epalrestat TabletsCYHS2301215 | Hui Sheng Biopharmaceutical Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
38 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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