YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 270 drug applications between 3 May 2023 and 9 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 40 drug names.
2023/05/03 – 2023/05/09
- New acceptances this week
- 270
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- Accepted this week, now under review
- 2
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
270filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 122 |
| New drug | 71 |
| Generic | 53 |
| Import | 11 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| Therapeutic biologic | 50 |
| TCM | 37 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dasatinib Tablets | 4 | 1 | 4 |
| 2 | Arginine and Ibuprofen Granules | 3 | 1 | 11 |
| 3 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 4 | Minoxidil Liniment | 2 | 2 | 52 |
| 5 | Crisaborole Ointment | 2 | 1 | 26 |
| 6 | Nimodipine Oral Solution | 2 | 1 | 4 |
| 7 | Fluorouracil Injection | 2 | 1 | 6 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | 硝酸甘油葡萄糖注射液 · No verified English name | 2 | 1 | 0 |
| 10 | Amikacin Sulfate injection | 2 | 1 | 4 |
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
151 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 14 | 13 | 0 |
| 2 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 3 | Novo Nordisk A/S | 8 | 2 | 0 |
| 4 | Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Xian Li Jun Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 8 | McNeil Sweden AB | 4 | 1 | 0 |
| 9 | Ha Yao Group Pharmaceutical Factory romanized | 4 | 1 | 0 |
| 10 | Jin Zhou Ao Hong Pharma 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/09Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2301255 | Hefei Hao Yi Pharmaceuticals Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2023/05/09Generic · Class 3 | Nimodipine Oral SolutionCYHS2301254 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/09Generic · Class 3 | Nimodipine Oral SolutionCYHS2301253 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/09Generic · Class 3 | Minoxidil LinimentCYHS2301247 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/05/09Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301242 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/05/09New drug · Class 3.3 | 注射用重组人促卵泡激素 · No verified English nameCXSS2300033 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2023/05/09New drug · Class 3.4 | 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300032 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2023/05/09New drug · Class 3.4 | 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300031 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2023/05/09New drug · Class 3.4 | 聚乙二醇化重组人粒细胞刺激因子注射液 · No verified English nameCXSS2300030 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | 注射用MCLA-129 · No verified English nameCXSL2300322 | Bei Da Pharma Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2300321 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | STSA-1201 皮下注射液 · No verified English nameCXSL2300320 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2300495 | Bei Da Pharma Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2300494 | Bei Da Pharma Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | QJ-19-0002片 · No verified English nameCXHL2300493 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | QJ-19-0002片 · No verified English nameCXHL2300492 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | QJ-19-0002片 · No verified English nameCXHL2300491 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | PG-018片 · No verified English nameCXHL2300489 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300488 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300487 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | PG-018片 · No verified English nameCXHL2300486 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300485 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300484 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300483 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | HZ012注射液 · No verified English nameCXHL2300482 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300481 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300480 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300479 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300478 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/09New drug · Class 1 | IPG11406片 · No verified English nameCXHL2300477 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
73 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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