YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 395 drug applications between 4 May 2023 and 10 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.
2023/05/04 – 2023/05/10
- New acceptances this week
- 395
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
395filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| New drug | 84 |
| Generic | 68 |
| Import | 22 |
| Import re-registration | 12 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| TCM | 63 |
| Therapeutic biologic | 62 |
| 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
52 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 | Indobufen Tablets | 2 | 2 | 6 |
| 4 | Levofloxacin Eye Drops | 2 | 2 | 16 |
| 5 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 6 | Minoxidil Liniment | 2 | 2 | 52 |
| 7 | Crisaborole Ointment | 2 | 1 | 26 |
| 8 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 9 | Nimodipine Oral Solution | 2 | 1 | 4 |
| 10 | Fluorouracil Injection | 2 | 1 | 6 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 28 | 23 | 0 |
| 2 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 19 | 17 | 0 |
| 3 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 4 | Eli Lilly and Company | 9 | 2 | 0 |
| 5 | Novo Nordisk A/S | 8 | 2 | 0 |
| 6 | Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Bard Pharmaceuticals Limited | 6 | 2 | 0 |
| 8 | Qilu Pharmaceutical (Hainan) Co., Ltd | 6 | 2 | 4 |
| 9 | AbbVie Limited | 6 | 1 | 0 |
| 10 | Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized | 5 | 2 | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/10Import · Class 1 | Eplontersen注射液 · No verified English nameJXHL2300111 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/05/10Import · Class 1 | 注射用Redasemtide · No verified English nameJXHL2300110 | Shionogi & Co. Ltd.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300109 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300108 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300107 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300106 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300105 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300104 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Generic · Class 3 | Dequalinium Chloride Buccal TabletsCYHS2301269 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Minoxidil Topical SolutionCYHS2301266 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301262 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301261 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Levofloxacin Oral SolutionCYHS2301258 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Potassium Chloride GranulesCYHS2301257 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Indobufen TabletsCYHS2301256 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/05/10New drug · Class 2.1 | 银黄吸入溶液 · No verified English nameCXZL2300033 | Zhejiang Wei Kang Pharma Co., Ltd. romanized; Ying Ke Rui (Heng Qin) Drug Research Institute Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | 注射用9MW2921 · No verified English nameCXSL2300327 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | 注射用7MW3711 · No verified English nameCXSL2300326 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300324 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | 重组NV-A01腺病毒注射液 · No verified English nameCXSL2300323 | Nanjing Nuo Wei Bio Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | CKBA软膏 · No verified English nameCXHL2300503 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | CKBA软膏 · No verified English nameCXHL2300502 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | CKBA软膏 · No verified English nameCXHL2300501 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | CKBA软膏 · No verified English nameCXHL2300500 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | CKBA软膏 · No verified English nameCXHL2300499 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10New drug · Class 2.2 | GRCE2101 · No verified English nameCXHL2300498 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/05/10New drug · Class 1 | ZB-001干混悬剂 · No verified English nameCXHL2300497 | Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2023/05/10New drug · Class 1 | 注射用HRS-7053 · No verified English nameCXHL2300496 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
101 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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