YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 24 June 2023 and 30 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 66 drug names.
2023/06/24 – 2023/06/30
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- 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
370filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 86 |
| New drug | 58 |
| Import | 25 |
| Import re-registration | 18 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 255 |
| TCM | 69 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 3 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Perampanel Tablets | 4 | 2 | 2 |
| 2 | Lactulose Oral Solution | 3 | 2 | 34 |
| 3 | Levofloxacin Eye Drops | 3 | 2 | 16 |
| 4 | Aripiprazole Tablets | 3 | 2 | 2 |
| 5 | 复方聚乙二醇(3350)电解质散 · No verified English name | 2 | 2 | 3 |
| 6 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 7 | Tadalafil Tablets | 2 | 1 | 23 |
| 8 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 9 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 10 | Pregabalin Orally Disintegrating Tablets | 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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized | 23 | 20 | 0 |
| 2 | Run Yuan Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 8 | 2 | 0 |
| 4 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Hainan Brilliant Pharmaceutical Co., Ltd. | 6 | 2 | 2 |
| 6 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shandong Da Yin Jin Kong Er Tong Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Guangxi Jin Kang Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | Novo Nordisk A/S | 5 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/30Import · Class 1 | BI 907828片 · No verified English nameJXHL2300153 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Import · Class 1 | BI 907828片 · No verified English nameJXHL2300152 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Import · Class 1 | BI 907828片 · No verified English nameJXHL2300151 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/06/30Generic · Class 3 | Epalrestat TabletsCYHS2301765 | Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2023/06/30Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2301763 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Hainan Sai Li Ke Pharma Co., Ltd. romanized |
| 2023/06/30Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2301762 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/06/30Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2301761 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/06/30Generic · Class 3 | Pentoxifylline InjectionCYHS2301750 | Henan Lang Guan Medicines Formulations Research Institute Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2023/06/30New drug · Class 1.2 | 射干止咳胶囊 · No verified English nameCXZL2300046 | Liaoning Sheng Zhong Pharmaceuticals Research Institute (Liaoning Zhong Pharmaceuticals University Fu Shu Di Er Hospital) romanized |
| 2023/06/30New drug · Class 1.2 | 射干提取物 · No verified English nameCXZL2300045 | Liaoning Sheng Zhong Pharmaceuticals Research Institute (Liaoning Zhong Pharmaceuticals University Fu Shu Di Er Hospital) romanized |
| 2023/06/30New drug · Class 1 | 注射用SBP101 · No verified English nameCXSL2300448 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2023/06/30New drug · Class 1 | HH-003注射液 · No verified English nameCXSL2300447 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/06/30New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300446 | Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized; Guangzhou Han Mi Dun Bio Technology Co., Ltd. romanized |
| 2023/06/30New drug · Class 1 | AM011注射液 · No verified English nameCXHL2300723 | Shanghai Ai Mu Medical Technology Co., Ltd. romanized |
| 2023/06/30New drug · Class 1 | AM011注射液 · No verified English nameCXHL2300722 | Shanghai Ai Mu Medical Technology Co., Ltd. romanized |
| 2023/06/30New drug · Class 2.2 | 盐酸表柔比星脂质体注射液 · No verified English nameCXHL2300721 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/06/30New drug · Class 2.2 | LPC-006口溶膜 · No verified English nameCXHL2300720 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/06/30New drug · Class 2.2 | LPC-006口溶膜 · No verified English nameCXHL2300719 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/06/30New drug · Class 1 | BW-00163注射液 · No verified English nameCXHL2300718 | Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/29Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2300050 | AstraZeneca AB; Name not romanized |
| 2023/06/29Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300123 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/06/29Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300122 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/06/29Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300121 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/06/29Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300120 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/06/29Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300119 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/06/29Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2300118 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/06/29Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2300117 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/06/29Import · Class 1 | MEDI5752 · No verified English nameJXSL2300116 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/06/29Import · Class 1 | 瑞普替尼胶囊 · No verified English nameJXHS2300056 | Bristol-Myers Squibb Company; Patheon Inc. |
| 2023/06/29Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301749 | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
68 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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