YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 282 drug applications between 4 May 2024 and 10 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 64 drug names.
2024/05/04 – 2024/05/10
- New acceptances this week
- 282
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- 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
282filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 84 |
| New drug | 55 |
| Import | 16 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| Therapeutic biologic | 49 |
| TCM | 42 |
| Prophylactic biologic | 2 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Fluvoxamine Maleate Tablets | 3 | 2 | 0 |
| 3 | Telmisartan Tablets | 3 | 1 | 4 |
| 4 | Deutetrabenazine Tablets | 3 | 1 | 0 |
| 5 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
| 6 | Lactulose Oral Solution | 2 | 1 | 34 |
| 7 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 8 | Perampanel Tablets | 2 | 1 | 2 |
| 9 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 10 | 头孢地尼干混悬剂 · No verified English name | 2 | 1 | 2 |
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
181 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Di Liu Pharmaceutical Co., Ltd. romanized | 7 | 5 | 0 |
| 2 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 7 | 2 | 2 |
| 3 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 6 | 2 | 3 |
| 5 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | AstraZeneca AB | 4 | 3 | 0 |
| 8 | Takeda Pharmaceuticals International AG Ireland Branch | 4 | 2 | 0 |
| 9 | Topfond Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 10 | Shandong Lv Ye Pharmaceutical 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/10Import · Class 1 | BAY 3375968 · No verified English nameJXSL2400088 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/05/10Import · Class 1 | BI 690517片 · No verified English nameJXHL2400105 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/05/10Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2401400 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/05/10Generic · Class 3 | Indobufen TabletsCYHS2401392 | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/10Generic · Class 3 | Doxylamine Succinate TabletsCYHL2400088 | Jiangxi Xin Gan Jiang Pharma Co., Ltd. romanized |
| 2024/05/10Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400087 | Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized |
| 2024/05/10Generic · Class 3 | Doxepin Hydrochloride TabletsCYHL2400086 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/05/10Generic · Class 3 | Doxepin Hydrochloride TabletsCYHL2400085 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/05/10Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400084 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2400304 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | KAL-003 · No verified English nameCXSL2400303 | Chengdu Yan Yang Jun Bio Technology Co., Ltd. romanized; Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | KAL-003 · No verified English nameCXSL2400302 | Chengdu Yan Yang Jun Bio Technology Co., Ltd. romanized; Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | 注射用BG-C9074 · No verified English nameCXSL2400301 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | RC1416注射液 · No verified English nameCXSL2400300 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | RC1416注射液 · No verified English nameCXSL2400299 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | IBI354 · No verified English nameCXSL2400298 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400456 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400455 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400454 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | LPM787000048马来酸盐缓释片 · No verified English nameCXHL2400453 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2400452 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2400451 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400450 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400449 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400448 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400447 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400446 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400445 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400444 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/10New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400443 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
72 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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