YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 372 drug applications between 5 May 2024 and 11 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 81 drug names.
2024/05/05 – 2024/05/11
- New acceptances this week
- 372
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- 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
372filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 109 |
| New drug | 67 |
| Import | 24 |
| Import re-registration | 12 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 256 |
| TCM | 57 |
| Therapeutic biologic | 57 |
| 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
81 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 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 5 | Deutetrabenazine Tablets | 3 | 1 | 0 |
| 6 | Nicorandil for Injection | 3 | 1 | 1 |
| 7 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 10 | Perampanel Tablets | 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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 16 | 15 | 0 |
| 2 | Hubei Di Liu Pharmaceutical Co., Ltd. romanized | 7 | 5 | 0 |
| 3 | Janssen Research & Development LLC | 7 | 3 | 0 |
| 4 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 7 | 2 | 2 |
| 5 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 6 | 2 | 3 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2400091 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2400090 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2400089 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/05/11Import · Class 2.2; 2.4 | 盐酸氨酮戊酸己酯软膏光动力治疗系统 · No verified English nameJXHS2400035 | ASIERIS MEDITECH (Hong Kong) CO. LIMITED; Bioglan AB; Jiangsu Yahong Meditech Co. Ltd. |
| 2024/05/11Import · Class 1 | BI 690517片 · No verified English nameJXHL2400106 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/05/11Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2401422 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2401421 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2401419 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2401416 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Nicorandil for InjectionCYHS2401411 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Nicorandil for InjectionCYHS2401410 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | Nicorandil for InjectionCYHS2401409 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2401405 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/05/11Generic · Class 3 | Enalapril Maleate Oral SolutionCYHS2401404 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2024/05/11Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400089 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2400307 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/05/11New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2400306 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | RC148注射液 · No verified English nameCXSL2400305 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | 迈华替尼片 · No verified English nameCXHS2400041 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | 迈华替尼片 · No verified English nameCXHS2400040 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | AL2846胶囊 · No verified English nameCXHL2400463 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/05/11New drug · Class 2.4 | Chidamide TabletsCXHL2400462 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | 注射用DN022150 · No verified English nameCXHL2400461 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2024/05/11New drug · Class 2.2 | B0123 · No verified English nameCXHL2400460 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | TJ0113胶囊 · No verified English nameCXHL2400459 | Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | TJ0113胶囊 · No verified English nameCXHL2400458 | Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized |
| 2024/05/11New drug · Class 1 | 注射用PLAT001 · No verified English nameCXHL2400457 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 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. |
99 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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