YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 13 June 2024 and 19 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 60 drug names.
2024/06/13 – 2024/06/19
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 3
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
323filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 77 |
| New drug | 49 |
| Import | 11 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 60 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 9 |
| 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Penicillin G Sodium For Injection | 5 | 1 | 2 |
| 2 | Levocarnitine Oral Solution | 3 | 3 | 9 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 5 | Tacrolimus Capsules | 2 | 1 | 2 |
| 6 | 头孢呋辛酯干混悬剂 · No verified English name | 2 | 1 | 5 |
| 7 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 8 | Ibuprofen Suspension | 2 | 1 | 14 |
| 9 | Cariprazine hydrochloride Capsules | 2 | 1 | 3 |
| 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
185 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bracco Imaging S.P.A. | 24 | 1 | 0 |
| 2 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 3 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 8 | 7 | 2 |
| 4 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 7 | 4 | 0 |
| 5 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 7 | Novartis Pharma Schweiz AG | 5 | 3 | 0 |
| 8 | CISEN PHARMACEUTICAL CO., LTD. | 5 | 3 | 3 |
| 9 | Xizang Jin Yue Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 5 |
| 10 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 4 | 4 | 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 |
|---|---|---|
| 2024/06/19Import · Class 2.4 | 奥贝胆酸(OCA) · No verified English nameJXHL2400144 | Intercept Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2024/06/19Import · Class 2.4 | 奥贝胆酸(OCA) · No verified English nameJXHL2400143 | Intercept Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2024/06/19Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2401833 | Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2024/06/19Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2401826 | Shandong Yi He Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2024/06/19Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2401825 | Chengdu Pusch Pharmaceutical Co., Ltd. |
| 2024/06/19Generic · Class 3 | Brivaracetam TabletsCYHL2400118 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/06/19Generic · Class 3 | Brivaracetam TabletsCYHL2400117 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/06/19Generic · Class 3 | Brivaracetam TabletsCYHL2400116 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/06/19Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2400115 | Wuhan Ren Fu Pharma Co., Ltd. romanized |
| 2024/06/19Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2400114 | Wuhan Ren Fu Pharma Co., Ltd. romanized |
| 2024/06/19New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2400401 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2024/06/19New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2400400 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2024/06/19New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2400399 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
| 2024/06/19New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2400398 | Suzhou Di Xin Chen Ke Bio Technology Co., Ltd. romanized |
| 2024/06/19New drug · Class 2.2 | HCD干混悬剂 · No verified English nameCXHL2400612 | Zhejiang Sheng Bo Kang Pharma Co., Ltd. romanized |
| 2024/06/19New drug · Class 1 | HRS9950片 · No verified English nameCXHL2400611 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/06/19New drug · Class 1 | HRS9950片 · No verified English nameCXHL2400610 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/06/18Import · Class 1 | BRII-179注射液 · No verified English nameJXSL2400115 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2024/06/18Import · Class 2.2 | 注射用戈沙妥珠单抗 · No verified English nameJXSL2400114 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2024/06/18Import · Class 1 | BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2400142 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2024/06/18Generic · Class 3 | Trimebutine Maleate TabletsCYHS2401822 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2024/06/18Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401819 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/06/18Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2401815 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/06/18Generic · Class 3 | 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHS2401813 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2024/06/18Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2401812 | Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2024/06/18Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2401811 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/06/18Generic · Class 3 | Deoxycholic Acid InjectionCYHL2400113 | Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2024/06/18New drug · Class 2.3 | 白脉软膏 · No verified English nameCXZL2400034 | Xizang Qi Zheng Zang Yao Co., Ltd. romanized |
| 2024/06/18New drug · Class 3.2 | 注射用重组人促甲状腺激素 · No verified English nameCXSS2400060 | Name not romanized |
| 2024/06/18New drug · Class 1 | HRS-5635注射液 · No verified English nameCXHL2400609 | Fujian Sheng Di Pharmaceuticals 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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