YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 393 drug applications between 31 July 2025 and 6 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 72 drug names.
2025/07/31 – 2025/08/06
- New acceptances this week
- 393
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 91
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
393filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 99 |
| New drug | 71 |
| Import re-registration | 22 |
| Import | 14 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 98 |
| Therapeutic biologic | 59 |
| Prophylactic biologic | 2 |
| 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 3 | 70 |
| 2 | Cefditoren Pivoxil Granules | 3 | 2 | 18 |
| 3 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 4 | Finerenone Tablets | 3 | 2 | 69 |
| 5 | Levetiracetam Tablets | 3 | 1 | 6 |
| 6 | Acetylcysteine Injection | 2 | 2 | 53 |
| 7 | 头孢克肟干混悬剂 · No verified English name | 2 | 2 | 3 |
| 8 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 2 | 20 |
| 9 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Kelun Pharmaceutical Co., Ltd. | 12 | 3 | 0 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 7 | 4 | 1 |
| 4 | Novo Nordisk A/S | 6 | 2 | 0 |
| 5 | AstraZeneca UK Limited | 6 | 1 | 0 |
| 6 | Bayer Inc. | 6 | 1 | 0 |
| 7 | Guizhou Hao Cheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Shanghai Shuo Di Bio Technology Co., Ltd. romanized | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/06Import · Class 1 | BAY 3401016 注射液 · No verified English nameJXSL2500141 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/08/06Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2502844 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/08/06Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2502839 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized |
| 2025/08/06Generic · Class 3 | Piracetam InjectionCYHS2502825 | Hua Zhong Pharma Co., Ltd. romanized |
| 2025/08/06Generic · Class 3 | Piracetam InjectionCYHS2502824 | Hua Zhong Pharma Co., Ltd. romanized |
| 2025/08/06New drug · Class 3.1 | 清肺汤颗粒 · No verified English nameCXZS2500032 | Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized |
| 2025/08/06New drug · Class 1.1 | 黄葶肺心平颗粒 · No verified English nameCXZL2500063 | Chongqing Xi Er An Pharma Co., Ltd. romanized |
| 2025/08/06New drug · Class 3.4 | 破伤风人免疫球蛋白 · No verified English nameCXSS2500078 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2025/08/06New drug · Class 1 | 注射用间充质干细胞(脐带) · No verified English nameCXSL2500661 | Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized |
| 2025/08/06New drug · Class 1 | IBI3026 · No verified English nameCXSL2500660 | Xin Da Bio Technology Co., Ltd. romanized |
| 2025/08/06New drug · Class 2.4 | 瑞维鲁胺片 · No verified English nameCXHL2500815 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/06New drug · Class 1 | IPG7236片 · No verified English nameCXHL2500814 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/06New drug · Class 1 | IPG7236片 · No verified English nameCXHL2500813 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/05Import · Class 2.2 | Lebrikizumab注射液 · No verified English nameJXSL2500140 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/05Import · Class 1 | AZD0486 · No verified English nameJXSL2500139 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/05Import · Class 1 | AZD0486 · No verified English nameJXSL2500138 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/05Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2502823 | CISEN PHARMACEUTICAL CO., LTD. |
| 2025/08/05Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2502821 | Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | 异丙托溴铵沙丁胺醇吸入喷雾剂 · No verified English nameCYHS2502820 | Nanchang Gu Sen Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | Ebastine Oral SolutionCYHS2502814 | Chongqing Xi Er An Pharma Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502813 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.3 | 小儿肺热咳喘口服液 · No verified English nameCXZL2500062 | Heilongjiang Kui Hua Pharma Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | QLS2309注射液 · No verified English nameCXSL2500659 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/05New drug · Class 1 | SYS6010 · No verified English nameCXSL2500658 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | IBI3009 · No verified English nameCXSL2500657 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | SYS6043 · No verified English nameCXSL2500656 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | DP303c注射液 · No verified English nameCXSL2500655 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | SYS6002 · No verified English nameCXSL2500654 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 3.3 | 精蛋白人胰岛素混合注射液(30R) · No verified English nameCXSL2500653 | Heng Jing He Chuang Biopharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2500091 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
77 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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