YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 308 drug applications between 23 September 2026 and 29 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 39 drug names.
2026/09/23 – 2026/09/29
- New acceptances this week
- 308
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- Accepted this week, now under review
- 258
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
308filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| New drug | 55 |
| Generic | 45 |
| Import | 37 |
| Import re-registration | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 165 |
| TCM | 89 |
| Therapeutic biologic | 52 |
| Biologic | 1 |
| Prophylactic 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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Edaravone and Dexborneol Concentrated Solution for Injection | 3 | 3 | 34 |
| 2 | Baricitinib Tablets | 2 | 1 | 32 |
| 3 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 4 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 5 | Atorvastatin Calcium Tablets | 2 | 1 | 24 |
| 6 | 利多卡因丙胺卡因气雾剂 · No verified English name | 1 | 1 | 5 |
| 7 | Dexketoprofen Trometamol Injection | 1 | 1 | 6 |
| 8 | 复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液 · No verified English name | 1 | 1 | 2 |
| 9 | Dolutegravir Sodium Tablets | 1 | 1 | 3 |
| 10 | 多种微量元素注射液(IV) · No verified English name | 1 | 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
207 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 16 | 3 | 0 |
| 2 | Shaanxi Ou Ke Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 6 | Shanxi Wang Long Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Te Yi Pharma Group Co., Ltd. romanized | 4 | 2 | 2 |
| 8 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 9 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 3 | 3 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600435 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600434 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525 · No verified English nameJXHL2600433 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600432 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600431 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600430 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600429 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Generic · Class 3 | Calcitriol Oral SolutionCYHS2602431 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | Hydrotalcite SuspensionCYHS2602427 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | 多种微量元素注射液(IV) · No verified English nameCYHS2602425 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2026/09/29Generic · Class 3 | Simethicone Chewable TabletsCYHS2602422 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 3.4 | 替瑞奇珠单抗注射液 · No verified English nameCXSS2600157 | Cheng Hua Pharma (Hainan) Co., Ltd. romanized; Xia Er Ba Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | HL99自体T细胞注射液 · No verified English nameCXSL2601076 | Henan Sheng Hua Long Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | SIM0725注射液 · No verified English nameCXSL2601075 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized; Xian Sheng Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用SIM0505 · No verified English nameCXSL2601074 | Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用BG-T187(皮下注射) · No verified English nameCXSL2601073 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用YL413 · No verified English nameCXSL2601072 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | 注射用HCRB001 · No verified English nameCXSL2601071 | Haikou Tie Shu Da Fang Bio Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | MK-8748眼内注射溶液 · No verified English nameCXSL2601070 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/29New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2601069 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | CG101细胞注射液 · No verified English nameCXSL2601068 | Hangzhou Ji Yuan Ji Yin Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | LK101注射液 · No verified English nameCXSL2601067 | Beijing Li Kang Sheng Ming Technology Co., Ltd. romanized |
| 2026/09/29New drug · Class 2.4 | 玛仕度肽注射液 · No verified English nameCXHL2601216 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/29New drug · Class 2.1; 2.4 | SAL0120CSA片 · No verified English nameCXHL2601215 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 2.1; 2.4 | SAL0120CSA片 · No verified English nameCXHL2601214 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | KR23343片 · No verified English nameCXHL2601213 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/09/29New drug · Class 1 | KR23343片 · No verified English nameCXHL2601212 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/09/28Import · Class 1 | AMG 732 · No verified English nameJXSL2600261 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600428 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600427 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
80 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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