YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 495 drug applications between 24 April 2026 and 30 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 68 drug names.
2026/04/24 – 2026/04/30
- New acceptances this week
- 495
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 134
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
495filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 284 |
| Generic | 82 |
| New drug | 69 |
| Import | 33 |
| Unspecified | 16 |
| Import re-registration | 10 |
| Import (made outside China) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 188 |
| Therapeutic biologic | 58 |
| Biologic | 9 |
| Prophylactic biologic | 5 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Loxoprofen Sodium Patches | 4 | 2 | 30 |
| 2 | Pemafibrate Tablets | 2 | 2 | 23 |
| 3 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 17 |
| 4 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III) | 2 | 2 | 12 |
| 5 | Celecoxib Tablets | 2 | 1 | 3 |
| 6 | Levetiracetam Tablets | 2 | 1 | 6 |
| 7 | 左奥硝唑氯化钠注射液 · No verified English name | 2 | 1 | 5 |
| 8 | Lidocaine Hydrochloride Gel | 2 | 1 | 8 |
| 9 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 10 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 1 | 3 |
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
280 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 17 | 2 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 16 | 10 | 0 |
| 3 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Novo Nordisk A/S | 8 | 4 | 0 |
| 5 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 7 | 5 | 0 |
| 7 | Qinghai Sheng Tong Tian He Zang Yao Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 5 | 0 |
| 9 | Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 10 | Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/30Import · Class 1 | BAY 2433334片 · No verified English nameJXHS2600043 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/04/30Import · Class 2.4 | 盐酸阿曲生坦片 · No verified English nameJXHL2600139 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/04/30Generic · Class 3 | Ebastine Oral SolutionCYHS2601012 | Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/04/30Generic · Class 3 | Celecoxib TabletsCYHS2601011 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized |
| 2026/04/30Generic · Class 3 | Celecoxib TabletsCYHS2601010 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized |
| 2026/04/30Generic · Class 3 | 右美沙芬安非他酮缓释片 · No verified English nameCYHS2601007 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2026/04/30Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2601006 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized |
| 2026/04/30Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2601004 | Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | 万基奥仑赛注射液 · No verified English nameCXSS2600077 | Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | 乐德奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600076 | Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | 乐德奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600075 | Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | 注射用培重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2600074 | Hangzhou Cheng Si Biopharmaceutical Co., Ltd. romanized; Cheng Si (Shanghai) Biopharmaceutical Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | 注射用培重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2600073 | Hangzhou Cheng Si Biopharmaceutical Co., Ltd. romanized; Cheng Si (Shanghai) Biopharmaceutical Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | SKB118注射液 · No verified English nameCXSL2600463 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/30New drug · Class 1.4 | 重组四价肠道病毒疫苗(汉逊酵母) · No verified English nameCXSL2600457 | Wei Er Tai Ke (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | BW-41012注射液 · No verified English nameCXHL2600524 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | GLR2038片 · No verified English nameCXHL2600522 | Gan Li Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | GLR2038片 · No verified English nameCXHL2600521 | Gan Li Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 2.2 | DYTH203 · No verified English nameCXHL2600520 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | SAL0167片 · No verified English nameCXHL2600519 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | SAL0167片 · No verified English nameCXHL2600518 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/04/30New drug · Class 1 | SAL0167片 · No verified English nameCXHL2600517 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/04/29Import · Class 1 | RO7435846片 · No verified English nameJXHL2600138 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片 · No verified English nameJXHL2600137 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片 · No verified English nameJXHL2600136 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片 · No verified English nameJXHL2600135 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Generic · Class 3 | 碘化钾片 · No verified English nameCYHS2601003 | Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized |
| 2026/04/29Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601002 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2026/04/29Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHS2600999 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2026/04/29New drug · Class 1.1 | CS001 胶囊 · No verified English nameCXZL2600038 | Suzhou Chong Sheng Pharmaceuticals Technology Co., Ltd. romanized |
92 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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