YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 397 drug applications between 16 December 2025 and 22 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 43 drug names.
2025/12/16 – 2025/12/22
- New acceptances this week
- 397
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 89
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
397filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 221 |
| New drug | 81 |
| Generic | 70 |
| Import | 9 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 124 |
| Therapeutic biologic | 67 |
| Biologic | 4 |
| 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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 4 | 1 | 61 |
| 2 | Baricitinib Tablets | 3 | 2 | 32 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 1 | 11 |
| 7 | Nystatin Oral Suspension | 2 | 2 | 3 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 10 | Divalproex Sodium Extended-Release Tablets | 2 | 1 | 0 |
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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 38 | 32 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 12 | 12 | 0 |
| 3 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Novo Nordisk A/S | 8 | 2 | 0 |
| 5 | Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized | 6 | 4 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 8 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Beijing Lian Er Tang 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/22Import · Class 2.2 | 注射用德达博妥单抗 · No verified English nameJXSS2500151 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH |
| 2025/12/22Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2500244 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/12/22Import · Class 2.2; 2.1 | 泰它西普注射液 · No verified English nameJXSL2500243 | Vor Biopharma Inc.; RemeGen Co. Ltd. |
| 2025/12/22Import · Class 1 | AZD5305 · No verified English nameJXHL2500389 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/12/22Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2504349 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2025/12/22Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2504348 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/12/22Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2504347 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/12/22Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2504346 | Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. |
| 2025/12/22Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2504343 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/12/22Generic · Class 3 | 唑尼沙胺片 · No verified English nameCYHS2504341 | Hunan Shang Zhong He Biopharmaceuticals Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504337 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504336 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2025/12/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504335 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2500143 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 注射用LNF2105 · No verified English nameCXSL2501107 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | NT-001注射液 · No verified English nameCXSL2501106 | Shanghai Nai Kang Bio Technology Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501105 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501104 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 610细胞注射液 · No verified English nameCXSL2501103 | Beijing Ka Ti Medical Technology Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501102 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501101 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 2.2 | 伊基奥仑赛注射液 · No verified English nameCXSL2501100 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | INT-210胶囊 · No verified English nameCXHL2501428 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | INT-210胶囊 · No verified English nameCXHL2501427 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | H021肠溶片 · No verified English nameCXHL2501426 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2025/12/22New drug · Class 2.3 | BTP4327 · No verified English nameCXHL2501425 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501424 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501423 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501422 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2025/12/22New drug · Class 1 | RGT-274-CR胶囊 · No verified English nameCXHL2501419 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
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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