YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 389 drug applications between 27 March 2026 and 2 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 36 drug names.
2026/03/27 – 2026/04/02
- New acceptances this week
- 389
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- Accepted this week, now under review
- 101
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
389filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 240 |
| New drug | 59 |
| Generic | 48 |
| Import | 18 |
| Unspecified | 12 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 138 |
| Therapeutic biologic | 52 |
| Biologic | 2 |
| 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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 3 | 2 | 61 |
| 2 | Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets | 3 | 1 | 3 |
| 3 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 4 | Linagliptin and Metformin Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 5 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 6 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 7 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 8 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 9 | Labetalol Hydrochloride Tablets | 2 | 1 | 3 |
| 10 | 褪黑素颗粒 · No verified English name | 2 | 1 | 12 |
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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Dong E E Jiao Co., Ltd. romanized | 11 | 9 | 0 |
| 2 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 3 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 4 | Jiangsu Ke Lun Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Henan Nuo Mei Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | AstraZeneca AB | 5 | 4 | 0 |
| 8 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Takeda Development Center Americas Inc. | 5 | 1 | 0 |
| 10 | Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/02Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600027 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S. p. A.; MSD R&D (China) Co. Ltd |
| 2026/04/02Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600026 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/04/02Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSS2600025 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/04/02Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSS2600024 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2026/04/02Import · Class 1 | PF-08634404 · No verified English nameJXSL2600089 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/04/02Import · Class 1 | AZD8965片 · No verified English nameJXHL2600098 | AstraZeneca AB; Name not romanized |
| 2026/04/02Import · Class 1 | AZD8965片 · No verified English nameJXHL2600097 | AstraZeneca AB; Name not romanized |
| 2026/04/02Import · Class 2.4 | 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2600096 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd |
| 2026/04/02New drug · Class 1 | 普那利单抗注射液 · No verified English nameCXSL2600373 | Tian Jing Bio Pharma (Hangzhou) Co., Ltd. romanized |
| 2026/04/02New drug · Class 1 | 注射用Efimosfermin alfa · No verified English nameCXSL2600372 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2026/04/02New drug · Class 1 | 注射用GenSci136 · No verified English nameCXSL2600371 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/04/02New drug · Class 1 | CB03-154片 · No verified English nameCXHL2600403 | Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/01Import · Class 2.2 | Depemokimab注射液 · No verified English nameJXSL2600088 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/04/01Import · Class 1 | ASP3082注射液 · No verified English nameJXHL2600095 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/04/01Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHS2600762 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/01New drug · Class 1.1 | ZYY-768颗粒 · No verified English nameCXZL2600033 | Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600060 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600059 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600058 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600057 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600056 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600055 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600054 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600053 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600052 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600051 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2026/04/01New drug · Class 1 | LNF2401注射液(皮下注射) · No verified English nameCXSL2600370 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/04/01New drug · Class 1 | LNF2401注射液(静脉滴注) · No verified English nameCXSL2600369 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/04/01New drug · Class 1 | CMG2349注射液 · No verified English nameCXSL2600368 | Chengdu En Mu Bio Technology Co., Ltd. romanized |
| 2026/04/01New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2600367 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
56 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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