YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 345 drug applications between 22 September 2026 and 28 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 37 drug names.
2026/09/22 – 2026/09/28
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 278
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
345filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| New drug | 54 |
| Generic | 47 |
| Import | 34 |
| Import re-registration | 16 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 185 |
| TCM | 91 |
| Therapeutic biologic | 62 |
| Biologic | 5 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Baricitinib Tablets | 3 | 2 | 32 |
| 2 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 3 | 盐酸西替利嗪滴眼液 · No verified English name | 2 | 2 | 3 |
| 4 | Brimonidine Tartrate Eye Drops | 2 | 2 | 4 |
| 5 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 6 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 7 | Repaglinide Tablets | 2 | 1 | 6 |
| 8 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 9 | Axitinib Tablets | 2 | 1 | 5 |
| 10 | Dexketoprofen Trometamol Injection | 1 | 1 | 6 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 9 | 1 | 0 |
| 2 | Pfizer Inc. | 9 | 1 | 0 |
| 3 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Shaanxi Ou Ke Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Xian Wan Long Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Shanxi Wang Long Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Yuan Da Bei Lin (Xian) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Te Yi Pharma Group Co., Ltd. romanized | 4 | 2 | 2 |
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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600426 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | Giredestrant胶囊 · No verified English nameJXHL2600425 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600424 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | Giredestrant胶囊 · No verified English nameJXHL2600423 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600422 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600421 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600420 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600419 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060 · No verified English nameJXHL2600418 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Generic · Class 3 | 溴吡斯的明口服溶液 · No verified English nameCYHS2602419 | Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2026/09/28Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2602416 | Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized |
| 2026/09/28Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2602415 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/28New drug · Class 1.1 | 消肿颗粒 · No verified English nameCXZL2600095 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2026/09/28New drug · Class 2.4 | 注射用重组A型肉毒毒素(150 kD) · No verified English nameCXSS2600156 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | 注射用AP308 · No verified English nameCXSL2601066 | Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | 9MW2821 · No verified English nameCXSL2601065 | Mai Wei (Shang Tao) Bio Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | YYSW001片 · No verified English nameCXHL2601211 | Yi You Bio (Shanghai) Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Meng Yang Pharma (Shanghai) Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | 注射用TNP-2092 · No verified English nameCXHL2601210 | Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | BG-92505片 · No verified English nameCXHL2601209 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | BG-92505片 · No verified English nameCXHL2601208 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | 注射用莱古比星 · No verified English nameCXHL2601207 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | YKYY018雾化吸入剂 · No verified English nameCXHL2601206 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/28New drug · Class 1 | YKYY018雾化吸入剂 · No verified English nameCXHL2601205 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/24Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2600260 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/24Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2600123 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2600122 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | 赛沃替尼片 · No verified English nameJXHL2600417 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
72 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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