YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 465 drug applications between 8 July 2026 and 14 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 50 drug names.
2026/07/08 – 2026/07/14
- New acceptances this week
- 465
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 131
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
465filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 268 |
| New drug | 80 |
| Generic | 57 |
| Import | 31 |
| Unspecified | 21 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 230 |
| TCM | 145 |
| Therapeutic biologic | 76 |
| Biologic | 8 |
| Prophylactic biologic | 6 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氧 · No verified English name | 2 | 2 | 15 |
| 2 | Dotinurad Tablets | 2 | 1 | 55 |
| 3 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 4 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 5 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 6 | Minoxidil Liniment | 2 | 1 | 52 |
| 7 | Estradiol Gel | 2 | 1 | 8 |
| 8 | Ethyl Iosapentate Capsules | 1 | 1 | 27 |
| 9 | 二甲硅油乳剂 · No verified English name | 1 | 1 | 14 |
| 10 | Edaravone and Dexborneol Concentrated Solution for Injection | 1 | 1 | 34 |
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
285 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 10 | 2 | 0 |
| 2 | Shanxi Ao Er Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 4 | Novo Nordisk A/S | 7 | 2 | 0 |
| 5 | Amgen Inc. | 6 | 1 | 0 |
| 6 | Liquidia Technologies Inc. | 6 | 1 | 0 |
| 7 | Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Gui Lin San Jin Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 3 | 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
136 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/14Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2600164 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/07/14Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2600163 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/07/14Generic · Class 3 | Mepivacaine Hydrochloride InjectionCYHS2601677 | Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2026/07/14Generic · Class 3 | Minoxidil LinimentCYHS2601676 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2026/07/14Generic · Class 3 | Minoxidil LinimentCYHS2601675 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2600737 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | TQB2922注射液(皮下注射) · No verified English nameCXSL2600736 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | HRS-4729注射液 · No verified English nameCXHL2600852 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | HRS-4729注射液 · No verified English nameCXHL2600851 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | PRJ1-3024胶囊 · No verified English nameCXHL2600850 | Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized |
| 2026/07/14New drug · Class 1 | PRJ1-3024胶囊 · No verified English nameCXHL2600849 | Guangzhou Yu Fan Nan Tu Bio Technology Co., Ltd. romanized |
| 2026/07/14New drug · Class 2.3 | BTP0427 · No verified English nameCXHL2600848 | 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 |
| 2026/07/14New drug · Class 2.3 | BTP0427 · No verified English nameCXHL2600847 | 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 |
| 2026/07/13Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2600062 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600162 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600161 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600160 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600159 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600158 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133 · No verified English nameJXSL2600157 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600272 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600271 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600270 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600269 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Generic · Class 3 | 盐酸奥洛他定口崩片 · No verified English nameCYHS2601670 | Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized |
| 2026/07/13Generic · Class 3 | Clemastine Fumarate InjectionCYHS2601666 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/07/13Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601664 | Hebei Shan Mu Shi Pharma Co., Ltd. romanized |
| 2026/07/13Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601663 | Hebei Shan Mu Shi Pharma Co., Ltd. romanized |
| 2026/07/13Generic · Class 3 | 唑尼沙胺胶囊 · No verified English nameCYHS2601662 | Hunan Shang Zhong He Biopharmaceuticals Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2026/07/13Generic · Class 3 | Pirfenidone TabletsCYHS2601659 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
106 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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