YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 460 drug applications between 7 July 2026 and 13 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 54 drug names.
2026/07/07 – 2026/07/13
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- 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
460filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 253 |
| New drug | 85 |
| Generic | 65 |
| Import | 31 |
| Unspecified | 17 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 232 |
| TCM | 134 |
| Therapeutic biologic | 81 |
| Biologic | 7 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氧 · No verified English name | 3 | 3 | 15 |
| 2 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 3 | Dotinurad Tablets | 2 | 1 | 55 |
| 4 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 5 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 6 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 7 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 8 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 9 | Nadroparin Calcium Injection | 2 | 1 | 6 |
| 10 | Estradiol Gel | 2 | 1 | 8 |
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
292 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 2 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | Novo Nordisk A/S | 7 | 2 | 0 |
| 4 | Shanxi Ao Er Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Amgen Inc. | 6 | 1 | 0 |
| 7 | Liquidia Technologies Inc. | 6 | 1 | 0 |
| 8 | Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Gui Lin San Jin Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Patheon France | 5 | 1 | 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
141 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/07/13New drug · Class 3.1 | 当归饮子颗粒 · No verified English nameCXZS2600036 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized |
| 2026/07/13New drug · Class 1.1 | 糖宁通络乳膏 · No verified English nameCXZL2600060 | Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | Sac002注射液 · No verified English nameCXSL2600735 | Zhong Mei Sai Er Bio Technology (Guangdong) Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | HS-20117-2注射液 · No verified English nameCXSL2600734 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | 注射用AK158D1 · No verified English nameCXSL2600733 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | BNT317注射液 · No verified English nameCXSL2600732 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | Cizutamig注射液(皮下注射) · No verified English nameCXSL2600731 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/13New drug · Class 2.4 | 苯磺酸克利加巴林胶囊 · No verified English nameCXHS2600102 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/07/13New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2600846 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | ABP-745缓释片A · No verified English nameCXHL2600845 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | ABP-745缓释片B · No verified English nameCXHL2600844 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2026/07/13New drug · Class 2.3 | EP-0229T · No verified English nameCXHL2600843 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2026/07/13New drug · Class 1 | BCR-0008片 · No verified English nameCXHL2600842 | Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized |
111 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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