YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 26 May 2026 and 1 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 38 drug names.
2026/05/26 – 2026/06/01
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 90
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
360filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 229 |
| Generic | 56 |
| New drug | 42 |
| Import | 19 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 131 |
| Therapeutic biologic | 46 |
| Biologic | 5 |
| Prophylactic biologic | 5 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲硝唑凝胶 · No verified English name | 5 | 3 | 14 |
| 2 | Sufentanil Citrate Injection | 5 | 1 | 0 |
| 3 | Chloroprocaine Hydrochloride Injection | 3 | 2 | 10 |
| 4 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 5 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 6 | 口服溶液用盐酸万古霉素 · No verified English name | 2 | 1 | 2 |
| 7 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
| 8 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
| 9 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 10 | Dapagliflozin Tablets | 2 | 1 | 84 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Changsha Dong Feng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 6 | 2 | 6 |
| 4 | Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 6 | Guo Yao Group Xinjiang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 8 | Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Kyowa Kirin Co. Ltd. | 4 | 2 | 0 |
| 10 | Eli Lilly Nederland B.V. | 4 | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/01Import · Class 2.2 | 尼卡利单抗注射液 · No verified English nameJXSS2600045 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/06/01Import · Class 2.2 | 尼卡利单抗注射液 · No verified English nameJXSS2600044 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/06/01Import · Class 1 | ABBV-1758注射液 · No verified English nameJXSL2600125 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/06/01Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2600124 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/06/01Import · Class 1 | LY4257496注射液 · No verified English nameJXHL2600193 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/06/01Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2601244 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2601243 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Sivelestat Sodium for InjectionCYHS2601242 | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Polycarbophil Calcium TabletsCYHS2601241 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601237 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601236 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | 葡萄糖酸氯己定含漱液 · No verified English nameCYHS2601233 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Potassium Phosphates InjectionCYHS2601232 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2601230 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Probucol TabletsCYHS2601226 | Ningxia Kang Ya Pharma Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601220 | Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601219 | Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2026/06/01Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2601218 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2026/06/01New drug · Class 2.3 | 灵莲花颗粒 · No verified English nameCXZL2600050 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | GR2302注射液(皮下注射) · No verified English nameCXSL2600589 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | GR2302注射液(皮下注射) · No verified English nameCXSL2600588 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | GR2302注射液 · No verified English nameCXSL2600587 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | SHR-1179注射液 · No verified English nameCXSL2600586 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | 伊匹乌肽散剂 · No verified English nameCXHL2600642 | Wen Zhou Yi Cheng Jing Zhan Bio Technology Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | 注射用APG-1252 · No verified English nameCXHL2600641 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | TRI-611片 · No verified English nameCXHL2600640 | Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/01New drug · Class 1 | TRI-611片 · No verified English nameCXHL2600639 | Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/29Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSS2600043 | Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2026/05/29Import · Class 1 | INCA33890注射液 · No verified English nameJXSL2600123 | Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd. |
| 2026/05/29Import · Class 1 | Ponsegromab注射液 · No verified English nameJXSL2600122 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
61 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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