YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 259 drug applications between 28 May 2026 and 3 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 44 drug names.
2026/05/28 – 2026/06/03
- New acceptances this week
- 259
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 85
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
259filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 134 |
| Generic | 66 |
| New drug | 42 |
| Import | 12 |
| Unspecified | 3 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 145 |
| TCM | 70 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 3 |
| Biologic | 1 |
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
44 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 | 4 | 3 | 10 |
| 4 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 5 | Sivelestat Sodium for Injection | 2 | 2 | 5 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Mecobalamin Tablets | 2 | 2 | 16 |
| 8 | 口服溶液用盐酸万古霉素 · No verified English name | 2 | 1 | 2 |
| 9 | Dotinurad Tablets | 2 | 1 | 55 |
| 10 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
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
179 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 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 6 | 2 | 6 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 4 | Guo Yao Group Xinjiang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Amgen Inc. | 4 | 2 | 0 |
| 6 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 7 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Pfizer Inc. | 3 | 2 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/03Generic · Class 3 | 头孢呋辛酯干混悬剂 · No verified English nameCYHS2601293 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2026/06/03Generic · Class 3 | Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2601286 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/06/03Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601281 | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2026/06/03Generic · Class 3 | Sivelestat Sodium for InjectionCYHS2601279 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/06/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601258 | Jiangxi Ban Bian Tian Pharma Co., Ltd. romanized |
| 2026/06/02Generic · Class 3 | 磷酸二氢钠磷酸氢二钠颗粒 · No verified English nameCYHS2601253 | Yi Chun Kang Er Xin Pharma Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | IBI3014 · No verified English nameCXSL2600594 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | 注射用LB4330 · No verified English nameCXSL2600593 | Jian Xin Bio Technology (Ningbo) Co., Ltd. romanized; Jian Xin Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | VG712注射液 · No verified English nameCXSL2600592 | Chengdu Wei Jin Bai Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2600591 | Jian Xin Bio Technology (Ningbo) Co., Ltd. romanized; Jian Xin Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | 注射用MC002 · No verified English nameCXSL2600590 | Hangzhou Mai Lian Ke Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | DC7001A胶囊 · No verified English nameCXHL2600646 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | DC7001A胶囊 · No verified English nameCXHL2600645 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | DC7001A胶囊 · No verified English nameCXHL2600644 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 2026/06/02New drug · Class 1 | DC7001A胶囊 · No verified English nameCXHL2600643 | Beijing Shuang He Run Chuang Technology Co., Ltd. romanized |
| 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 |
55 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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