YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 401 drug applications between 10 April 2026 and 16 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 50 drug names.
2026/04/10 – 2026/04/16
- New acceptances this week
- 401
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 103
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
401filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 66 |
| New drug | 65 |
| Import | 24 |
| Import re-registration | 13 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 125 |
| Therapeutic biologic | 68 |
| 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平萨米多芬片 · No verified English name | 4 | 1 | 0 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 4 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 2 | 22 |
| 5 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 6 | Levetiracetam in Sodium Chloride Injection | 2 | 1 | 2 |
| 7 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 8 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 9 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
| 10 | Diphenhydramine Hydrochloride Injection | 2 | 1 | 9 |
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
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 2 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 7 | 4 | 0 |
| 3 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Novo Nordisk A/S | 6 | 1 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 4 | 0 |
| 9 | Hunan Guo Hua Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 4 | 4 | 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
119 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/16Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSS2600037 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2026/04/16Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSS2600036 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2026/04/16Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2600035 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2026/04/16Import · Class 1 | 酒石酸吉雷司群胶囊 · No verified English nameJXHS2600039 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2026/04/16Generic · Class 3 | 蔗糖羟基氧化铁颗粒 · No verified English nameCYHS2600878 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2026/04/16Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2600876 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/04/16Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600872 | Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized |
| 2026/04/16Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600871 | Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized |
| 2026/04/16New drug · Class 1.1 | 小儿辛苍通窍颗粒 · No verified English nameCXZL2600036 | Jian Min Pharma Group Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | 注射用SKB500 · No verified English nameCXSL2600411 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | 注射用甲磺酸普依司他 · No verified English nameCXHL2600456 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600454 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600453 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600452 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600451 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | GW01-200片 · No verified English nameCXHL2600448 | Gao Wei Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | GW01-200片 · No verified English nameCXHL2600447 | Gao Wei Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2026/04/16New drug · Class 1 | TQC5524吸入粉雾剂 · No verified English nameCXHL2600446 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/04/16New drug · Class 1 | TQC5524吸入粉雾剂 · No verified English nameCXHL2600445 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/04/16New drug · Class 1 | TQC5524吸入粉雾剂 · No verified English nameCXHL2600444 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/04/16New drug · Class 1 | TQC5524吸入粉雾剂 · No verified English nameCXHL2600443 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2026/04/16New drug · Class 2.2 | 盐酸艾司氯胺酮口颊粘膜溶液 · No verified English nameCXHL2600442 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/15Import · Class 2.3 | 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600099 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/04/15Generic · Class 3 | Ferrous Succinate TabletsCYHS2600868 | Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized |
| 2026/04/15Generic · Class 3 | 氟[18F]妥司特注射液 · No verified English nameCYHS2600867 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Zhong Shan) Pharmaceuticals Technology Co., Ltd. romanized; Guo Tong (Wuxi) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15Generic · Class 3 | Acetylcysteine TabletsCYHS2600860 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600070 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2026/04/15New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600069 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2026/04/15New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600068 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2026/04/15New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600067 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
89 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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