YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 454 drug applications between 9 April 2026 and 15 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 61 drug names.
2026/04/09 – 2026/04/15
- New acceptances this week
- 454
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 120
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
454filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 254 |
| Generic | 82 |
| New drug | 64 |
| Import | 32 |
| Import re-registration | 15 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 237 |
| TCM | 138 |
| Therapeutic biologic | 75 |
| Biologic | 4 |
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
61 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 Solution For Inhalation | 3 | 1 | 10 |
| 3 | Topiramate Extended-release Capsules | 3 | 1 | 0 |
| 4 | Crisaborole Ointment | 2 | 2 | 26 |
| 5 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 6 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Levetiracetam in Sodium Chloride Injection | 2 | 1 | 2 |
| 9 | Ibuprofen Suspension | 2 | 1 | 14 |
| 10 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
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
259 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Wan Sui Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 7 | 4 | 0 |
| 3 | Merck Sharp & Dohme B.V. | 6 | 2 | 0 |
| 4 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Novo Nordisk A/S | 6 | 1 | 0 |
| 6 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/04/15New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600066 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | 注射用6MW5311 · No verified English nameCXSL2600410 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | MRG007 · No verified English nameCXSL2600409 | Le Pu Bio Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | 注射用KGX105 · No verified English nameCXSL2600408 | Beijing Kang Kang Bio Technology Co., Ltd. romanized; Shanghai Kang Kang Bio Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | BBT002皮下注射液 · No verified English nameCXSL2600407 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | BBT002皮下注射液 · No verified English nameCXSL2600406 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | 注射用莱古杉醇 · No verified English nameCXHL2600450 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | 注射用莱古杉醇 · No verified English nameCXHL2600449 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | [177Lu]Lu-XT381注射液 · No verified English nameCXHL2600441 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | IPG1094片 · No verified English nameCXHL2600440 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | IPG1094片 · No verified English nameCXHL2600439 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | IPG1094片 · No verified English nameCXHL2600438 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/15New drug · Class 1 | IPG1094片 · No verified English nameCXHL2600437 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/14Import · Class 1 | Admilparant片 · No verified English nameJXHL2600114 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2026/04/14Import · Class 1 | Admilparant片 · No verified English nameJXHL2600113 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2026/04/14Import · Class 1 | Admilparant片 · No verified English nameJXHL2600112 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2026/04/14Generic · Class 3 | Fenofibrate TabletsCYHS2600859 | You Hui Pharma (Beijing) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/04/14Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2600858 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2026/04/14Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2600857 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2026/04/14Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600856 | Hubei Tai Zi Pharma Co., Ltd. romanized |
| 2026/04/14Generic · Class 3 | 尿素[13C]片呼气试验药盒 · No verified English nameCYHS2600854 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2026/04/14New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2600065 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
101 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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