YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 18 April 2025 and 24 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 66 drug names.
2025/04/18 – 2025/04/24
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 40
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
290filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 138 |
| Generic | 81 |
| New drug | 37 |
| Import | 25 |
| Unspecified | 4 |
| Import re-registration | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 50 |
| Therapeutic biologic | 32 |
| Prophylactic biologic | 4 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 2 | 草酸艾司西酞普兰口服溶液 · No verified English name | 2 | 2 | 11 |
| 3 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 4 | Tacrolimus Ointment | 2 | 1 | 6 |
| 5 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | 布美他尼片 · No verified English name | 2 | 1 | 8 |
| 8 | Cariprazine hydrochloride Capsules | 2 | 1 | 3 |
| 9 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
| 10 | Propranolol Hydrochloride Injection | 2 | 1 | 4 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 12 | 1 | 0 |
| 2 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized | 4 | 4 | 1 |
| 5 | Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Guizhou Bei Bi Qiang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 8 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 2 | 3 |
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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500099 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500098 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500097 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500096 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500095 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500094 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Generic · Class 3 | Bifonazole SolutionCYHS2501550 | Nanjing Ai De Kai Teng Biopharmaceuticals Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized |
| 2025/04/24Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2501546 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2025/04/24Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2501544 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2025/04/24Generic · Class 3 | Progesterone InjectionCYHS2501540 | Henan Ke Lun Pharma Co., Ltd. romanized |
| 2025/04/24New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSS2500049 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2025/04/24New drug · Class 1.2 | 二价重组呼吸道合胞病毒疫苗(CHO 细胞) · No verified English nameCXSL2500331 | Zhejiang San Ye Cao Biopharmaceutical Co., Ltd. romanized |
| 2025/04/24New drug · Class 1 | CTM012注射液 · No verified English nameCXSL2500330 | Le Pu Chuang Yi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/04/24New drug · Class 1 | 注射用ICP-B794 · No verified English nameCXSL2500329 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/24New drug · Class 1 | 注射用TQB2934 · No verified English nameCXSL2500328 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/24New drug · Class 1 | 注射用BGB-B2033 · No verified English nameCXSL2500327 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/04/23Import · Class 1 | 尼卡利单抗注射液 · No verified English nameJXSS2500050 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2025/04/23Import · Class 1 | 尼卡利单抗注射液 · No verified English nameJXSS2500049 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2025/04/23Import · Class 1 | Relatlimab注射液 · No verified English nameJXSL2500063 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500093 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500092 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500091 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500090 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500089 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500088 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | 注射用KSP-1007-05 · No verified English nameJXHL2500087 | Sumitomo Pharma Co. Ltd. |
| 2025/04/23Generic · Class 3 | Gliclazide TabletsCYHS2501529 | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501528 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501527 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501526 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
57 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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