YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 22 April 2025 and 28 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 77 drug names.
2025/04/22 – 2025/04/28
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 43
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
396filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 97 |
| New drug | 61 |
| Import | 33 |
| Unspecified | 11 |
| Import re-registration | 3 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 287 |
| TCM | 59 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 7 |
| Biologic | 3 |
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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pemafibrate Tablets | 4 | 4 | 23 |
| 2 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 3 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 4 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 5 | 草酸艾司西酞普兰口服溶液 · No verified English name | 2 | 2 | 11 |
| 6 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 7 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 8 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 16 | 10 | 0 |
| 2 | Eli Lilly and Company | 14 | 2 | 0 |
| 3 | Janssen-Cilag International NV | 9 | 4 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 5 | Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 3 |
| 10 | Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized | 4 | 4 | 1 |
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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/28Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2500051 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/04/28Import · Class 1 | VHB937注射用浓溶液 · No verified English nameJXSL2500065 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/28Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2501595 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/04/28Generic · Class 3 | 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2501592 | Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2025/04/28Generic · Class 3 | Benzbromarone TabletsCYHS2501591 | Zhejiang Jiang Bei Pharma Co., Ltd. romanized |
| 2025/04/28Generic · Class 3 | Ferrous Succinate TabletsCYHS2501589 | Shaanxi Ju Cheng Biopharmaceuticals Manufacturing Li Cu Jin Center Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/04/28Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2501587 | Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2500027 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2500026 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500338 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 注射用DB-1311 · No verified English nameCXSL2500337 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500336 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500335 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 注射用SKB518 · No verified English nameCXSL2500334 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2500333 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500332 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500042 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500041 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | 索托克拉片 · No verified English nameCXHS2500040 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 左氨氯地平比索洛尔片(Ⅱ) · No verified English nameCXHS2500039 | Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.3 | 左氨氯地平比索洛尔片(Ⅰ) · No verified English nameCXHS2500038 | Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | OLP-210片 · No verified English nameCXHL2500423 | Shenzhen Ao Li Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | OLP-210片 · No verified English nameCXHL2500422 | Shenzhen Ao Li Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | OLP-210片 · No verified English nameCXHL2500421 | Shenzhen Ao Li Bio Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | 雷美替胺双释片 · No verified English nameCXHL2500420 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2500419 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | ABP-745片 · No verified English nameCXHL2500418 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | ABP-745片 · No verified English nameCXHL2500417 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2025/04/28New drug · Class 1 | ABP-745片 · No verified English nameCXHL2500416 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2025/04/28New drug · Class 2.2 | WS-019 · No verified English nameCXHL2500415 | Hubei Wu Shi Pharma Co., Ltd. romanized |
92 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.