YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 309 drug applications between 21 September 2022 and 27 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 46 drug names.
2022/09/21 – 2022/09/27
- New acceptances this week
- 309
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 0
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
309filings, 52 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 154 |
| New drug | 57 |
| Generic | 52 |
| Unspecified | 19 |
| Import | 19 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 217 |
| Therapeutic biologic | 49 |
| TCM | 28 |
| Biologic | 14 |
| In vitro diagnostic reagent | 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 2 | Allopurinol Tablets | 2 | 1 | 4 |
| 3 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 4 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 5 | Choline Fenofibrate Sustained-release Capsules | 2 | 1 | 1 |
| 6 | Acetylcysteine Granules | 1 | 1 | 4 |
| 7 | Tacrolimus Sustained-release Capsules | 1 | 1 | 6 |
| 8 | Tafluprost Eye Drops | 1 | 1 | 3 |
| 9 | Lidocaine Cataplasms | 1 | 1 | 7 |
| 10 | Indobufen Tablets | 1 | 1 | 6 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Mei Lin Pharma Co., Ltd. romanized | 22 | 16 | 0 |
| 2 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 22 | 16 | 0 |
| 3 | Shanghai Yan An Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Vetter Pharma-Fertigung GmbH & Co. KG | 8 | 2 | 0 |
| 5 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 7 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Takeda Development Center Americas Inc. | 4 | 2 | 0 |
| 10 | Changchun Jin Sai Pharma Co., Ltd. romanized | 4 | 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/27Generic · Class 3 | Pentoxifylline InjectionCYHS2201620 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2022/09/27Generic · Class 3 | Potassium Aspartate InjectionCYHS2201618 | Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2022/09/27New drug · Class 1.1 | 傣肾宁颗粒 · No verified English nameCXZL2200044 | Xi Shuang Ban Na Dai Zu Zi Zhi Zhou Dai Yi Hospital romanized |
| 2022/09/27New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSS2200082 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/09/27New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSS2200081 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/09/27New drug · Class 3.4 | 重组人促卵泡激素注射液 · No verified English nameCXSS2200080 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | PM1103注射液 · No verified English nameCXSL2200490 | Pu Mi Si Biopharmaceutical (Nan Tong) Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | 注射用AP026 · No verified English nameCXSL2200489 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | JY47注射液 · No verified English nameCXSL2200488 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | BRG01注射液 · No verified English nameCXSL2200487 | Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | GR2001注射液 · No verified English nameCXSL2200485 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | 注射用LH021 · No verified English nameCXHL2200736 | Guangzhou Ling Cheng Medical Technology Co., Ltd. romanized |
| 2022/09/27New drug · Class 1 | XNW7201片 · No verified English nameCXHL2200735 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/26Generic · Class 3 | Allopurinol TabletsCYHS2201610 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/09/26Generic · Class 3 | Allopurinol TabletsCYHS2201609 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/09/26New drug · Class 1 | 重组人源化单克隆抗体MIL93注射液 · No verified English nameCXSL2200483 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2022/09/26New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200482 | Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/25Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201608 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2022/09/25Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201607 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2022/09/24Import · Class 1 | ALXN1720注射液 · No verified English nameJXSL2200172 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Futuximab/Modotuximab 注射液 (S95026) · No verified English nameJXSL2200171 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development CO. LTD |
| 2022/09/24Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2200294 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2200293 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/09/24Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2201604 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 2.3 | 养正消积胶囊 · No verified English nameCXZL2200043 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2200481 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | GC301腺相关病毒注射液 · No verified English nameCXSL2200480 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 注射用QLS31903 · No verified English nameCXSL2200479 | Qilu Pharmaceutical Co., Ltd. |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200048 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2022/09/24New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200047 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
56 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.