YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 305 drug applications between 17 August 2022 and 23 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 39 drug names.
2022/08/17 – 2022/08/23
- New acceptances this week
- 305
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- 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
305filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 60 |
| New drug | 46 |
| Import | 20 |
| Import re-registration | 13 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| Therapeutic biologic | 44 |
| TCM | 30 |
| Biologic | 2 |
| Prophylactic 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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Bicarbonate Ringer’s Injection | 4 | 3 | 1 |
| 2 | Magnesium Sulfate Injection | 3 | 1 | 7 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 5 | Gadopentetic Acid Dimeglumine Salt Injection | 3 | 1 | 9 |
| 6 | Peramivir Injection | 2 | 2 | 7 |
| 7 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 8 | Hydrotalcite Suspension | 2 | 2 | 9 |
| 9 | Tadalafil Tablets | 2 | 1 | 23 |
| 10 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
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
168 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Guo Yao Group Gong Ye Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Hubei Mei Lin Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 5 | Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 6 | Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 7 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 3 | 5 |
| 9 | Novartis Pharma AG | 5 | 2 | 0 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/23Import · Class 1 | Peresolimab注射液 · No verified English nameJXSL2200141 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/23Import · Class 1.1 | MVA-BN-RSV疫苗 · No verified English nameJXSL2200138 | Bavarian Nordic A/S; Nuance Pharma (Shanghai) Co. Ltd. |
| 2022/08/23Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2200134 | Merck Sharp &. Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200252 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200251 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200250 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200249 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201367 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201366 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/23Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201365 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/23Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201364 | Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201363 | Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Hydrotalcite SuspensionCYHS2201360 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Peramivir InjectionCYHS2201359 | Wen Zhou Hai He Pharma Co., Ltd. romanized; Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized |
| 2022/08/23Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2201356 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Potassium Chloride InjectionCYHS2201317 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2201316 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2201309 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/23Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2200071 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized |
| 2022/08/23Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2200069 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2022/08/23New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2200075 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2022/08/23New drug · Class 3.4 | 人生长激素注射液 · No verified English nameCXSS2200074 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | IBI110 · No verified English nameCXSL2200397 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | HK010注射液 · No verified English nameCXSL2200396 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized; Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | SHR-7367注射液 · No verified English nameCXSL2200394 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200393 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200392 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | LM-102注射液 · No verified English nameCXSL2200391 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | IMM2520注射液 · No verified English nameCXSL2200387 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/08/23New drug · Class 1 | ATG-037胶囊 · No verified English nameCXHL2200612 | De Li (Zhejiang) Pharmaceuticals 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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